{"version":"1.0.0","segments":[{"startTime":0.0,"endTime":2.035,"body":"[AI-assisted transcript]"},{"speaker":"Jeff Cranmer","startTime":2.035,"endTime":6.773,"body":"Rumors fly about an"},{"speaker":"Jeff Cranmer","startTime":2.035,"endTime":6.773,"body":"AstraZeneca-Bristol Myers mega merger,"},{"speaker":"Jeff Cranmer","startTime":6.906,"endTime":9.075,"body":"but would such a deal make sense?"},{"speaker":"Jeff Cranmer","startTime":9.376,"endTime":13.713,"body":"We'll discuss on the latest"},{"speaker":"Jeff Cranmer","startTime":9.376,"endTime":13.713,"body":"BioCentury This Week podcast."},{"speaker":"Jeff Cranmer","startTime":13.947,"endTime":22.322,"body":"Plus, Replimune's RP1 has had quite"},{"speaker":"Jeff Cranmer","startTime":13.947,"endTime":22.322,"body":"a biotech-style rollercoaster ride."},{"speaker":"Jeff Cranmer","startTime":22.555,"endTime":26.426,"body":"What are the lessons from the advisory"},{"speaker":"Jeff Cranmer","startTime":22.555,"endTime":26.426,"body":"committee meeting from last week?"},{"speaker":"Jeff Cranmer","startTime":26.593,"endTime":31.531,"body":"And we'll map the psychedelics"},{"speaker":"Jeff Cranmer","startTime":26.593,"endTime":31.531,"body":"frontier in depression."},{"speaker":"Jeff Cranmer","startTime":31.831,"endTime":37.337,"body":"Joining me today on the BioCentury"},{"speaker":"Jeff Cranmer","startTime":31.831,"endTime":37.337,"body":"This Week podcast, we have, of course,"},{"speaker":"Jeff Cranmer","startTime":37.504,"endTime":42.409,"body":"Editor-in-chief Simone Fishburn,"},{"speaker":"Jeff Cranmer","startTime":37.504,"endTime":42.409,"body":"today joining us from the best coast."},{"speaker":"Jeff Cranmer","startTime":42.575,"endTime":47.647,"body":"For those who don't know, it, uh, starts"},{"speaker":"Jeff Cranmer","startTime":42.575,"endTime":47.647,"body":"with a W. my fellow Executive Editor,"},{"speaker":"Jeff Cranmer","startTime":47.981,"endTime":54.287,"body":"Selina Koch, our Washington Editor,"},{"speaker":"Jeff Cranmer","startTime":47.981,"endTime":54.287,"body":"Steve Usdin, and our jack-of-all-trades"},{"speaker":"Jeff Cranmer","startTime":54.287,"endTime":58.892,"body":"man in the UK, resident Minnesota"},{"speaker":"Jeff Cranmer","startTime":54.287,"endTime":58.892,"body":"Vikings fan, Stephen Hansen."},{"speaker":"Jeff Cranmer","startTime":59.292,"endTime":64.497,"body":"Well, the Financial Times caused"},{"speaker":"Jeff Cranmer","startTime":59.292,"endTime":64.497,"body":"quite a stir over the weekend,"},{"speaker":"Jeff Cranmer","startTime":64.731,"endTime":71.171,"body":"reporting that AZ and BMS had been"},{"speaker":"Jeff Cranmer","startTime":64.731,"endTime":71.171,"body":"in talks about a mega merger, wow,"},{"speaker":"Jeff Cranmer","startTime":71.171,"endTime":73.44,"body":"that, that woke me up when I saw it."},{"speaker":"Jeff Cranmer","startTime":73.973,"endTime":76.076,"body":"Stephen, what do you make of this?"},{"speaker":"Stephen Hansen","startTime":76.476,"endTime":78.311,"body":"Well, I saw"},{"speaker":"Stephen Hansen","startTime":76.476,"endTime":78.311,"body":"this and I just found it a"},{"speaker":"Stephen Hansen","startTime":78.311,"endTime":79.512,"body":"bit annoying, if I'm honest."},{"speaker":"Stephen Hansen","startTime":80.346,"endTime":83.783,"body":"Um, yeah, it's, uh, not a"},{"speaker":"Stephen Hansen","startTime":80.346,"endTime":83.783,"body":"great idea in my opinion."},{"speaker":"Stephen Hansen","startTime":83.917,"endTime":88.488,"body":"I'm not sure if I can recall off the top"},{"speaker":"Stephen Hansen","startTime":83.917,"endTime":88.488,"body":"of my head the last time that one of these"},{"speaker":"Stephen Hansen","startTime":88.521,"endTime":92.826,"body":"mega mergers was a good idea to start"},{"speaker":"Stephen Hansen","startTime":88.521,"endTime":92.826,"body":"with, but this one in particular, doesn't"},{"speaker":"Stephen Hansen","startTime":92.826,"endTime":97.097,"body":"really strike me, as, as one that, that"},{"speaker":"Stephen Hansen","startTime":92.826,"endTime":97.097,"body":"I would really expect to go anywhere."},{"speaker":"Stephen Hansen","startTime":97.097,"endTime":100.233,"body":"Part-- I mean, partly I think it's"},{"speaker":"Stephen Hansen","startTime":97.097,"endTime":100.233,"body":"just because… So AstraZeneca has"},{"speaker":"Stephen Hansen","startTime":100.233,"endTime":104.938,"body":"been one of the best performing pharma"},{"speaker":"Stephen Hansen","startTime":100.233,"endTime":104.938,"body":"companies over the past five, plus years."},{"speaker":"Stephen Hansen","startTime":104.971,"endTime":109.542,"body":"They've-- I think I looked in five"},{"speaker":"Stephen Hansen","startTime":104.971,"endTime":109.542,"body":"years, they've got fifty percent sort"},{"speaker":"Stephen Hansen","startTime":109.542,"endTime":113.746,"body":"of share price appreciation, you know,"},{"speaker":"Stephen Hansen","startTime":109.542,"endTime":113.746,"body":"not including, you know, increasing"},{"speaker":"Stephen Hansen","startTime":113.746,"endTime":115.014,"body":"dividends and that sort of thing."},{"speaker":"Stephen Hansen","startTime":115.415,"endTime":118.985,"body":"Bristol has been one of the"},{"speaker":"Stephen Hansen","startTime":115.415,"endTime":118.985,"body":"most underperforming pharmas."},{"speaker":"Stephen Hansen","startTime":119.018,"endTime":122.522,"body":"I think they were up like four percent,"},{"speaker":"Stephen Hansen","startTime":119.018,"endTime":122.522,"body":"I think, over that same period."},{"speaker":"Stephen Hansen","startTime":123.189,"endTime":126.226,"body":"And, I know everyone's been sort of"},{"speaker":"Stephen Hansen","startTime":123.189,"endTime":126.226,"body":"talking about each of them have their"},{"speaker":"Stephen Hansen","startTime":126.226,"endTime":129.596,"body":"own sort of separate LOE sort of,"},{"speaker":"Stephen Hansen","startTime":126.226,"endTime":129.596,"body":"uh, you know, loss of exclusivity"},{"speaker":"Stephen Hansen","startTime":129.596,"endTime":130.53,"body":"challenges that they're facing."},{"speaker":"Stephen Hansen","startTime":130.53,"endTime":132.832,"body":"But AZ's already been through one."},{"speaker":"Stephen Hansen","startTime":132.866,"endTime":137.07,"body":"I mean, they lost quite a bit from their"},{"speaker":"Stephen Hansen","startTime":132.866,"endTime":137.07,"body":"inhaled and their,   cardiovascular"},{"speaker":"Stephen Hansen","startTime":137.07,"endTime":140.406,"body":"portfolio that's, that's gone off patent,"},{"speaker":"Stephen Hansen","startTime":137.07,"endTime":140.406,"body":"and they've made it through that and"},{"speaker":"Stephen Hansen","startTime":140.406,"endTime":142.775,"body":"are still on a good growth trajectory."},{"speaker":"Stephen Hansen","startTime":142.775,"endTime":147.18,"body":"So and, and, and on top of that,"},{"speaker":"Stephen Hansen","startTime":142.775,"endTime":147.18,"body":"they still have a lot of really good"},{"speaker":"Stephen Hansen","startTime":147.213,"endTime":150.416,"body":"growth drivers that are, that are"},{"speaker":"Stephen Hansen","startTime":147.213,"endTime":150.416,"body":"just coming, coming into the fore."},{"speaker":"Stephen Hansen","startTime":150.416,"endTime":154.621,"body":"So I just never would've, you"},{"speaker":"Stephen Hansen","startTime":150.416,"endTime":154.621,"body":"know, singled them out as a"},{"speaker":"Stephen Hansen","startTime":154.621,"endTime":158.424,"body":"company that needs something"},{"speaker":"Stephen Hansen","startTime":154.621,"endTime":158.424,"body":"like this, sort of going forward."},{"speaker":"Stephen Hansen","startTime":158.458,"endTime":162.128,"body":"And, uh, that's why I was actually"},{"speaker":"Stephen Hansen","startTime":158.458,"endTime":162.128,"body":"just quite shocked when I saw the"},{"speaker":"Stephen Hansen","startTime":162.128,"endTime":166.065,"body":"headline, and I was like, \" Okay, I"},{"speaker":"Stephen Hansen","startTime":162.128,"endTime":166.065,"body":"can understand BMS being involved in"},{"speaker":"Stephen Hansen","startTime":166.065,"endTime":171.104,"body":"a mega merger talk of some sort, but I"},{"speaker":"Stephen Hansen","startTime":166.065,"endTime":171.104,"body":"would never have put AZ as the, party"},{"speaker":"Stephen Hansen","startTime":171.104,"endTime":172.272,"body":"on the other side of that table.\""},{"speaker":"Simone Fishburn","startTime":173.139,"endTime":173.439,"body":"Yeah."},{"speaker":"Simone Fishburn","startTime":173.439,"endTime":175.808,"body":"So Stephen, um, couple of points."},{"speaker":"Simone Fishburn","startTime":175.808,"endTime":181.848,"body":"First of all, on the whole, I do not"},{"speaker":"Simone Fishburn","startTime":175.808,"endTime":181.848,"body":"comment on other media, um, and the, you"},{"speaker":"Simone Fishburn","startTime":181.848,"endTime":187.453,"body":"know, Finan- Financial Times is obviously"},{"speaker":"Simone Fishburn","startTime":181.848,"endTime":187.453,"body":"a, a very, very good, uh, newspaper."},{"speaker":"Simone Fishburn","startTime":187.82,"endTime":193.359,"body":"They did 100% get wrong their call-out"},{"speaker":"Simone Fishburn","startTime":187.82,"endTime":193.359,"body":"on the Chancellor, of the Exchequer"},{"speaker":"Simone Fishburn","startTime":193.359,"endTime":196.329,"body":"in the UK, for which I think they're"},{"speaker":"Simone Fishburn","startTime":193.359,"endTime":196.329,"body":"still eating a little bit of crow and"},{"speaker":"Simone Fishburn","startTime":196.329,"endTime":197.997,"body":"explaining that it was true at the time."},{"speaker":"Simone Fishburn","startTime":198.364,"endTime":200.833,"body":"And so maybe this is another"},{"speaker":"Simone Fishburn","startTime":198.364,"endTime":200.833,"body":"one of these stories that is"},{"speaker":"Simone Fishburn","startTime":200.833,"endTime":202.535,"body":"true at the time of reporting."},{"speaker":"Simone Fishburn","startTime":202.969,"endTime":204.504,"body":"the point is, I'm, I'm with you."},{"speaker":"Simone Fishburn","startTime":204.504,"endTime":209.275,"body":"Like, I think of all pharma CEOs in"},{"speaker":"Simone Fishburn","startTime":204.504,"endTime":209.275,"body":"the last 10 years, you've got Dave"},{"speaker":"Simone Fishburn","startTime":209.275,"endTime":212.812,"body":"Ricks, who's done a phenomenal thing"},{"speaker":"Simone Fishburn","startTime":209.275,"endTime":212.812,"body":"at Lilly, no two ways about it."},{"speaker":"Simone Fishburn","startTime":213.213,"endTime":217.483,"body":"But actually, in terms of actually"},{"speaker":"Simone Fishburn","startTime":213.213,"endTime":217.483,"body":"engineering the progress, Pascal"},{"speaker":"Simone Fishburn","startTime":217.517,"endTime":219.385,"body":"Soriot probably rises above."},{"speaker":"Simone Fishburn","startTime":219.419,"endTime":222.255,"body":"I mean, um, noth- nothing against"},{"speaker":"Simone Fishburn","startTime":219.419,"endTime":222.255,"body":"Ricks, and it's not a, a relevant"},{"speaker":"Simone Fishburn","startTime":222.255,"endTime":225.825,"body":"thing, but he has really been a"},{"speaker":"Simone Fishburn","startTime":222.255,"endTime":225.825,"body":"CEO that oversaw that turnaround."},{"speaker":"Simone Fishburn","startTime":225.825,"endTime":226.893,"body":"And you've … You're right."},{"speaker":"Simone Fishburn","startTime":226.893,"endTime":229.696,"body":"He's put them in this position"},{"speaker":"Simone Fishburn","startTime":226.893,"endTime":229.696,"body":"that like, why do you want"},{"speaker":"Simone Fishburn","startTime":229.696,"endTime":231.364,"body":"to go to BMS kind of thing."},{"speaker":"Simone Fishburn","startTime":231.598,"endTime":236.102,"body":"So there is this idea, and the reason"},{"speaker":"Simone Fishburn","startTime":231.598,"endTime":236.102,"body":"I'm chan- what I'm channeling is here,"},{"speaker":"Simone Fishburn","startTime":236.102,"endTime":241.541,"body":"there's a lot of nervousness in the"},{"speaker":"Simone Fishburn","startTime":236.102,"endTime":241.541,"body":"U.K. even before, but, you know, with"},{"speaker":"Simone Fishburn","startTime":242.408,"endTime":245.945,"body":"AstraZeneca saying it was gonna pull"},{"speaker":"Simone Fishburn","startTime":242.408,"endTime":245.945,"body":"out its R\u0026D or pull back, then they"},{"speaker":"Simone Fishburn","startTime":245.945,"endTime":248.381,"body":"listed in the New York Stock Exchange."