Recent reporting on Adverse Events: A Thoughtful Conversation on Safety, Transparency, & Next Steps

Jonathan James sits down with Dr. Akshat Jain to address the community’s questions following news of a serious adverse event in an extended trial of a new therapy, Marstacimab. They discuss Pfizer’s transparency, the careful investigative process ahead, and how patients can approach this information through open dialogue with their physicians. Dr. Jain provides an important clinical perspective and emphasizes shared decision-making when exploring treatment options.

Hope Charities is a national nonprofit focused on helping people living with rare and chronic illnesses thrive. Our programs specialize in helping people with genetic bleeding disorders and #hemophilia navigate the challenges of invisible disease by providing emotional, educational, and tangible support. To learn more about our programs, visit our website www.hope-charities.org.

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Transcript

The Adverse Event And Community Response

Introducing Dr. Jane’s Credentials

SPEAKER_02 0:05

Hi there, welcome to the Hope Podcast. My name is Jonathan James, and I'll be your host today. And I'm to come to you to talk about some really important information that I feel like is needed for our community. And I've invited a special guest with me today, Dr. Akshot Jane, who's going to be sharing some insights on some current events that I think are really, really important. And I want to give a little bit of context and introduction to our conversation today. Dr. Jane is going to be helping me to talk a little bit about a recent adverse event that occurred during an extended period trial. We were notified earlier this year about a specific occurrence with a trial that you may know this medication as Hemphavsi. There was a patient in China on the extended study program. They experienced some difficulties. They were actually taken off the medication, to my understanding. And there was a period of time where there was a surgery involved due to some comorbidity issues. And during that time, because this person was on the extended trial period, they experienced an adverse event and unfortunately passed away. This is really devastating news. We made certain that we publish this news on our website where you can learn more about these announcements. And I think that there's some important things as a community that we need to discuss when these terrible things happen, when someone has a reaction to a medication, when there's a situation that is really difficult for the people involved. Our hearts and minds and prayers go out to the families involved in this situation in China. It's really just devastating news. It doesn't matter if you knew or didn't know of the risks. Those things are very hard for all of us to embrace. But as a community, I wanted to take some time to talk about adverse events, trial design, and how these things really are processed from an investigative point of view. What happens? What does a community do when they start to get news like this? How do we investigate these challenges? I want to talk about transparency and how the community understands this type of information, what information we do have currently, and also what we'll be learning in the future. I want to talk a little bit about the trial design itself and how a company like Pfizer handles these types of events happening and what their response is. And also I want to talk about the important safety and efficacy changes of what may happen if this is something that you might be concerned about and what kind of conversations you need to have with your physicians. And I want to talk about how we can still understand the process and build confidence as we engage with information like this. I do want to just start this conversation out with saying that I have a tremendous amount of respect for Pfizer. They approached us, they came to many of the leadership in the bleeding source community and brought this information to light very quickly. There's a lot more to unpack here that a lot of things that they don't know, that they're going through the investigation process. And so you may or may not know Dr. Jane. He is an incredible hematologist that is the Humophilia Treatment Center director in Southern California. And he is in the trenches as the medical school director, and he holds a master's degree of public health degree from Sphora University and School in Public Health in New York City. Dr. Jane is a world expert in pediatric bleeding disorders and sickle cell disease, and is featured frequently on national and international media. His experience includes clinical pediatrics, cancer, and blood disorder diagnoses and management, global hematology, oncology consulting, and health policy formulation. His research and expertise includes developmental therapies, immunonomics, and outcomes-based research in clinical medicine, where he is well published and regarded as a key opinion leader. Dr. Jane is involved deeply in global health and brings hematology experts throughout his nonprofit organization, seeking patients and program development internationally. He's also an expansive experience in research. Dr. Jane has also helped with clinical trials design, implementation, phases one through four studies, and has served as a global and national principal investigator on many groundbreaking clinical trials since 2011. He currently serves as reviewer of several well-known journals as well as past editor of API Journal and editorial board member for the International Journal of Hematology Research. And so I couldn't think of anyone better to bring to the conversation today to talk about expert opinion on how these trials work and what the design is. Dr. Jane, it is great to see you. I know that that was a very long introduction, but the truth of it is your experience is so deep and so vast that I just appreciate your willingness to jump on here with me to talk a little bit about this current muse, but also the framework of all of these things that are happening. So welcome to the Hope Podcast and thanks for joining me today.

SPEAKER_00 4:55

Thank you, John. Thank you for the main introduction. The list is long, but there is a lot more that an effort of the team here than as opposed to just a personal accomplishment. Working with humor over the last 20 years, starting in Asia, Africa, and now in the United States, you know, there is you've seen this remarkable evolution of care delivery and therapeutic options that have come to us now. And as clinicians, as you mentioned down in the trenches, it is a responsibility to be more insightful and keep oneself updated with all these new therapies that are coming to the market and also keep a pulse on where the scientific discovery is going. We've come from an age where all we had uh was plasma-detrived factors. You know, we have a historical burden in the hemophilia community of some missteps that worked along the way you know many years ago. And that has kept us on our toes and kept even more shit for insight to make sure that everything that comes to market, everything that touches us