},{"speaker":"Simone Fishburn","startTime":248.681,"endTime":254.387,"body":"So I feel like this article by the FT"},{"speaker":"Simone Fishburn","startTime":248.681,"endTime":254.387,"body":"taps this vibe of we might be losing"},{"speaker":"Simone Fishburn","startTime":254.387,"endTime":260.66,"body":"one of our crown jewels to those dirty,"},{"speaker":"Simone Fishburn","startTime":254.387,"endTime":260.66,"body":"you know, tax evader U- US people who,"},{"speaker":"Simone Fishburn","startTime":260.994,"endTime":264.664,"body":"you know broke away from us all those"},{"speaker":"Simone Fishburn","startTime":260.994,"endTime":264.664,"body":"years ago or something like that."},{"speaker":"Simone Fishburn","startTime":265.031,"endTime":266.566,"body":"Um, I don't know."},{"speaker":"Simone Fishburn","startTime":266.566,"endTime":269.736,"body":"I don't know if that'll go anywhere, and"},{"speaker":"Simone Fishburn","startTime":266.566,"endTime":269.736,"body":"I don't think we have to spend too much."},{"speaker":"Simone Fishburn","startTime":269.736,"endTime":273.539,"body":"But I, I do think in a way, for me,"},{"speaker":"Simone Fishburn","startTime":269.736,"endTime":273.539,"body":"the response of the UK and nervousness"},{"speaker":"Simone Fishburn","startTime":273.539,"endTime":274.774,"body":"over losing AstraZeneca or even losing"},{"speaker":"Simone Fishburn","startTime":276.876,"endTime":280.513,"body":"a lot of its influence, you know,"},{"speaker":"Simone Fishburn","startTime":276.876,"endTime":280.513,"body":"that, that really speaks to,"},{"speaker":"Simone Fishburn","startTime":281.18,"endTime":282.348,"body":"sort of where it is right now"},{"speaker":"Stephen Hansen","startTime":282.949,"endTime":283.383,"body":"Yeah."},{"speaker":"Selina Koch","startTime":283.716,"endTime":285.785,"body":"Can we"},{"speaker":"Selina Koch","startTime":283.716,"endTime":285.785,"body":"speculate on the other side?"},{"speaker":"Selina Koch","startTime":285.785,"endTime":288.688,"body":"So, so if we think AZ has made a"},{"speaker":"Selina Koch","startTime":285.785,"endTime":288.688,"body":"bunch of really good decisions and"},{"speaker":"Selina Koch","startTime":288.688,"endTime":292.659,"body":"it's generally rational and logical,"},{"speaker":"Selina Koch","startTime":288.688,"endTime":292.659,"body":"what's what's the argument for?"},{"speaker":"Selina Koch","startTime":292.759,"endTime":296.696,"body":"Like, are there a set of technologies"},{"speaker":"Selina Koch","startTime":292.759,"endTime":296.696,"body":"it would get from BMS that if you"},{"speaker":"Selina Koch","startTime":296.696,"endTime":300.767,"body":"went out and bought every one of them"},{"speaker":"Selina Koch","startTime":296.696,"endTime":300.767,"body":"separately, it would, like, cost more?"},{"speaker":"Selina Koch","startTime":300.767,"endTime":302.435,"body":"Is there, is there any"},{"speaker":"Selina Koch","startTime":300.767,"endTime":302.435,"body":"argument to be made?"},{"speaker":"Stephen Hansen","startTime":303.202,"endTime":303.936,"body":"I don't think so."},{"speaker":"Stephen Hansen","startTime":304.337,"endTime":308.274,"body":"I mean, so there are particular things"},{"speaker":"Stephen Hansen","startTime":304.337,"endTime":308.274,"body":"that BMS has that, that might be a"},{"speaker":"Stephen Hansen","startTime":308.274,"endTime":313.046,"body":"decent fit, like their partnership"},{"speaker":"Stephen Hansen","startTime":308.274,"endTime":313.046,"body":"with BioNTech for the PD-L1 VEGF."},{"speaker":"Stephen Hansen","startTime":313.046,"endTime":316.716,"body":"But I can't believe that there"},{"speaker":"Stephen Hansen","startTime":313.046,"endTime":316.716,"body":"aren't other PD-1 and VEGFs they"},{"speaker":"Stephen Hansen","startTime":316.716,"endTime":322.255,"body":"could go get without having to do"},{"speaker":"Stephen Hansen","startTime":316.716,"endTime":322.255,"body":"a hundred and forty billion merger."},{"speaker":"Stephen Hansen","startTime":322.522,"endTime":324.257,"body":"They have assets in cell therapy."},{"speaker":"Stephen Hansen","startTime":324.59,"endTime":326.192,"body":"BMS obviously has assets in cell therapy."},{"speaker":"Stephen Hansen","startTime":326.192,"endTime":329.062,"body":"Maybe combining them together"},{"speaker":"Stephen Hansen","startTime":326.192,"endTime":329.062,"body":"might give them greater scale."},{"speaker":"Stephen Hansen","startTime":329.062,"endTime":332.965,"body":"But again, is that worth"},{"speaker":"Stephen Hansen","startTime":329.062,"endTime":332.965,"body":"this larger, larger deal?"},{"speaker":"Stephen Hansen","startTime":332.965,"endTime":336.402,"body":"It just-- There are individual assets"},{"speaker":"Stephen Hansen","startTime":332.965,"endTime":336.402,"body":"within BMS that I think are attractive,"},{"speaker":"Stephen Hansen","startTime":336.402,"endTime":340.473,"body":"but I don't know why you would spend"},{"speaker":"Stephen Hansen","startTime":336.402,"endTime":340.473,"body":"this much money to, to do that."},{"speaker":"Stephen Hansen","startTime":340.506,"endTime":344.01,"body":"And to go back to the point that"},{"speaker":"Stephen Hansen","startTime":340.506,"endTime":344.01,"body":"Simone was making about sort of the,"},{"speaker":"Stephen Hansen","startTime":344.077,"endTime":346.813,"body":"the nervousness around being in the"},{"speaker":"Stephen Hansen","startTime":344.077,"endTime":346.813,"body":"UK and stuff, and I know there's been"},{"speaker":"Stephen Hansen","startTime":347.146,"endTime":351.384,"body":"maybe a little speculation, like have"},{"speaker":"Stephen Hansen","startTime":347.146,"endTime":351.384,"body":"they, you know-- Did, someone leak this"},{"speaker":"Stephen Hansen","startTime":351.384,"endTime":355.755,"body":"as a way of trying to, improve AZ's"},{"speaker":"Stephen Hansen","startTime":351.384,"endTime":355.755,"body":"leverage or their, their positioning,"},{"speaker":"Stephen Hansen","startTime":355.755,"endTime":356.522,"body":"you know, with the government?"},{"speaker":"Stephen Hansen","startTime":356.522,"endTime":361.361,"body":"But I guess my pushback on that would"},{"speaker":"Stephen Hansen","startTime":356.522,"endTime":361.361,"body":"be, uh, at, at the time that we're"},{"speaker":"Stephen Hansen","startTime":361.361,"endTime":365.698,"body":"recording this, AZ stock is down"},{"speaker":"Stephen Hansen","startTime":361.361,"endTime":365.698,"body":"almost eight percent, which equates to"},{"speaker":"Stephen Hansen","startTime":365.698,"endTime":368.534,"body":"over twenty billion dollars in value."},{"speaker":"Stephen Hansen","startTime":368.634,"endTime":372.939,"body":"And so that seems like a f-- I mean,"},{"speaker":"Stephen Hansen","startTime":368.634,"endTime":372.939,"body":"you can maybe argue that the moment"},{"speaker":"Stephen Hansen","startTime":372.939,"endTime":375.742,"body":"this goes away, you know, that"},{"speaker":"Stephen Hansen","startTime":372.939,"endTime":375.742,"body":"bounces right back, and maybe it"},{"speaker":"Stephen Hansen","startTime":375.742,"endTime":377.076,"body":"doesn't actually cost them anything."},{"speaker":"Stephen Hansen","startTime":377.076,"endTime":382.615,"body":"But, it seems like a steep price to pay"},{"speaker":"Stephen Hansen","startTime":377.076,"endTime":382.615,"body":"if, if this hangs on a little bit for, I"},{"speaker":"Stephen Hansen","startTime":382.615,"endTime":384.55,"body":"don't know, manufacturing that leverage."},{"speaker":"Stephen Hansen","startTime":384.951,"endTime":387.787,"body":"yeah, it just-- Th-that was what struck"},{"speaker":"Stephen Hansen","startTime":384.951,"endTime":387.787,"body":"me the most, I guess, was just the,"},{"speaker":"Stephen Hansen","startTime":387.82,"endTime":392.759,"body":"the investor reaction spoke to how--"},{"speaker":"Stephen Hansen","startTime":387.82,"endTime":392.759,"body":"to m-my mind, spoke to how much AZ"},{"speaker":"Stephen Hansen","startTime":392.759,"endTime":396.829,"body":"investors don't like this idea, don't"},{"speaker":"Stephen Hansen","startTime":392.759,"endTime":396.829,"body":"think they need to bring on any of this."},{"speaker":"Stephen Hansen","startTime":396.829,"endTime":399.665,"body":"And, and I mean, frankly, I know everyone"},{"speaker":"Stephen Hansen","startTime":396.829,"endTime":399.665,"body":"else will have already pointed this"},{"speaker":"Stephen Hansen","startTime":399.665,"endTime":404.67,"body":"out, but, when BMS bought Celgene, they"},{"speaker":"Stephen Hansen","startTime":399.665,"endTime":404.67,"body":"were so tied up in that integration"},{"speaker":"Stephen Hansen","startTime":404.67,"endTime":409.041,"body":"that they were basically absent from"},{"speaker":"Stephen Hansen","startTime":404.67,"endTime":409.041,"body":"the buyer's market for several years."},{"speaker":"Stephen Hansen","startTime":409.041,"endTime":412.111,"body":"I think when I looked in our database,"},{"speaker":"Stephen Hansen","startTime":409.041,"endTime":412.111,"body":"it was like two or three years, I think,"},{"speaker":"Stephen Hansen","startTime":412.111,"endTime":414.013,"body":"before they did another major acquisition."},{"speaker":"Stephen Hansen","startTime":414.747,"endTime":418.484,"body":"And so you would effectively be"},{"speaker":"Stephen Hansen","startTime":414.747,"endTime":418.484,"body":"removing, you know, two buyers from the"},{"speaker":"Stephen Hansen","startTime":418.484,"endTime":421.053,"body":"market effectively for the next couple"},{"speaker":"Stephen Hansen","startTime":418.484,"endTime":421.053,"body":"of years if this were to go through."},{"speaker":"Stephen Hansen","startTime":421.053,"endTime":421.354,"body":"So,"},{"speaker":"Simone Fishburn","startTime":421.854,"endTime":423.89,"body":"I will just say, going"},{"speaker":"Simone Fishburn","startTime":421.854,"endTime":423.89,"body":"back to Selina's point, there's, there's"},{"speaker":"Simone Fishburn","startTime":423.89,"endTime":428.795,"body":"only one thing, which is I think we"},{"speaker":"Simone Fishburn","startTime":423.89,"endTime":428.795,"body":"can agree Pascal Soriot is very smart"},{"speaker":"Simone Fishburn","startTime":428.795,"endTime":430.196,"body":"guy and he's done a lot of good things."},{"speaker":"Simone Fishburn","startTime":430.43,"endTime":433.966,"body":"It's always a question with things like"},{"speaker":"Simone Fishburn","startTime":430.43,"endTime":433.966,"body":"this is like, is there something up his"},{"speaker":"Simone Fishburn","startTime":433.966,"endTime":439.238,"body":"sleeve that everybody else just isn't"},{"speaker":"Simone Fishburn","startTime":433.966,"endTime":439.238,"body":"seeing, or did he just misread this?"},{"speaker":"Simone Fishburn","startTime":439.272,"endTime":441.507,"body":"You know, um, you know,"},{"speaker":"Simone Fishburn","startTime":439.272,"endTime":441.507,"body":"or is it true, or did he"},{"speaker":"Stephen Hansen","startTime":441.808,"endTime":443.009,"body":"Or is it complete, is it?"},{"speaker":"Simone Fishburn","startTime":443.109,"endTime":443.443,"body":"yeah."},{"speaker":"Simone Fishburn","startTime":443.476,"endTime":444.377,"body":"So we could, yeah"},{"speaker":"Selina Koch","startTime":444.61,"endTime":445.244,"body":"Yeah, yeah."},{"speaker":"Selina Koch","startTime":445.278,"endTime":448.214,"body":"The level of the talks may"},{"speaker":"Selina Koch","startTime":445.278,"endTime":448.214,"body":"not be as advanced as they or"},{"speaker":"Selina Koch","startTime":448.214,"endTime":448.614,"body":"they're making it out to be."},{"speaker":"Jeff Cranmer","startTime":448.614,"endTime":450.383,"body":"Could have just"},{"speaker":"Jeff Cranmer","startTime":448.614,"endTime":450.383,"body":"been a cup of coffee, uh,"},{"speaker":"Selina Koch","startTime":450.65,"endTime":450.817,"body":"yeah"},{"speaker":"Stephen Hansen","startTime":451.551,"endTime":452.185,"body":"Exactly."},{"speaker":"Jeff Cranmer","startTime":452.318,"endTime":455.087,"body":"somebody"},{"speaker":"Jeff Cranmer","startTime":452.318,"endTime":455.087,"body":"spotted him having espressos."},{"speaker":"Jeff Cranmer","startTime":455.354,"endTime":456.088,"body":"excellent."},{"speaker":"Jeff Cranmer","startTime":456.122,"endTime":458.491,"body":"Well, Stephen, look forward"},{"speaker":"Jeff Cranmer","startTime":456.122,"endTime":458.491,"body":"to reading your piece."},{"speaker":"Jeff Cranmer","startTime":458.524,"endTime":461.961,"body":"Uh, we'll drop a, a"},{"speaker":"Jeff Cranmer","startTime":458.524,"endTime":461.961,"body":"link in the show notes."},{"speaker":"Jeff Cranmer","startTime":462.395,"endTime":465.798,"body":"And, uh, get back to that"},{"speaker":"Jeff Cranmer","startTime":462.395,"endTime":465.798,"body":"pasta you're making, Stephen."},{"speaker":"Jeff Cranmer","startTime":465.798,"endTime":467.5,"body":"Uh, you… Sounds delicious."},{"speaker":"Jeff Cranmer","startTime":467.5,"endTime":468.167,"body":"Send, uh,"},{"speaker":"Jeff Cranmer","startTime":468.534,"endTime":469.735,"body":"send, send a little bit"},{"speaker":"Jeff Cranmer","startTime":469.769,"endTime":470.002,"body":"to"},{"speaker":"Simone Fishburn","startTime":470.236,"endTime":472.138,"body":"I think the"},{"speaker":"Simone Fishburn","startTime":470.236,"endTime":472.138,"body":"listeners need to know that it's"},{"speaker":"Simone Fishburn","startTime":472.138,"endTime":474.574,"body":"a Napolitano's sauce today, right?"},{"speaker":"Stephen Hansen","startTime":475.174,"endTime":476.375,"body":"Yeah, with lots of chili."},{"speaker":"Stephen Hansen","startTime":476.509,"endTime":478.077,"body":"So it's, it's a good spicy sauce"},{"speaker":"Jeff Cranmer","startTime":478.678,"endTime":483.249,"body":"Uh, food, food is often"},{"speaker":"Jeff Cranmer","startTime":478.678,"endTime":483.249,"body":"very top of mind here at, at BioCentury."},{"speaker":"Jeff Cranmer","startTime":483.316,"endTime":486.686,"body":"Uh, it occupies at least,"},{"speaker":"Jeff Cranmer","startTime":483.316,"endTime":486.686,"body":"at least two Slack channels."},{"speaker":"Jeff Cranmer","startTime":487.32,"endTime":492.592,"body":"All right, uh, let's head"},{"speaker":"Jeff Cranmer","startTime":487.32,"endTime":492.592,"body":"over to FDA and Replimune."},{"speaker":"Jeff Cranmer","startTime":492.892,"endTime":496.229,"body":"Steve, wow, talk about"},{"speaker":"Jeff Cranmer","startTime":492.892,"endTime":496.229,"body":"rollercoaster rides."},{"speaker":"Jeff Cranmer","startTime":496.696,"endTime":501.2,"body":"CRLs, setbacks, agreements"},{"speaker":"Jeff Cranmer","startTime":496.696,"endTime":501.2,"body":"with FDA that went poof."},{"speaker":"Jeff Cranmer","startTime":501.667,"endTime":505.872,"body":"And then, uh, well, briefing"},{"speaker":"Jeff Cranmer","startTime":501.667,"endTime":505.872,"body":"documents came out last week."},{"speaker":"Jeff Cranmer","startTime":506.472,"endTime":507.974,"body":"stock plummeted."},{"speaker":"Jeff Cranmer","startTime":508.407,"endTime":511.811,"body":"Uh, advisory committee, the,"},{"speaker":"Jeff Cranmer","startTime":508.407,"endTime":511.811,"body":"uh, the experts on the advisory"},{"speaker":"Jeff Cranmer","startTime":511.811,"endTime":513.145,"body":"committee felt a little differently."},{"speaker":"Jeff Cranmer","startTime":513.145,"endTime":515.982,"body":"Stock, uh, made a round"},{"speaker":"Jeff Cranmer","startTime":513.145,"endTime":515.982,"body":"trip, and here we are."},{"speaker":"Jeff Cranmer","startTime":516.315,"endTime":518.117,"body":"What sense are you making"},{"speaker":"Jeff Cranmer","startTime":516.315,"endTime":518.117,"body":"of all this, Steve?"},{"speaker":"Steve Usdin","startTime":518.451,"endTime":521.754,"body":"So first we should say,"},{"speaker":"Steve Usdin","startTime":518.451,"endTime":521.754,"body":"look, we're recording this at one"},{"speaker":"Steve Usdin","startTime":521.888,"endTime":524.757,"body":"twenty PM on Monday, Washington time."},{"speaker":"Steve Usdin","startTime":525.157,"endTime":529.095,"body":"There hasn't been a decision"},{"speaker":"Steve Usdin","startTime":525.157,"endTime":529.095,"body":"announced about, approval or not"},{"speaker":"Jeff Cranmer","startTime":529.295,"endTime":530.363,"body":"A good, good point."},{"speaker":"Jeff Cranmer","startTime":530.396,"endTime":530.63,"body":"Yeah"},{"speaker":"Steve Usdin","startTime":530.763,"endTime":531.631,"body":"of RP1."},{"speaker":"Steve Usdin","startTime":531.964,"endTime":534.634,"body":"the PDUFA date was actually, yesterday."},{"speaker":"Steve Usdin","startTime":534.634,"endTime":537.436,"body":"So, you know, by the time people"},{"speaker":"Steve Usdin","startTime":534.634,"endTime":537.436,"body":"are listening to this, they may"},{"speaker":"Steve Usdin","startTime":537.436,"endTime":539.672,"body":"know more about it than we do now."},{"speaker":"Steve Usdin","startTime":539.939,"endTime":541.173,"body":"So what do we know now?"},{"speaker":"Steve Usdin","startTime":541.34,"endTime":545.578,"body":"FDA Cellular Tissue and Gene Therapies"},{"speaker":"Steve Usdin","startTime":541.34,"endTime":545.578,"body":"Advisory Committee voted ten to"},{"speaker":"Steve Usdin","startTime":545.578,"endTime":549.582,"body":"three on July 30th that the efficacy"},{"speaker":"Steve Usdin","startTime":545.578,"endTime":549.582,"body":"results from Replimune's IGNYTE"},{"speaker":"Steve Usdin","startTime":549.949,"endTime":555.855,"body":"trial of, RP1 plus Opdivo are, uh,"},{"speaker":"Steve Usdin","startTime":549.949,"endTime":555.855,"body":"valuable and clinically meaningful."},{"speaker":"Steve Usdin","startTime":556.155,"endTime":558.524,"body":"The panel was not asked"},{"speaker":"Steve Usdin","startTime":556.155,"endTime":558.524,"body":"whether to approve the drug."},{"speaker":"Steve Usdin","startTime":558.858,"endTime":562.995,"body":"It voted against the written"},{"speaker":"Steve Usdin","startTime":558.858,"endTime":562.995,"body":"recommendation of the review team, which"},{"speaker":"Steve Usdin","startTime":562.995,"endTime":567.967,"body":"it concluded that IGNYTE was not an"},{"speaker":"Steve Usdin","startTime":562.995,"endTime":567.967,"body":"adequate and well-controlled trial, and"},{"speaker":"Steve Usdin","startTime":567.967,"endTime":572.572,"body":"that's the same finding that produced"},{"speaker":"Steve Usdin","startTime":567.967,"endTime":572.572,"body":"two complete response letters in roughly"},{"speaker":"Steve Usdin","startTime":572.572,"endTime":577.076,"body":"a year The dispute really, and this"},{"speaker":"Steve Usdin","startTime":572.572,"endTime":577.076,"body":"is what the AdCom was looking at, was"},{"speaker":"Steve Usdin","startTime":577.076,"endTime":583.549,"body":"about two issues, measurement of the"},{"speaker":"Steve Usdin","startTime":577.076,"endTime":583.549,"body":"systemic effect of RP1 and the relative"},{"speaker":"Steve Usdin","startTime":583.549,"endTime":589.322,"body":"contribution of RP1 and Opdivo to any"},{"speaker":"Steve Usdin","startTime":583.549,"endTime":589.322,"body":"systemic effect that was detected."},{"speaker":"Steve Usdin","startTime":589.722,"endTime":594.493,"body":"it, it gets nerdy really quick here,"},{"speaker":"Steve Usdin","startTime":589.722,"endTime":594.493,"body":"but basically, one of the problems and"},{"speaker":"Steve Usdin","startTime":594.493,"endTime":598.965,"body":"that, and that the advisory committee"},{"speaker":"Steve Usdin","startTime":594.493,"endTime":598.965,"body":"pointed to is that the RECIST, criteria"},{"speaker":"Steve Usdin","startTime":599.065,"endTime":605.004,"body":"to assess systemic therapies, treats,"},{"speaker":"Steve Usdin","startTime":599.065,"endTime":605.004,"body":"lesions that have, been treated as"},{"speaker":"Steve Usdin","startTime":605.037,"endTime":606.906,"body":"non-measurable unless they grow."},{"speaker":"Steve Usdin","startTime":607.406,"endTime":612.144,"body":"So the IGNYTE protocol specified that"},{"speaker":"Steve Usdin","startTime":607.406,"endTime":612.144,"body":"as many lesions as possible should be"},{"speaker":"Steve Usdin","startTime":612.144,"endTime":616.515,"body":"injected because the theory is that"},{"speaker":"Steve Usdin","startTime":612.144,"endTime":616.515,"body":"injection is the route of administration,"},{"speaker":"Steve Usdin","startTime":616.749,"endTime":621.187,"body":"and the injected tumor is the"},{"speaker":"Steve Usdin","startTime":616.749,"endTime":621.187,"body":"priming site for the immune response."},{"speaker":"Steve Usdin","startTime":621.554,"endTime":624.156,"body":"So those rules are kind"},{"speaker":"Steve Usdin","startTime":621.554,"endTime":624.156,"body":"of incompatible, right?"},{"speaker":"Steve Usdin","startTime":624.624,"endTime":630.963,"body":"So 53% of Replimune's,"},{"speaker":"Steve Usdin","startTime":624.624,"endTime":630.963,"body":"responders didn't have any target"},{"speaker":"Steve Usdin","startTime":630.997,"endTime":632.932,"body":"lesions that weren't injected."},{"speaker":"Steve Usdin","startTime":633.466,"endTime":637.57,"body":"So according to FDA, you couldn't"},{"speaker":"Steve Usdin","startTime":633.466,"endTime":637.57,"body":"really determine whether there was"},{"speaker":"Steve Usdin","startTime":637.57,"endTime":640.406,"body":"a systemic effect in those patients."},{"speaker":"Steve Usdin","startTime":640.773,"endTime":645.144,"body":"So FDA's primary analysis said,"},{"speaker":"Steve Usdin","startTime":640.773,"endTime":645.144,"body":"\"Okay, there's 140 patients."},{"speaker":"Steve Usdin","startTime":645.344,"endTime":650.383,"body":"Remove 53% of them, from the numerator"},{"speaker":"Steve Usdin","startTime":645.344,"endTime":650.383,"body":"because you can't tell whether there"},{"speaker":"Steve Usdin","startTime":650.383,"endTime":655.521,"body":"was a, a systemic response according"},{"speaker":"Steve Usdin","startTime":650.383,"endTime":655.521,"body":"to the, RECIST criteria.\" and that"},{"speaker":"Steve Usdin","startTime":655.554,"endTime":659.525,"body":"changed the, response rate from"},{"speaker":"Steve Usdin","startTime":655.554,"endTime":659.525,"body":"Replimune's 33.6% to FDA's 15.7%, uh,"},{"speaker":"Steve Usdin","startTime":659.525,"endTime":663.696,"body":"and the duration of response from 24.8"},{"speaker":"Steve Usdin","startTime":666.899,"endTime":668.634,"body":"months to 14.1 months."},{"speaker":"Steve Usdin","startTime":668.634,"endTime":670.87,"body":"So that was a fundamental question."},{"speaker":"Steve Usdin","startTime":671.27,"endTime":674.206,"body":"The secondary question was"},{"speaker":"Steve Usdin","startTime":671.27,"endTime":674.206,"body":"contribution of effect."},{"speaker":"Steve Usdin","startTime":674.573,"endTime":680.68,"body":"If the responses are systemic, if there"},{"speaker":"Steve Usdin","startTime":674.573,"endTime":680.68,"body":"really are systemic responses, is that RP1"},{"speaker":"Steve Usdin","startTime":680.98,"endTime":684.684,"body":"or is that the Opdivo re-challenge, right?"},{"speaker":"Steve Usdin","startTime":684.95,"endTime":688.821,"body":"This came to the advisory committee"},{"speaker":"Steve Usdin","startTime":684.95,"endTime":688.821,"body":"meeting,  and as I said, they voted 10 to"},{"speaker":"Steve Usdin","startTime":688.821,"endTime":693.926,"body":"three, that the results were interpretable"},{"speaker":"Steve Usdin","startTime":688.821,"endTime":693.926,"body":"I think there's some lessons that came out"},{"speaker":"Steve Usdin","startTime":693.926,"endTime":696.028,"body":"of this for companies, and for patients."},{"speaker":"Steve Usdin","startTime":696.429,"endTime":701.333,"body":"One is that, um, advisory committees,"},{"speaker":"Steve Usdin","startTime":696.429,"endTime":701.333,"body":"can serve as an appeals mechanism"},{"speaker":"Steve Usdin","startTime":701.667,"endTime":706.305,"body":"against, um, the judgment of,"},{"speaker":"Steve Usdin","startTime":701.667,"endTime":706.305,"body":"of an FDA, review division."},{"speaker":"Steve Usdin","startTime":706.605,"endTime":708.074,"body":"that's happened in the past."},{"speaker":"Steve Usdin","startTime":708.34,"endTime":712.878,"body":"It kind of, went away, under, former"},{"speaker":"Steve Usdin","startTime":708.34,"endTime":712.878,"body":"Commissioner Makary  Vinay Prasad."},{"speaker":"Steve Usdin","startTime":712.878,"endTime":713.846,"body":"It seems to be back."},{"speaker":"Steve Usdin","startTime":714.547,"endTime":717.717,"body":"The other thing is, you know, if you"},{"speaker":"Steve Usdin","startTime":714.547,"endTime":717.717,"body":"look at who was on the committee and who"},{"speaker":"Steve Usdin","startTime":717.717,"endTime":723.622,"body":"was really decisive, it really came down"},{"speaker":"Steve Usdin","startTime":717.717,"endTime":723.622,"body":"to, the impact, I think, of, clinicians"},{"speaker":"Steve Usdin","startTime":723.622,"endTime":727.026,"body":"on the committee, versus statisticians."},{"speaker":"Steve Usdin","startTime":727.46,"endTime":729.995,"body":"There was a lot of discussion, and"},{"speaker":"Steve Usdin","startTime":727.46,"endTime":729.995,"body":"I think this is something going"},{"speaker":"Steve Usdin","startTime":729.995,"endTime":734.867,"body":"forward that FDA is gonna talk about,"},{"speaker":"Steve Usdin","startTime":729.995,"endTime":734.867,"body":"about this issue of the, the target"},{"speaker":"Steve Usdin","startTime":734.867,"endTime":737.837,"body":"lesions and their impact on analysis."},{"speaker":"Steve Usdin","startTime":738.204,"endTime":742.908,"body":"I suspect that one of the things going"},{"speaker":"Steve Usdin","startTime":738.204,"endTime":742.908,"body":"forward is gonna be a greater em-emphasis"},{"speaker":"Steve Usdin","startTime":742.942,"endTime":747.847,"body":"on companies having,  a reserve of"},{"speaker":"Steve Usdin","startTime":742.942,"endTime":747.847,"body":"patients who don't have all of their,"},{"speaker":"Steve Usdin","startTime":748.147,"endTime":753.285,"body":"um, tumors injected so they can, look"},{"speaker":"Steve Usdin","startTime":748.147,"endTime":753.285,"body":"at systemic, effects, objectively."},{"speaker":"Steve Usdin","startTime":753.686,"endTime":757.656,"body":"The alternative to that would be some kind"},{"speaker":"Steve Usdin","startTime":753.686,"endTime":757.656,"body":"of redefinition, of looking at systemic"},{"speaker":"Steve Usdin","startTime":757.656,"endTime":759.592,"body":"effects, in this kind of situation."},{"speaker":"Steve Usdin","startTime":759.825,"endTime":764.764,"body":"One of the, panelists, said that FDA"},{"speaker":"Steve Usdin","startTime":759.825,"endTime":764.764,"body":"has a, a moral obligation, that was the"},{"speaker":"Steve Usdin","startTime":764.764,"endTime":769.135,"body":"term that he used, to kind of sort this"},{"speaker":"Steve Usdin","startTime":764.764,"endTime":769.135,"body":"out, to, to create, guidance because he"},{"speaker":"Steve Usdin","startTime":769.135,"endTime":773.172,"body":"said, you know, there, there are gonna be"},{"speaker":"Steve Usdin","startTime":769.135,"endTime":773.172,"body":"m-more, of these situations in the future."},{"speaker":"Steve Usdin","startTime":773.539,"endTime":777.743,"body":"And finally, you know, I, I think, it's"},{"speaker":"Steve Usdin","startTime":773.539,"endTime":777.743,"body":"clear the panelists said it themselves"},{"speaker":"Steve Usdin","startTime":778.01,"endTime":782.948,"body":"that the, public commentary, uh, the"},{"speaker":"Steve Usdin","startTime":778.01,"endTime":782.948,"body":"public comments, swayed, their decisions,"},{"speaker":"Steve Usdin","startTime":783.082,"endTime":784.65,"body":"um, that they were impacted by it."},{"speaker":"Steve Usdin","startTime":784.884,"endTime":787.253,"body":"And we've seen that before at"},{"speaker":"Steve Usdin","startTime":784.884,"endTime":787.253,"body":"advisory committee meetings."},{"speaker":"Steve Usdin","startTime":787.553,"endTime":791.09,"body":"I think that if you have a situation"},{"speaker":"Steve Usdin","startTime":787.553,"endTime":791.09,"body":"where you have passionate patient"},{"speaker":"Steve Usdin","startTime":791.09,"endTime":796.095,"body":"advocates and, um, clinicians who,"},{"speaker":"Steve Usdin","startTime":791.09,"endTime":796.095,"body":"who really want to do something for"},{"speaker":"Steve Usdin","startTime":796.095,"endTime":801.1,"body":"their patients on the one side, and"},{"speaker":"Steve Usdin","startTime":796.095,"endTime":801.1,"body":"FDA making an argue about-- an argument"},{"speaker":"Steve Usdin","startTime":801.1,"endTime":806.505,"body":"about statistics and interpretability"},{"speaker":"Steve Usdin","startTime":801.1,"endTime":806.505,"body":"of clinical trial results, in the"},{"speaker":"Steve Usdin","startTime":806.505,"endTime":810.209,"body":"heat of the moment, in the heat of the"},{"speaker":"Steve Usdin","startTime":806.505,"endTime":810.209,"body":"advisory committee meeting, it's likely"},{"speaker":"Steve Usdin","startTime":810.209,"endTime":813.679,"body":"that the clinicians and the patients"},{"speaker":"Steve Usdin","startTime":810.209,"endTime":813.679,"body":"are gonna be more persuasive than the"},{"speaker":"Steve Usdin","startTime":814.213,"endTime":818.851,"body":"argument about, statistics and, clinical"},{"speaker":"Steve Usdin","startTime":814.213,"endTime":818.851,"body":"trial design and things like that."},{"speaker":"Simone Fishburn","startTime":819.785,"endTime":823.088,"body":"So do you, w-"},{"speaker":"Simone Fishburn","startTime":819.785,"endTime":823.088,"body":"maybe you and Selina, like, what"},{"speaker":"Simone Fishburn","startTime":823.088,"endTime":827.76,"body":"is your opinion about FDA's … I"},{"speaker":"Simone Fishburn","startTime":823.088,"endTime":827.76,"body":"don't want to call it gymnastics."},{"speaker":"Simone Fishburn","startTime":827.793,"endTime":833.032,"body":"F- FDA's operations on the mathematics,"},{"speaker":"Simone Fishburn","startTime":827.793,"endTime":833.032,"body":"I mean, on the merits, is FDA right"},{"speaker":"Simone Fishburn","startTime":833.065,"endTime":838.204,"body":"that if they injected all of those"},{"speaker":"Simone Fishburn","startTime":833.065,"endTime":838.204,"body":"tumors, the consequence has to be to"},{"speaker":"Simone Fishburn","startTime":838.204,"endTime":841.373,"body":"remove those people from the statistics?"},{"speaker":"Steve Usdin","startTime":841.907,"endTime":844.443,"body":"Well, look, you know, I,"},{"speaker":"Steve Usdin","startTime":841.907,"endTime":844.443,"body":"I'm not an oncologist, and I, I don't"},{"speaker":"Steve Usdin","startTime":844.443,"endTime":846.045,"body":"even play one on the podcast, you know?"},{"speaker":"Steve Usdin","startTime":846.045,"endTime":849.682,"body":"So I, I, I just… I think it's"},{"speaker":"Steve Usdin","startTime":846.045,"endTime":849.682,"body":"good enough for me to just to try"},{"speaker":"Steve Usdin","startTime":849.682,"endTime":852.985,"body":"to explain, you know, what the"},{"speaker":"Steve Usdin","startTime":849.682,"endTime":852.985,"body":"logic on both sides of it was."},{"speaker":"Steve Usdin","startTime":853.085,"endTime":856.689,"body":"And, you know, it, it persuaded"},{"speaker":"Steve Usdin","startTime":853.085,"endTime":856.689,"body":"the clinicians who were on"},{"speaker":"Steve Usdin","startTime":856.689,"endTime":857.823,"body":"that advisory committee."},{"speaker":"Steve Usdin","startTime":858.424,"endTime":859.158,"body":"I would leave it at that."},{"speaker":"Steve Usdin","startTime":859.158,"endTime":860.926,"body":"I think, you know, time will tell, right?"},{"speaker":"Steve Usdin","startTime":861.093,"endTime":863.462,"body":"And this isn't the first time"},{"speaker":"Steve Usdin","startTime":861.093,"endTime":863.462,"body":"that this has happened, even with,"},{"speaker":"Steve Usdin","startTime":863.462,"endTime":867.266,"body":"with a very similar… There was a"},{"speaker":"Steve Usdin","startTime":863.462,"endTime":867.266,"body":"very similar, product to, to RP1,"},{"speaker":"Steve Usdin","startTime":867.566,"endTime":870.502,"body":"and an advisory committee that"},{"speaker":"Steve Usdin","startTime":867.566,"endTime":870.502,"body":"looked at very similar issues."},{"speaker":"Steve Usdin","startTime":870.736,"endTime":874.473,"body":"Ultimately, FDA, granted accelerated"},{"speaker":"Steve Usdin","startTime":870.736,"endTime":874.473,"body":"approval to that product."},{"speaker":"Steve Usdin","startTime":874.84,"endTime":878.11,"body":"It- it's not really being used very"},{"speaker":"Steve Usdin","startTime":874.84,"endTime":878.11,"body":"much now because in the real world,"},{"speaker":"Steve Usdin","startTime":878.11,"endTime":881.213,"body":"it turned out that it looked like it"},{"speaker":"Steve Usdin","startTime":878.11,"endTime":881.213,"body":"really doesn't provide much benefit."},{"speaker":"Steve Usdin","startTime":881.513,"endTime":883.282,"body":"I think that we'll find out."},{"speaker":"Steve Usdin","startTime":883.315,"endTime":887.319,"body":"You know, we'll find out, you know, in the"},{"speaker":"Steve Usdin","startTime":883.315,"endTime":887.319,"body":"months and years ahead who was right here."},{"speaker":"Simone Fishburn","startTime":887.386,"endTime":888.921,"body":"let me just"},{"speaker":"Simone Fishburn","startTime":887.386,"endTime":888.921,"body":"interrupt and, uh, let, let"},{"speaker":"Simone Fishburn","startTime":888.921,"endTime":890.022,"body":"me just ask a question there."},{"speaker":"Simone Fishburn","startTime":890.422,"endTime":893.325,"body":"I think one thing that wasn't clear"},{"speaker":"Simone Fishburn","startTime":890.422,"endTime":893.325,"body":"to me is what is the downside?"},{"speaker":"Simone Fishburn","startTime":893.325,"endTime":898.43,"body":"There's always this idea, right, a sort"},{"speaker":"Simone Fishburn","startTime":893.325,"endTime":898.43,"body":"of, of, of balancing risk and benefit."},{"speaker":"Simone Fishburn","startTime":898.731,"endTime":901.901,"body":"And you said, you know, and the sort"},{"speaker":"Simone Fishburn","startTime":898.731,"endTime":901.901,"body":"of, you know, one argument will always"},{"speaker":"Simone Fishburn","startTime":901.901,"endTime":905.404,"body":"be if it doesn't harm, let's put it out"},{"speaker":"Simone Fishburn","startTime":901.901,"endTime":905.404,"body":"there and let it, let, let's find out."},{"speaker":"Simone Fishburn","startTime":905.404,"endTime":908.307,"body":"Is there, is there a lot"},{"speaker":"Simone Fishburn","startTime":905.404,"endTime":908.307,"body":"of toxicity associated"},{"speaker":"Steve Usdin","startTime":908.307,"endTime":911.243,"body":"Yes, there, there to-"},{"speaker":"Steve Usdin","startTime":908.307,"endTime":911.243,"body":"there's toxicity associated with both"},{"speaker":"Steve Usdin","startTime":911.243,"endTime":916.382,"body":"elements, both arms of the, of the,"},{"speaker":"Steve Usdin","startTime":911.243,"endTime":916.382,"body":"combination and so, If it turns out"},{"speaker":"Steve Usdin","startTime":916.415,"endTime":921.62,"body":"that this doesn't work, patients will be"},{"speaker":"Steve Usdin","startTime":916.415,"endTime":921.62,"body":"subjected to, to a treatment that has,"},{"speaker":"Steve Usdin","startTime":921.72,"endTime":925.891,"body":"substantial, you know, or at least has"},{"speaker":"Steve Usdin","startTime":921.72,"endTime":925.891,"body":"some toxicity, some adverse effects."},{"speaker":"Steve Usdin","startTime":926.292,"endTime":931.23,"body":"I don't think that it's really a viable"},{"speaker":"Steve Usdin","startTime":926.292,"endTime":931.23,"body":"standard to say, well, no, you know, this"},{"speaker":"Steve Usdin","startTime":931.263,"endTime":934.066,"body":"do- it looks like it's not gonna hurt"},{"speaker":"Steve Usdin","startTime":931.263,"endTime":934.066,"body":"anybody, so let's just go ahead and try."},{"speaker":"Steve Usdin","startTime":934.099,"endTime":936.335,"body":"Let's go ahead and prove it"},{"speaker":"Steve Usdin","startTime":934.099,"endTime":936.335,"body":"and see, see if it hurts."},{"speaker":"Simone Fishburn","startTime":936.402,"endTime":937.303,"body":"No, I, I agree."},{"speaker":"Simone Fishburn","startTime":937.369,"endTime":938.871,"body":"Although there are plenty"},{"speaker":"Simone Fishburn","startTime":937.369,"endTime":938.871,"body":"of people who would-"},{"speaker":"Steve Usdin","startTime":939.138,"endTime":939.371,"body":"yeah."},{"speaker":"Steve Usdin","startTime":939.371,"endTime":939.605,"body":"I"},{"speaker":"Steve Usdin","startTime":939.605,"endTime":939.872,"body":"d-"},{"speaker":"Simone Fishburn","startTime":939.905,"endTime":940.205,"body":"that is"},{"speaker":"Simone Fishburn","startTime":940.205,"endTime":941.44,"body":"a lot of people who make that argument."},{"speaker":"Simone Fishburn","startTime":941.44,"endTime":942.975,"body":"It's almost a libertarian argument"},{"speaker":"Steve Usdin","startTime":943.208,"endTime":945.878,"body":"I, I don't hold that view,"},{"speaker":"Steve Usdin","startTime":943.208,"endTime":945.878,"body":"and also it happens to not be the law."},{"speaker":"Steve Usdin","startTime":945.878,"endTime":949.348,"body":"The law doesn't say, you know, an"},{"speaker":"Steve Usdin","startTime":945.878,"endTime":949.348,"body":"Alfred E. Neuman \"what me worry\","},{"speaker":"Steve Usdin","startTime":949.448,"endTime":950.916,"body":"kind of standard for approvals."},{"speaker":"Steve Usdin","startTime":950.916,"endTime":955.054,"body":"The, the law says you have to demonstrate,"},{"speaker":"Steve Usdin","startTime":950.916,"endTime":955.054,"body":"um, safety and efficacy, and I, I"},{"speaker":"Steve Usdin","startTime":955.087,"endTime":958.057,"body":"think everybody would, who looks at it"},{"speaker":"Steve Usdin","startTime":955.087,"endTime":958.057,"body":"carefully, would… Not everybody, 'cause"},{"speaker":"Steve Usdin","startTime":958.057,"endTime":961.36,"body":"I, I'm sorry, 'cause there are people"},{"speaker":"Steve Usdin","startTime":958.057,"endTime":961.36,"body":"who, who think, well, if it doesn't"},{"speaker":"Steve Usdin","startTime":961.36,"endTime":964.663,"body":"hurt anybody, just go ahead and do it"},{"speaker":"Steve Usdin","startTime":961.36,"endTime":964.663,"body":"and, let's just approve everything."},{"speaker":"Steve Usdin","startTime":965.097,"endTime":968.3,"body":"I don't think that's a viable,"},{"speaker":"Steve Usdin","startTime":965.097,"endTime":968.3,"body":"standard for FDA going forward, and"},{"speaker":"Steve Usdin","startTime":968.3,"endTime":972.204,"body":"it's certainly not what the advisory"},{"speaker":"Steve Usdin","startTime":968.3,"endTime":972.204,"body":"committee says is happening here."},{"speaker":"Steve Usdin","startTime":972.471,"endTime":976.075,"body":"if it does get approved or if it"},{"speaker":"Steve Usdin","startTime":972.471,"endTime":976.075,"body":"does get accelerated approval, that's"},{"speaker":"Steve Usdin","startTime":976.075,"endTime":977.977,"body":"not what FDA is going to be saying."},{"speaker":"Steve Usdin","startTime":978.143,"endTime":982.448,"body":"The critical thing will be to look at"},{"speaker":"Steve Usdin","startTime":978.143,"endTime":982.448,"body":"the confirmatory trial and the, and the"},{"speaker":"Steve Usdin","startTime":982.448,"endTime":987.086,"body":"experience going forward and to see,"},{"speaker":"Steve Usdin","startTime":982.448,"endTime":987.086,"body":"what happens and, and also to think"},{"speaker":"Steve Usdin","startTime":987.086,"endTime":991.657,"body":"about how to develop policy around"},{"speaker":"Steve Usdin","startTime":987.086,"endTime":991.657,"body":"these issues, around the two things."},{"speaker":"Steve Usdin","startTime":991.69,"endTime":997.696,"body":"One about measuring systemic efficacy,"},{"speaker":"Steve Usdin","startTime":991.69,"endTime":997.696,"body":"and two about, measuring the contributions"},{"speaker":"Steve Usdin","startTime":997.83,"endTime":1000.332,"body":"of two elements of a combination trial."},{"speaker":"Steve Usdin","startTime":1000.699,"endTime":1002.735,"body":"because this isn't the last"},{"speaker":"Steve Usdin","startTime":1000.699,"endTime":1002.735,"body":"time this is gonna come up"},{"speaker":"Selina Koch","startTime":1003.235,"endTime":1006.538,"body":"Now, isn't there"},{"speaker":"Selina Koch","startTime":1003.235,"endTime":1006.538,"body":"already data on Opdivo by itself"},{"speaker":"Selina Koch","startTime":1006.538,"endTime":1010.876,"body":"in this population who's already"},{"speaker":"Selina Koch","startTime":1006.538,"endTime":1010.876,"body":"experienced it before and progressed?"},{"speaker":"Selina Koch","startTime":1010.876,"endTime":1013.946,"body":"And I thought the company's argument"},{"speaker":"Selina Koch","startTime":1010.876,"endTime":1013.946,"body":"was that it was very, very low."},{"speaker":"Selina Koch","startTime":1013.979,"endTime":1018.884,"body":"So whether it's the efficacy of"},{"speaker":"Selina Koch","startTime":1013.979,"endTime":1018.884,"body":"its therapy is FDA's number or its"},{"speaker":"Selina Koch","startTime":1018.884,"endTime":1021.487,"body":"number, both of those are quite"},{"speaker":"Selina Koch","startTime":1018.884,"endTime":1021.487,"body":"higher than Opdivo by itself."},{"speaker":"Selina Koch","startTime":1021.62,"endTime":1024.523,"body":"Did that-- Was that"},{"speaker":"Selina Koch","startTime":1021.62,"endTime":1024.523,"body":"part of the discussion?"},{"speaker":"Steve Usdin","startTime":1024.957,"endTime":1029.695,"body":"Yeah, it is, but that all"},{"speaker":"Steve Usdin","startTime":1024.957,"endTime":1029.695,"body":"depends on the first question of whether"},{"speaker":"Steve Usdin","startTime":1029.695,"endTime":1035.334,"body":"you're using the company's thirty-three"},{"speaker":"Steve Usdin","startTime":1029.695,"endTime":1035.334,"body":"point six percent response rate or FDA's"},{"speaker":"Steve Usdin","startTime":1035.367,"endTime":1038.137,"body":"fifteen point seven percent response rate."},{"speaker":"Steve Usdin","startTime":1038.404,"endTime":1044.243,"body":"So the delta between, um, re-challenge"},{"speaker":"Steve Usdin","startTime":1038.404,"endTime":1044.243,"body":"with, with Opdivo or, or an- another PD-1,"},{"speaker":"Steve Usdin","startTime":1044.276,"endTime":1048.48,"body":"and the effects that we're seeing in this"},{"speaker":"Steve Usdin","startTime":1044.276,"endTime":1048.48,"body":"trial are quite different depending on"},{"speaker":"Steve Usdin","startTime":1048.48,"endTime":1050.783,"body":"which response rate you're, you're using"},{"speaker":"Jeff Cranmer","startTime":1051.85,"endTime":1052.851,"body":"What do you expect, Steve?"},{"speaker":"Steve Usdin","startTime":1053.285,"endTime":1054.987,"body":"Well, I think"},{"speaker":"Steve Usdin","startTime":1053.285,"endTime":1054.987,"body":"we'll know soon enough."},{"speaker":"Steve Usdin","startTime":1055.12,"endTime":1059.024,"body":"I think it would be difficult for"},{"speaker":"Steve Usdin","startTime":1055.12,"endTime":1059.024,"body":"FDA to reject it, to give another,"},{"speaker":"Steve Usdin","startTime":1059.124,"endTime":1063.128,"body":"complete response letter in the face"},{"speaker":"Steve Usdin","startTime":1059.124,"endTime":1063.128,"body":"of a 10 to three advisory committee"},{"speaker":"Steve Usdin","startTime":1063.462,"endTime":1068.167,"body":"vote, uh, in favor and, and also, you"},{"speaker":"Steve Usdin","startTime":1063.462,"endTime":1068.167,"body":"know, be honest, there's a, a lot of"},{"speaker":"Steve Usdin","startTime":1068.167,"endTime":1071.203,"body":"political and, um, and media pressure."},{"speaker":"Steve Usdin","startTime":1071.203,"endTime":1073.539,"body":"I think I've talked about"},{"speaker":"Steve Usdin","startTime":1071.203,"endTime":1073.539,"body":"it on the podcast before."},{"speaker":"Steve Usdin","startTime":1073.539,"endTime":1078.143,"body":"There's been… Besides extraordinary,"},{"speaker":"Steve Usdin","startTime":1073.539,"endTime":1078.143,"body":"uh, media attention to this, there was a,"},{"speaker":"Steve Usdin","startTime":1078.277,"endTime":1084.65,"body":"a meeting that was on the docket between,"},{"speaker":"Steve Usdin","startTime":1078.277,"endTime":1084.65,"body":"political, leadership at FDA, and it"},{"speaker":"Steve Usdin","startTime":1084.65,"endTime":1089.555,"body":"included an attorney from the White House,"},{"speaker":"Steve Usdin","startTime":1084.65,"endTime":1089.555,"body":"which was quite extraordinary, and, the"},{"speaker":"Steve Usdin","startTime":1089.555,"endTime":1094.593,"body":"CEO of, of Replimmun, prior to FDA's"},{"speaker":"Steve Usdin","startTime":1089.555,"endTime":1094.593,"body":"decision to have the advisory committee"},{"speaker":"Steve Usdin","startTime":1094.593,"endTime":1096.495,"body":"and to, to reconsider the application."},{"speaker":"Steve Usdin","startTime":1096.528,"endTime":1100.365,"body":"So, you know, it's obvious that we're"},{"speaker":"Steve Usdin","startTime":1096.528,"endTime":1100.365,"body":"seeing, a lot of pressure from patients."},{"speaker":"Steve Usdin","startTime":1100.365,"endTime":1103.502,"body":"We're seeing, political influence"},{"speaker":"Steve Usdin","startTime":1100.365,"endTime":1103.502,"body":"on this, and now there's the"},{"speaker":"Steve Usdin","startTime":1103.502,"endTime":1104.603,"body":"advisory committee meeting."},{"speaker":"Steve Usdin","startTime":1104.636,"endTime":1108.073,"body":"So Anything could happen, but it"},{"speaker":"Steve Usdin","startTime":1104.636,"endTime":1108.073,"body":"seems to me most likely that, FDA"},{"speaker":"Steve Usdin","startTime":1108.073,"endTime":1109.775,"body":"will grant accelerated approval"},{"speaker":"Jeff Cranmer","startTime":1110.509,"endTime":1110.876,"body":"All right."},{"speaker":"Jeff Cranmer","startTime":1110.876,"endTime":1113.779,"body":"Well, as you said, we'll,"},{"speaker":"Jeff Cranmer","startTime":1110.876,"endTime":1113.779,"body":"we'll know soon enough."},{"speaker":"Jeff Cranmer","startTime":1113.812,"endTime":1119.485,"body":"Uh, we'll take a quick break, and"},{"speaker":"Jeff Cranmer","startTime":1113.812,"endTime":1119.485,"body":"we'll be back to talk psychedelics."},{"speaker":"Voice Talent","startTime":1120.152,"endTime":1123.088,"body":"This episode of BioCentury"},{"speaker":"Voice Talent","startTime":1120.152,"endTime":1123.088,"body":"This Week is brought to you by the"},{"speaker":"Voice Talent","startTime":1123.088,"endTime":1127.659,"body":"13th China Healthcare Summit, taking"},{"speaker":"Voice Talent","startTime":1123.088,"endTime":1127.659,"body":"place November 2nd to 4th in Shanghai"},{"speaker":"Voice Talent","startTime":1129.361,"endTime":1132.931,"body":"Everyone has an opinion about China"},{"speaker":"Voice Talent","startTime":1129.361,"endTime":1132.931,"body":"biotech, but there's a difference"},{"speaker":"Voice Talent","startTime":1132.931,"endTime":1136.468,"body":"between reading about cross-border"},{"speaker":"Voice Talent","startTime":1132.931,"endTime":1136.468,"body":"deals and seeing it for yourself."},{"speaker":"Voice Talent","startTime":1137.035,"endTime":1140.472,"body":"The 13th China Healthcare Summit"},{"speaker":"Voice Talent","startTime":1137.035,"endTime":1140.472,"body":"brings you to Shanghai November"},{"speaker":"Voice Talent","startTime":1140.472,"endTime":1144.443,"body":"2nd to 4th for a firsthand look"},{"speaker":"Voice Talent","startTime":1140.472,"endTime":1144.443,"body":"at China's innovation moment."},{"speaker":"Voice Talent","startTime":1145.01,"endTime":1149.348,"body":"Join BioCentury, BayHelix, and"},{"speaker":"Voice Talent","startTime":1145.01,"endTime":1149.348,"body":"insights partner McKinsey \u0026 Company"},{"speaker":"Voice Talent","startTime":1149.548,"endTime":1154.353,"body":"for a deep dive into China's biopharma"},{"speaker":"Voice Talent","startTime":1149.548,"endTime":1154.353,"body":"ecosystem and meet the biotech leaders"},{"speaker":"Voice Talent","startTime":1154.353,"endTime":1156.155,"body":"who are driving all the newsflow."},{"speaker":"Voice Talent","startTime":1156.622,"endTime":1157.689,"body":"Sourcing innovation."},{"speaker":"Voice Talent","startTime":1157.856,"endTime":1158.891,"body":"Building NewCos."},{"speaker":"Voice Talent","startTime":1159.057,"endTime":1160.993,"body":"Generating faster clinical data."},{"speaker":"Voice Talent","startTime":1161.326,"endTime":1163.595,"body":"Reimagining your R\u0026D strategy."},{"speaker":"Voice Talent","startTime":1164.062,"endTime":1167.766,"body":"For a dozen years, the China Healthcare"},{"speaker":"Voice Talent","startTime":1164.062,"endTime":1167.766,"body":"Summit has gathered the right people"},{"speaker":"Voice Talent","startTime":1167.766,"endTime":1169.535,"body":"to network and build business."},{"speaker":"Voice Talent","startTime":1169.935,"endTime":1172.171,"body":"Now it's your chance to be in the room."},{"speaker":"Voice Talent","startTime":1172.604,"endTime":1174.406,"body":"Join us in Shanghai this November."},{"speaker":"Voice Talent","startTime":1174.64,"endTime":1178.81,"body":"Opt into the tour of Suzhou and a visit"},{"speaker":"Voice Talent","startTime":1174.64,"endTime":1178.81,"body":"to Shanghai clinical trial centers."},{"speaker":"Voice Talent","startTime":1179.144,"endTime":1180.412,"body":"See it for yourself."},{"speaker":"Voice Talent","startTime":1180.846,"endTime":1184.082,"body":"Register at biocenturychinasummit.com."},{"speaker":"Jeff Cranmer","startTime":1186.952,"endTime":1191.823,"body":"Okay, we're back on"},{"speaker":"Jeff Cranmer","startTime":1186.952,"endTime":1191.823,"body":"the BioCentury This Week podcast, and"},{"speaker":"Jeff Cranmer","startTime":1191.823,"endTime":1196.495,"body":"we do hope to see you at the China"},{"speaker":"Jeff Cranmer","startTime":1191.823,"endTime":1196.495,"body":"Healthcare Summit this November."},{"speaker":"Jeff Cranmer","startTime":1196.495,"endTime":1202.267,"body":"It is part of Shanghai Life"},{"speaker":"Jeff Cranmer","startTime":1196.495,"endTime":1202.267,"body":"Sciences Week, for the China Summit."},{"speaker":"Jeff Cranmer","startTime":1202.434,"endTime":1207.773,"body":"it is November 2nd through the 4th,"},{"speaker":"Jeff Cranmer","startTime":1202.434,"endTime":1207.773,"body":"but we have a limited number of"},{"speaker":"Jeff Cranmer","startTime":1207.773,"endTime":1214.78,"body":"spots, remaining for the pre-event"},{"speaker":"Jeff Cranmer","startTime":1207.773,"endTime":1214.78,"body":"excursions, which include a full-day"},{"speaker":"Jeff Cranmer","startTime":1214.78,"endTime":1217.749,"body":"tour at Suzhou's Industrial Park."},{"speaker":"Jeff Cranmer","startTime":1217.749,"endTime":1224.756,"body":"Suzhou, of course, is home to such"},{"speaker":"Jeff Cranmer","startTime":1217.749,"endTime":1224.756,"body":"biotech names as Ascentage, Innovent,"},{"speaker":"Jeff Cranmer","startTime":1224.79,"endTime":1230.829,"body":"Harbour, and Ribo, and it's also where"},{"speaker":"Jeff Cranmer","startTime":1224.79,"endTime":1230.829,"body":"you'll find the campus of BioBay Park."},{"speaker":"Jeff Cranmer","startTime":1231.029,"endTime":1236.235,"body":"we also have a few remaining, slots"},{"speaker":"Jeff Cranmer","startTime":1231.029,"endTime":1236.235,"body":"left for presenting companies."},{"speaker":"Jeff Cranmer","startTime":1236.235,"endTime":1240.505,"body":"We're expecting record attendance"},{"speaker":"Jeff Cranmer","startTime":1236.235,"endTime":1240.505,"body":"from the West this year."},{"speaker":"Jeff Cranmer","startTime":1240.505,"endTime":1245.677,"body":"A lot of very prominent VCs have signed"},{"speaker":"Jeff Cranmer","startTime":1240.505,"endTime":1245.677,"body":"up to join us, and we hope you will too."},{"speaker":"Jeff Cranmer","startTime":1246.111,"endTime":1253.986,"body":"Okay Well, . Late stage wins pharma deals"},{"speaker":"Jeff Cranmer","startTime":1246.111,"endTime":1253.986,"body":"and a relevant commercial precedent have"},{"speaker":"Jeff Cranmer","startTime":1254.052,"endTime":1257.656,"body":"put psychedelics at an inflection point."},{"speaker":"Jeff Cranmer","startTime":1257.923,"endTime":1263.996,"body":"Selina joining us now to talk about"},{"speaker":"Jeff Cranmer","startTime":1257.923,"endTime":1263.996,"body":"what is happening in the world"},{"speaker":"Jeff Cranmer","startTime":1263.996,"endTime":1266.031,"body":"of psychedelics for depression."},{"speaker":"Jeff Cranmer","startTime":1266.265,"endTime":1266.999,"body":"What's up, Selina?"},{"speaker":"Selina Koch","startTime":1267.499,"endTime":1270.869,"body":"Well, I should say our"},{"speaker":"Selina Koch","startTime":1267.499,"endTime":1270.869,"body":"colleague Tierney Baum has put together"},{"speaker":"Selina Koch","startTime":1270.869,"endTime":1274.006,"body":"an analysis, a slide deck, which you"},{"speaker":"Selina Koch","startTime":1270.869,"endTime":1274.006,"body":"will see coming out in BioCentury"},{"speaker":"Selina Koch","startTime":1274.006,"endTime":1280.212,"body":"soon, on psychedelic therapies for"},{"speaker":"Selina Koch","startTime":1274.006,"endTime":1280.212,"body":"depression, in which she, as Steph"},{"speaker":"Selina Koch","startTime":1280.212,"endTime":1284.716,"body":"just mentioned, argues there's a number"},{"speaker":"Selina Koch","startTime":1280.212,"endTime":1284.716,"body":"of factors sort of lining up to move"},{"speaker":"Selina Koch","startTime":1284.716,"endTime":1286.318,"body":"that field toward an inflection point."},{"speaker":"Selina Koch","startTime":1287.286,"endTime":1290.122,"body":"when it comes to the deal,"},{"speaker":"Selina Koch","startTime":1287.286,"endTime":1290.122,"body":"the deal's part of that."},{"speaker":"Selina Koch","startTime":1290.289,"endTime":1297.229,"body":"We saw Eli Lilly last month agree to buy"},{"speaker":"Selina Koch","startTime":1290.289,"endTime":1297.229,"body":"AtaiBeckley for about $3 billion upfront."},{"speaker":"Selina Koch","startTime":1297.696,"endTime":1301.4,"body":"of course, last year we saw AbbVie"},{"speaker":"Selina Koch","startTime":1297.696,"endTime":1301.4,"body":"buy, um, the lead candidate of"},{"speaker":"Selina Koch","startTime":1301.433,"endTime":1306.738,"body":"Gilgamesh, and it's-- Utsuka had"},{"speaker":"Selina Koch","startTime":1301.433,"endTime":1306.738,"body":"also done, an acquisition this year."},{"speaker":"Selina Koch","startTime":1306.738,"endTime":1309.474,"body":"So kind of pharmas are showing interest."},{"speaker":"Selina Koch","startTime":1309.775,"endTime":1313.312,"body":"The pipeline is maturing."},{"speaker":"Selina Koch","startTime":1313.712,"endTime":1319.618,"body":"So Compass Pathways has two positive"},{"speaker":"Selina Koch","startTime":1313.712,"endTime":1319.618,"body":"Phase III trials and, expects to complete"},{"speaker":"Selina Koch","startTime":1319.618,"endTime":1321.586,"body":"its rolling submission this year."},{"speaker":"Selina Koch","startTime":1321.586,"endTime":1325.457,"body":"So next year could bring the"},{"speaker":"Selina Koch","startTime":1321.586,"endTime":1325.457,"body":"first approval of a classic"},{"speaker":"Selina Koch","startTime":1325.457,"endTime":1327.092,"body":"psychedelic for depression."},{"speaker":"Selina Koch","startTime":1327.359,"endTime":1330.362,"body":"Behind it, there's an"},{"speaker":"Selina Koch","startTime":1327.359,"endTime":1330.362,"body":"11-member clinical pipeline."},{"speaker":"Simone Fishburn","startTime":1331.73,"endTime":1335.567,"body":"Selina, you know, this"},{"speaker":"Simone Fishburn","startTime":1331.73,"endTime":1335.567,"body":"space, it, it's one of those ones that was"},{"speaker":"Simone Fishburn","startTime":1335.567,"endTime":1339.538,"body":"sort of, trundling along and then sort of,"},{"speaker":"Simone Fishburn","startTime":1335.567,"endTime":1339.538,"body":"kind of has exploded in the last couple"},{"speaker":"Simone Fishburn","startTime":1339.538,"endTime":1341.74,"body":"of years maybe, maybe less than that."},{"speaker":"Simone Fishburn","startTime":1342.341,"endTime":1344.509,"body":"you talk about an inflection point."},{"speaker":"Simone Fishburn","startTime":1345.077,"endTime":1346.978,"body":"What could the trajectory look like?"},{"speaker":"Simone Fishburn","startTime":1346.978,"endTime":1349.381,"body":"I mean, it seems that obviously"},{"speaker":"Simone Fishburn","startTime":1346.978,"endTime":1349.381,"body":"it's become very mainstream."},{"speaker":"Simone Fishburn","startTime":1349.381,"endTime":1353.552,"body":"We've got a number of pharmas, you said"},{"speaker":"Simone Fishburn","startTime":1349.381,"endTime":1353.552,"body":"Eli Lilly,  getting in the game as well."},{"speaker":"Simone Fishburn","startTime":1353.552,"endTime":1356.855,"body":"Although with Lilly, you don't know"},{"speaker":"Simone Fishburn","startTime":1353.552,"endTime":1356.855,"body":"whether they just have so many resources"},{"speaker":"Simone Fishburn","startTime":1356.855,"endTime":1359.324,"body":"now that they're just gonna cover"},{"speaker":"Simone Fishburn","startTime":1356.855,"endTime":1359.324,"body":"every base just in case, and they"},{"speaker":"Simone Fishburn","startTime":1359.324,"endTime":1360.759,"body":"can afford to do that and then win."},{"speaker":"Simone Fishburn","startTime":1361.026,"endTime":1363.962,"body":"So, so I'm not sure how much"},{"speaker":"Simone Fishburn","startTime":1361.026,"endTime":1363.962,"body":"that means for the field that,"},{"speaker":"Simone Fishburn","startTime":1363.962,"endTime":1365.197,"body":"that Eli Lilly has bought in."},{"speaker":"Simone Fishburn","startTime":1365.197,"endTime":1367.399,"body":"It's not like they spent"},{"speaker":"Simone Fishburn","startTime":1365.197,"endTime":1367.399,"body":"their last dime on it, right?"},{"speaker":"Selina Koch","startTime":1367.733,"endTime":1368.533,"body":"I agree with that."},{"speaker":"Selina Koch","startTime":1368.6,"endTime":1369.167,"body":"Yeah."},{"speaker":"Selina Koch","startTime":1369.334,"endTime":1369.668,"body":"Yeah"},{"speaker":"Simone Fishburn","startTime":1369.835,"endTime":1371.937,"body":"so, so,"},{"speaker":"Simone Fishburn","startTime":1369.835,"endTime":1371.937,"body":"but what would it look like?"},{"speaker":"Simone Fishburn","startTime":1371.937,"endTime":1376.141,"body":"I mean, do you think from a treatment"},{"speaker":"Simone Fishburn","startTime":1371.937,"endTime":1376.141,"body":"perspective, how big could this field be?"},{"speaker":"Simone Fishburn","startTime":1376.375,"endTime":1381.38,"body":"Do, do you think it could really change"},{"speaker":"Simone Fishburn","startTime":1376.375,"endTime":1381.38,"body":"the whole field of, of, of psych,"},{"speaker":"Simone Fishburn","startTime":1381.546,"endTime":1386.485,"body":"or do you think it will always be"},{"speaker":"Simone Fishburn","startTime":1381.546,"endTime":1386.485,"body":"sort of hampered by the constraints"},{"speaker":"Simone Fishburn","startTime":1386.485,"endTime":1391.289,"body":"of how you can deliver it and, and,"},{"speaker":"Simone Fishburn","startTime":1386.485,"endTime":1391.289,"body":"and its sort of negative, potential?"},{"speaker":"Selina Koch","startTime":1392.891,"endTime":1394.159,"body":"there's a"},{"speaker":"Selina Koch","startTime":1392.891,"endTime":1394.159,"body":"couple pieces to that."},{"speaker":"Selina Koch","startTime":1394.259,"endTime":1396.328,"body":"One is effect size."},{"speaker":"Selina Koch","startTime":1396.361,"endTime":1398.23,"body":"What does it actually do for the patient?"},{"speaker":"Selina Koch","startTime":1398.33,"endTime":1401.566,"body":"And then the other is the scalability"},{"speaker":"Selina Koch","startTime":1398.33,"endTime":1401.566,"body":"issues, the commercial model, right?"},{"speaker":"Selina Koch","startTime":1402.0,"endTime":1407.539,"body":"So on scalability, the, that precedent,"},{"speaker":"Selina Koch","startTime":1402.0,"endTime":1407.539,"body":"the commercial precedent that Jeff alluded"},{"speaker":"Selina Koch","startTime":1407.539,"endTime":1413.178,"body":"to, that's from Johnson \u0026 Johnson's"},{"speaker":"Selina Koch","startTime":1407.539,"endTime":1413.178,"body":"Spravato, which is a S-enantiomer, a"},{"speaker":"Selina Koch","startTime":1413.178,"endTime":1414.98,"body":"left-handed version of, of ketamine."},{"speaker":"Selina Koch","startTime":1415.58,"endTime":1420.218,"body":"So ketamine is not a classic psychedelic,"},{"speaker":"Selina Koch","startTime":1415.58,"endTime":1420.218,"body":"but it's psychedelic adjacent in"},{"speaker":"Selina Koch","startTime":1420.218,"endTime":1423.889,"body":"the sense that it's a highly psyc-"},{"speaker":"Selina Koch","startTime":1420.218,"endTime":1423.889,"body":"psychoactive compound, and it requires,"},{"speaker":"Selina Koch","startTime":1424.256,"endTime":1429.461,"body":"administration in a clinic and then"},{"speaker":"Selina Koch","startTime":1424.256,"endTime":1429.461,"body":"monitoring during that psychoactive"},{"speaker":"Selina Koch","startTime":1429.594,"endTime":1432.964,"body":"experience, before a, a discharge, right?"},{"speaker":"Selina Koch","startTime":1432.964,"endTime":1437.202,"body":"And so psychedelics, psilocybin and"},{"speaker":"Selina Koch","startTime":1432.964,"endTime":1437.202,"body":"LSD are gonna require that as well."},{"speaker":"Selina Koch","startTime":1437.235,"endTime":1438.57,"body":"So it's a very different model."},{"speaker":"Selina Koch","startTime":1438.57,"endTime":1444.342,"body":"It uses clinic resources that you"},{"speaker":"Selina Koch","startTime":1438.57,"endTime":1444.342,"body":"would not use from like a Zoloft type,"},{"speaker":"Selina Koch","startTime":1444.476,"endTime":1446.344,"body":"you know, take-at-home pill, right?"},{"speaker":"Selina Koch","startTime":1446.812,"endTime":1451.516,"body":"Um, different kinds of billing models,"},{"speaker":"Selina Koch","startTime":1446.812,"endTime":1451.516,"body":"staff, equipment, so on and so forth."},{"speaker":"Selina Koch","startTime":1451.983,"endTime":1457.289,"body":"But J\u0026J, it had a very-- a fairly"},{"speaker":"Selina Koch","startTime":1451.983,"endTime":1457.289,"body":"slow launch for, for Spravato,"},{"speaker":"Selina Koch","startTime":1457.289,"endTime":1459.324,"body":"but it, is winning that battle."},{"speaker":"Selina Koch","startTime":1459.391,"endTime":1461.493,"body":"It's now a blockbuster drug."},{"speaker":"Selina Koch","startTime":1461.493,"endTime":1464.262,"body":"Might even reach two"},{"speaker":"Selina Koch","startTime":1461.493,"endTime":1464.262,"body":"billion, in the near future."},{"speaker":"Selina Koch","startTime":1464.696,"endTime":1470.435,"body":"And to do that, it has got, I think"},{"speaker":"Selina Koch","startTime":1464.696,"endTime":1470.435,"body":"it's over seven thousand now certified"},{"speaker":"Selina Koch","startTime":1470.435,"endTime":1472.771,"body":"clinics that can deliver this care."},{"speaker":"Selina Koch","startTime":1473.205,"endTime":1478.577,"body":"And so the next generation companies,"},{"speaker":"Selina Koch","startTime":1473.205,"endTime":1478.577,"body":"basically they plan to piggyback on"},{"speaker":"Selina Koch","startTime":1478.577,"endTime":1482.247,"body":"this network that J\u0026J has already"},{"speaker":"Selina Koch","startTime":1478.577,"endTime":1482.247,"body":"built and then hopefully also"},{"speaker":"Selina Koch","startTime":1482.28,"endTime":1483.849,"body":"build it out some more themselves."},{"speaker":"Selina Koch","startTime":1484.583,"endTime":1485.917,"body":"So that's on the scalability side."},{"speaker":"Selina Koch","startTime":1485.917,"endTime":1491.323,"body":"In terms of what it does for patients,"},{"speaker":"Selina Koch","startTime":1485.917,"endTime":1491.323,"body":"I mean, we have-- there's a fair bit of"},{"speaker":"Selina Koch","startTime":1491.49,"endTime":1495.994,"body":"early clinical stage data now, and there's"},{"speaker":"Selina Koch","startTime":1491.49,"endTime":1495.994,"body":"starting to be some late-stage readouts."},{"speaker":"Selina Koch","startTime":1495.994,"endTime":1499.164,"body":"And so Compass Pathways, as"},{"speaker":"Selina Koch","startTime":1495.994,"endTime":1499.164,"body":"I mentioned, is a leader."},{"speaker":"Selina Koch","startTime":1499.164,"endTime":1502.501,"body":"They've had two phase III"},{"speaker":"Selina Koch","startTime":1499.164,"endTime":1502.501,"body":"trials they produced an effect."},{"speaker":"Selina Koch","startTime":1502.534,"endTime":1507.239,"body":"It w-- They both were positive, so it's"},{"speaker":"Selina Koch","startTime":1502.534,"endTime":1507.239,"body":"reproducible, so it seems to be real."},{"speaker":"Selina Koch","startTime":1507.572,"endTime":1509.708,"body":"it's not an especially big effect."},{"speaker":"Selina Koch","startTime":1509.708,"endTime":1513.678,"body":"It's in the range of your conventional"},{"speaker":"Selina Koch","startTime":1509.708,"endTime":1513.678,"body":"antidepressants, you know, and"},{"speaker":"Selina Koch","startTime":1513.678,"endTime":1516.781,"body":"there's been so many trials in"},{"speaker":"Selina Koch","startTime":1513.678,"endTime":1516.781,"body":"antidepressants over the decades."},{"speaker":"Selina Koch","startTime":1517.449,"endTime":1520.485,"body":"Sort of the, the effect on the"},{"speaker":"Selina Koch","startTime":1517.449,"endTime":1520.485,"body":"primary endpoint, which is like"},{"speaker":"Selina Koch","startTime":1520.519,"endTime":1524.756,"body":"the typical scale of depression"},{"speaker":"Selina Koch","startTime":1520.519,"endTime":1524.756,"body":"symptoms, is called the MADRS."},{"speaker":"Selina Koch","startTime":1525.29,"endTime":1527.792,"body":"In its two phase III trials, it"},{"speaker":"Selina Koch","startTime":1525.29,"endTime":1527.792,"body":"produced, you know, three point"},{"speaker":"Selina Koch","startTime":1527.792,"endTime":1532.13,"body":"six, three point eight  point"},{"speaker":"Selina Koch","startTime":1527.792,"endTime":1532.13,"body":"changes on that sixty-point scale."},{"speaker":"Selina Koch","startTime":1532.797,"endTime":1535.333,"body":"so your classic psychedelics"},{"speaker":"Selina Koch","startTime":1532.797,"endTime":1535.333,"body":"are around that."},{"speaker":"Selina Koch","startTime":1535.6,"endTime":1541.273,"body":"Spravato in its one, like, positive"},{"speaker":"Selina Koch","startTime":1535.6,"endTime":1541.273,"body":"pivotal trial produced something"},{"speaker":"Selina Koch","startTime":1541.273,"endTime":1542.741,"body":"similar to that, about four points."},{"speaker":"Selina Koch","startTime":1543.174,"endTime":1548.413,"body":"So it will be-- it's looking like they're"},{"speaker":"Selina Koch","startTime":1543.174,"endTime":1548.413,"body":"gonna be another treatment option that's"},{"speaker":"Selina Koch","startTime":1560.325,"endTime":1561.259,"body":"Effective that patients can turn to."},{"speaker":"Selina Koch","startTime":1561.259,"endTime":1561.293,"body":"Will they prefer it?"},{"speaker":"Selina Koch","startTime":1561.293,"endTime":1561.326,"body":"It remains to be seen."},{"speaker":"Selina Koch","startTime":1561.326,"endTime":1561.459,"body":"There, there is this, um… From"},{"speaker":"Selina Koch","startTime":1561.326,"endTime":1561.459,"body":"the trials we've seen, they do"},{"speaker":"Selina Koch","startTime":1561.459,"endTime":1564.496,"body":"seem-- the effect seems to be,"},{"speaker":"Selina Koch","startTime":1561.459,"endTime":1564.496,"body":"measurable quickly, within days,"},{"speaker":"Selina Koch","startTime":1564.729,"endTime":1566.698,"body":"and then they're burdensome, right?"},{"speaker":"Selina Koch","startTime":1566.698,"endTime":1569.634,"body":"'Cause you have to go into the"},{"speaker":"Selina Koch","startTime":1566.698,"endTime":1569.634,"body":"clinic and take a day off work."},{"speaker":"Selina Koch","startTime":1570.201,"endTime":1572.404,"body":"but you don't have to"},{"speaker":"Selina Koch","startTime":1570.201,"endTime":1572.404,"body":"get dosed very often."},{"speaker":"Selina Koch","startTime":1572.971,"endTime":1576.608,"body":"So these are the trade-offs"},{"speaker":"Selina Koch","startTime":1572.971,"endTime":1576.608,"body":"that physicians, and patients"},{"speaker":"Selina Koch","startTime":1576.608,"endTime":1577.809,"body":"will have to consider"},{"speaker":"Simone Fishburn","startTime":1578.209,"endTime":1578.677,"body":"Right."},{"speaker":"Simone Fishburn","startTime":1578.71,"endTime":1582.247,"body":"So do you, I mean, are we"},{"speaker":"Simone Fishburn","startTime":1578.71,"endTime":1582.247,"body":"seeing,  a growth of the pipeline"},{"speaker":"Simone Fishburn","startTime":1582.247,"endTime":1583.915,"body":"in a, in a significant way?"},{"speaker":"Simone Fishburn","startTime":1583.915,"endTime":1588.086,"body":"Are we sort of seeing it all the way down"},{"speaker":"Simone Fishburn","startTime":1583.915,"endTime":1588.086,"body":"at the innovation end, the discovery end?"},{"speaker":"Simone Fishburn","startTime":1588.086,"endTime":1590.488,"body":"Is it, is it sort of really"},{"speaker":"Simone Fishburn","startTime":1588.086,"endTime":1590.488,"body":"filling out at lots of levels?"},{"speaker":"Selina Koch","startTime":1591.256,"endTime":1592.524,"body":"Well, here's the thing."},{"speaker":"Selina Koch","startTime":1592.857,"endTime":1595.66,"body":"Nobody really knows how"},{"speaker":"Selina Koch","startTime":1592.857,"endTime":1595.66,"body":"psychedelics work, right?"},{"speaker":"Selina Koch","startTime":1595.961,"endTime":1598.863,"body":"This is not hypothesis-driven"},{"speaker":"Selina Koch","startTime":1595.961,"endTime":1598.863,"body":"science exactly."},{"speaker":"Selina Koch","startTime":1599.297,"endTime":1603.134,"body":"Um, like, like, like we've cracked"},{"speaker":"Selina Koch","startTime":1599.297,"endTime":1603.134,"body":"brain science, so we know what causes"},{"speaker":"Selina Koch","startTime":1603.134,"endTime":1606.905,"body":"depression, and now we have a very,"},{"speaker":"Selina Koch","startTime":1603.134,"endTime":1606.905,"body":"you know, specific targeted therapy"},{"speaker":"Selina Koch","startTime":1606.905,"endTime":1608.673,"body":"against that mechan- it's not like that."},{"speaker":"Selina Koch","startTime":1609.14,"endTime":1610.175,"body":"I always think of them as more"},{"speaker":"Jeff Cranmer","startTime":1610.175,"endTime":1612.944,"body":"despite a lot of"},{"speaker":"Jeff Cranmer","startTime":1610.175,"endTime":1612.944,"body":"research being done, uh, in San"},{"speaker":"Jeff Cranmer","startTime":1612.944,"endTime":1615.18,"body":"Francisco from the late '60s on"},{"speaker":"Selina Koch","startTime":1616.281,"endTime":1616.948,"body":"Yeah, right."},{"speaker":"Selina Koch","startTime":1616.982,"endTime":1619.918,"body":"A lot of research on,"},{"speaker":"Selina Koch","startTime":1616.982,"endTime":1619.918,"body":"on themselves, people."},{"speaker":"Selina Koch","startTime":1619.951,"endTime":1625.991,"body":"But, um, so there is a, the, the leading"},{"speaker":"Selina Koch","startTime":1619.951,"endTime":1625.991,"body":"hypothesis has to do with a certain"},{"speaker":"Selina Koch","startTime":1625.991,"endTime":1630.462,"body":"type of serotonin receptor, 5-HT2A."},{"speaker":"Selina Koch","startTime":1630.962,"endTime":1635.867,"body":"for those in the camp who believe that"},{"speaker":"Selina Koch","startTime":1630.962,"endTime":1635.867,"body":"the psychedelic experience itself, getting"},{"speaker":"Selina Koch","startTime":1635.867,"endTime":1642.04,"body":"out of your mind, is key, they think that"},{"speaker":"Selina Koch","startTime":1635.867,"endTime":1642.04,"body":"that mostly is driven through 5-HT2A."},{"speaker":"Selina Koch","startTime":1642.04,"endTime":1647.212,"body":"But these compounds from LSD"},{"speaker":"Selina Koch","startTime":1642.04,"endTime":1647.212,"body":"and, and psilocybin, they, they"},{"speaker":"Selina Koch","startTime":1647.212,"endTime":1649.214,"body":"bind a wide range of receptors."},{"speaker":"Selina Koch","startTime":1649.714,"endTime":1653.752,"body":"Um, the serotonin system, LSD"},{"speaker":"Selina Koch","startTime":1649.714,"endTime":1653.752,"body":"also, and the dopamine system."},{"speaker":"Selina Koch","startTime":1654.252,"endTime":1658.39,"body":"It, it gets more complex from"},{"speaker":"Selina Koch","startTime":1654.252,"endTime":1658.39,"body":"there, and these receptors can be"},{"speaker":"Selina Koch","startTime":1658.39,"endTime":1660.625,"body":"found all over the brain, right?"},{"speaker":"Selina Koch","startTime":1660.659,"endTime":1664.396,"body":"So you're having different effects"},{"speaker":"Selina Koch","startTime":1660.659,"endTime":1664.396,"body":"in different places on different"},{"speaker":"Selina Koch","startTime":1664.396,"endTime":1667.465,"body":"timescales, and sorting that"},{"speaker":"Selina Koch","startTime":1664.396,"endTime":1667.465,"body":"all out is not at all trivial."},{"speaker":"Selina Koch","startTime":1667.866,"endTime":1671.77,"body":"so when you say on the innovation"},{"speaker":"Selina Koch","startTime":1667.866,"endTime":1671.77,"body":"end, I mean, I think not included in"},{"speaker":"Selina Koch","startTime":1671.87,"endTime":1676.341,"body":"Tierney's analysis here, but there is"},{"speaker":"Selina Koch","startTime":1671.87,"endTime":1676.341,"body":"a set of companies who think they can"},{"speaker":"Selina Koch","startTime":1676.808,"endTime":1681.112,"body":"achieve a similar sort of efficacy"},{"speaker":"Selina Koch","startTime":1676.808,"endTime":1681.112,"body":"without the psychoactive piece."},{"speaker":"Selina Koch","startTime":1681.146,"endTime":1685.684,"body":"And I would say they're trying to"},{"speaker":"Selina Koch","startTime":1681.146,"endTime":1685.684,"body":"get to a more specific targeted"},{"speaker":"Selina Koch","startTime":1685.684,"endTime":1689.721,"body":"mechanism But, you know, that's a"},{"speaker":"Selina Koch","startTime":1685.684,"endTime":1689.721,"body":"small, that's a small set of companies"},{"speaker":"Simone Fishburn","startTime":1691.089,"endTime":1696.194,"body":"I think it's just really"},{"speaker":"Simone Fishburn","startTime":1691.089,"endTime":1696.194,"body":"difficult because, because, I don't know,"},{"speaker":"Simone Fishburn","startTime":1696.194,"endTime":1698.063,"body":"they, um, it's just a difficult field."},{"speaker":"Simone Fishburn","startTime":1698.063,"endTime":1699.664,"body":"M- m- maybe because of what you said."},{"speaker":"Simone Fishburn","startTime":1699.931,"endTime":1702.734,"body":"It's like the science behind it is"},{"speaker":"Simone Fishburn","startTime":1703.034,"endTime":1704.369,"body":"amorphous, shall we say."},{"speaker":"Selina Koch","startTime":1704.936,"endTime":1705.704,"body":"Totally"},{"speaker":"Selina Koch","startTime":1706.104,"endTime":1709.708,"body":"I mean, I think of it, the"},{"speaker":"Selina Koch","startTime":1706.104,"endTime":1709.708,"body":"mechanistically, this is probably,"},{"speaker":"Selina Koch","startTime":1709.774,"endTime":1710.975,"body":"they would probably reject this."},{"speaker":"Selina Koch","startTime":1710.975,"endTime":1712.944,"body":"I think of it like electroconvulsive shock"},{"speaker":"Simone Fishburn","startTime":1713.144,"endTime":1714.412,"body":"It is"},{"speaker":"Simone Fishburn","startTime":1713.144,"endTime":1714.412,"body":"something like that."},{"speaker":"Simone Fishburn","startTime":1714.446,"endTime":1714.579,"body":"I"},{"speaker":"Selina Koch","startTime":1714.913,"endTime":1717.749,"body":"Like you just jolt the"},{"speaker":"Selina Koch","startTime":1714.913,"endTime":1717.749,"body":"brain out of a local minima, you"},{"speaker":"Selina Koch","startTime":1717.749,"endTime":1721.052,"body":"break a negative feedback loop, and"},{"speaker":"Selina Koch","startTime":1717.749,"endTime":1721.052,"body":"when it settles back down, maybe you"},{"speaker":"Selina Koch","startTime":1721.052,"endTime":1722.554,"body":"have a chance of, you know"},{"speaker":"Simone Fishburn","startTime":1722.921,"endTime":1724.489,"body":"No,"},{"speaker":"Simone Fishburn","startTime":1722.921,"endTime":1724.489,"body":"I, I, I agree with you."},{"speaker":"Simone Fishburn","startTime":1724.489,"endTime":1727.792,"body":"And it's funny because, like…"},{"speaker":"Simone Fishburn","startTime":1724.489,"endTime":1727.792,"body":"So I'm a molecular pharmacologist."},{"speaker":"Simone Fishburn","startTime":1727.792,"endTime":1730.428,"body":"I'm not a systems biologist, right?"},{"speaker":"Simone Fishburn","startTime":1730.762,"endTime":1734.032,"body":"And so I tend to think in"},{"speaker":"Simone Fishburn","startTime":1730.762,"endTime":1734.032,"body":"terms of pathways, right?"},{"speaker":"Simone Fishburn","startTime":1734.065,"endTime":1738.269,"body":"Rather than, you know, rather"},{"speaker":"Simone Fishburn","startTime":1734.065,"endTime":1738.269,"body":"than that sort of reset that"},{"speaker":"Simone Fishburn","startTime":1738.269,"endTime":1739.504,"body":"you're just talking about."},{"speaker":"Simone Fishburn","startTime":1740.038,"endTime":1741.84,"body":"you were talking about there's"},{"speaker":"Simone Fishburn","startTime":1740.038,"endTime":1741.84,"body":"all these inputs and whatever."},{"speaker":"Simone Fishburn","startTime":1742.307,"endTime":1744.676,"body":"You would really think that"},{"speaker":"Simone Fishburn","startTime":1742.307,"endTime":1744.676,"body":"you could feed that in."},{"speaker":"Simone Fishburn","startTime":1744.676,"endTime":1747.445,"body":"That's the kind of information"},{"speaker":"Simone Fishburn","startTime":1744.676,"endTime":1747.445,"body":"you'd imagine that AI should"},{"speaker":"Simone Fishburn","startTime":1747.479,"endTime":1748.48,"body":"be able to pick through."},{"speaker":"Simone Fishburn","startTime":1748.947,"endTime":1752.517,"body":"If you actually could give it reliable"},{"speaker":"Simone Fishburn","startTime":1748.947,"endTime":1752.517,"body":"information, I think one of the problems"},{"speaker":"Simone Fishburn","startTime":1752.517,"endTime":1758.223,"body":"with psychedelics is there haven't been"},{"speaker":"Simone Fishburn","startTime":1752.517,"endTime":1758.223,"body":"that many well-controlled studies, right?"},{"speaker":"Simone Fishburn","startTime":1758.256,"endTime":1761.426,"body":"So as Jeff says, half of it is"},{"speaker":"Simone Fishburn","startTime":1758.256,"endTime":1761.426,"body":"being done in, you know, Hey,"},{"speaker":"Simone Fishburn","startTime":1761.459,"endTime":1766.164,"body":"Ashby, as opposed to ways that you"},{"speaker":"Simone Fishburn","startTime":1761.459,"endTime":1766.164,"body":"can really get the data in the…"},{"speaker":"Simone Fishburn","startTime":1766.898,"endTime":1769.334,"body":"So, but what I'm saying is that"},{"speaker":"Simone Fishburn","startTime":1766.898,"endTime":1769.334,"body":"doesn't mean it's not real."},{"speaker":"Simone Fishburn","startTime":1769.334,"endTime":1772.504,"body":"It just means it's very hard for"},{"speaker":"Simone Fishburn","startTime":1769.334,"endTime":1772.504,"body":"people who have got my training"},{"speaker":"Simone Fishburn","startTime":1772.737,"endTime":1773.805,"body":"to get their head around,"},{"speaker":"Selina Koch","startTime":1774.739,"endTime":1774.973,"body":"Yeah."},{"speaker":"Selina Koch","startTime":1774.973,"endTime":1779.344,"body":"In some ways it's like back to an"},{"speaker":"Selina Koch","startTime":1774.973,"endTime":1779.344,"body":"older school kind of medicine where"},{"speaker":"Selina Koch","startTime":1779.344,"endTime":1782.68,"body":"you tried stuff and you don't, didn't"},{"speaker":"Selina Koch","startTime":1779.344,"endTime":1782.68,"body":"know why it worked or whatever."},{"speaker":"Selina Koch","startTime":1782.68,"endTime":1786.518,"body":"But like the way that the industry is"},{"speaker":"Selina Koch","startTime":1782.68,"endTime":1786.518,"body":"moving is, you know, targeted therapy,"},{"speaker":"Selina Koch","startTime":1786.618,"endTime":1789.254,"body":"like understood, like, uh, causal biology."},{"speaker":"Selina Koch","startTime":1789.254,"endTime":1790.321,"body":"You know, this is very different"},{"speaker":"Simone Fishburn","startTime":1790.722,"endTime":1794.726,"body":"But like Bayer"},{"speaker":"Simone Fishburn","startTime":1790.722,"endTime":1794.726,"body":"developed aspirin in something like 1915."},{"speaker":"Simone Fishburn","startTime":1794.726,"endTime":1798.363,"body":"It was like 80 years before they"},{"speaker":"Simone Fishburn","startTime":1794.726,"endTime":1798.363,"body":"knew how aspirin worked, right?"},{"speaker":"Simone Fishburn","startTime":1798.73,"endTime":1802.867,"body":"And nobody questions that aspirin"},{"speaker":"Simone Fishburn","startTime":1798.73,"endTime":1802.867,"body":"works or even how it works now."},{"speaker":"Jeff Cranmer","startTime":1803.902,"endTime":1805.403,"body":"Very interesting stuff."},{"speaker":"Jeff Cranmer","startTime":1805.436,"endTime":1808.54,"body":"Tierney, uh, has definitely"},{"speaker":"Jeff Cranmer","startTime":1805.436,"endTime":1808.54,"body":"dug deep this time."},{"speaker":"Jeff Cranmer","startTime":1808.54,"endTime":1810.542,"body":"The deck, uh, love the format."},{"speaker":"Jeff Cranmer","startTime":1810.608,"endTime":1816.314,"body":"It, it just, uh, gets all the info,"},{"speaker":"Jeff Cranmer","startTime":1810.608,"endTime":1816.314,"body":"to the readers front and center."},{"speaker":"Jeff Cranmer","startTime":1816.581,"endTime":1821.186,"body":"I guess one, one last thing that's"},{"speaker":"Jeff Cranmer","startTime":1816.581,"endTime":1821.186,"body":"probably worth mentioning, Selina, is,"},{"speaker":"Jeff Cranmer","startTime":1821.186,"endTime":1829.194,"body":"uh, psychedelics have, have been kind"},{"speaker":"Jeff Cranmer","startTime":1821.186,"endTime":1829.194,"body":"of championed by HHS, in recent years."},{"speaker":"Jeff Cranmer","startTime":1829.194,"endTime":1829.694,"body":"Uh,"},{"speaker":"Simone Fishburn","startTime":1830.028,"endTime":1831.429,"body":"anyone"},{"speaker":"Simone Fishburn","startTime":1830.028,"endTime":1831.429,"body":"in particular at HHS?"},{"speaker":"Jeff Cranmer","startTime":1832.73,"endTime":1835.733,"body":"Last seen with"},{"speaker":"Jeff Cranmer","startTime":1832.73,"endTime":1835.733,"body":"a whale on top of his car."},{"speaker":"Jeff Cranmer","startTime":1839.237,"endTime":1843.241,"body":"Um, yeah, so any, any comments"},{"speaker":"Jeff Cranmer","startTime":1839.237,"endTime":1843.241,"body":"on the impact of, of this"},{"speaker":"Jeff Cranmer","startTime":1843.241,"endTime":1846.077,"body":"federal push by, uh, RFK Jr.?"},{"speaker":"Selina Koch","startTime":1846.911,"endTime":1848.379,"body":"Well, there's"},{"speaker":"Selina Koch","startTime":1846.911,"endTime":1848.379,"body":"a few threads to it."},{"speaker":"Selina Koch","startTime":1848.379,"endTime":1851.716,"body":"I think there's an execu-- there"},{"speaker":"Selina Koch","startTime":1848.379,"endTime":1851.716,"body":"was an executive order in April"},{"speaker":"Selina Koch","startTime":1852.05,"endTime":1856.855,"body":"that instructed HHS to kind of"},{"speaker":"Selina Koch","startTime":1852.05,"endTime":1856.855,"body":"accelerate access to these treatments."},{"speaker":"Selina Koch","startTime":1857.355,"endTime":1862.827,"body":"And then there were, back when Makary was"},{"speaker":"Selina Koch","startTime":1857.355,"endTime":1862.827,"body":"still FDA commissioner, um, commissioners"},{"speaker":"Selina Koch","startTime":1862.861,"endTime":1867.031,"body":"national priority review vouchers"},{"speaker":"Selina Koch","startTime":1862.861,"endTime":1867.031,"body":"given to a few of the leaders in the"},{"speaker":"Selina Koch","startTime":1867.031,"endTime":1871.903,"body":"space, which, you know, could m-move"},{"speaker":"Selina Koch","startTime":1867.031,"endTime":1871.903,"body":"their reviews ahead, uh, shorten them."},{"speaker":"Selina Koch","startTime":1872.337,"endTime":1878.142,"body":"And then there's some-- That executive"},{"speaker":"Selina Koch","startTime":1872.337,"endTime":1878.142,"body":"order also, is trying to lower barriers"},{"speaker":"Selina Koch","startTime":1878.142,"endTime":1883.114,"body":"to research through rescheduling"},{"speaker":"Selina Koch","startTime":1878.142,"endTime":1883.114,"body":"of these for research purposes."},{"speaker":"Selina Koch","startTime":1883.615,"endTime":1888.186,"body":"Now, there's still more to do on that"},{"speaker":"Selina Koch","startTime":1883.615,"endTime":1888.186,"body":"front when one actually gets approved,"},{"speaker":"Selina Koch","startTime":1888.62,"endTime":1890.455,"body":"in terms of, like, fully rescheduling."},{"speaker":"Selina Koch","startTime":1890.788,"endTime":1892.724,"body":"So that's still, that's still an overhang"},{"speaker":"Jeff Cranmer","startTime":1893.558,"endTime":1894.092,"body":"Okay."},{"speaker":"Jeff Cranmer","startTime":1894.092,"endTime":1895.126,"body":"Well, thanks for that."},{"speaker":"Jeff Cranmer","startTime":1895.226,"endTime":1897.328,"body":"look for the link in the show notes."},{"speaker":"Jeff Cranmer","startTime":1897.729,"endTime":1900.832,"body":"And while you're there,"},{"speaker":"Jeff Cranmer","startTime":1897.729,"endTime":1900.832,"body":"subscribe to our podcast."},{"speaker":"Jeff Cranmer","startTime":1900.865,"endTime":1906.404,"body":"Um, our sister podcast is on deck"},{"speaker":"Jeff Cranmer","startTime":1900.865,"endTime":1906.404,"body":"next, uh, the BioCentury Show."},{"speaker":"Jeff Cranmer","startTime":1906.804,"endTime":1911.976,"body":"this week we'll have, Steve, our"},{"speaker":"Jeff Cranmer","startTime":1906.804,"endTime":1911.976,"body":"Washington editor, in conversation"},{"speaker":"Jeff Cranmer","startTime":1912.243,"endTime":1915.947,"body":"with Jeremy Levin, so should"},{"speaker":"Jeff Cranmer","startTime":1912.243,"endTime":1915.947,"body":"be a very fun conversation."},{"speaker":"Jeff Cranmer","startTime":1915.947,"endTime":1921.552,"body":"Jeremy, of course, former BMS,"},{"speaker":"Jeff Cranmer","startTime":1915.947,"endTime":1921.552,"body":"former, Teva, uh, he's now executive"},{"speaker":"Jeff Cranmer","startTime":1921.552,"endTime":1923.888,"body":"chairman of Ovid Therapeutics."},{"speaker":"Jeff Cranmer","startTime":1923.888,"endTime":1931.696,"body":"Uh, that will be out, later this week,"},{"speaker":"Jeff Cranmer","startTime":1923.888,"endTime":1931.696,"body":"and we'll be back next week with another"},{"speaker":"Jeff Cranmer","startTime":1931.863,"endTime":1934.766,"body":"installment of BioCentury This Week."},{"speaker":"Jeff Cranmer","startTime":1935.099,"endTime":1939.671,"body":"thanks all for tuning in, and thanks"},{"speaker":"Jeff Cranmer","startTime":1935.099,"endTime":1939.671,"body":"to Kendall Square Orchestra for"},{"speaker":"Jeff Cranmer","startTime":1939.671,"endTime":1942.54,"body":"providing the music for our podcast"}]}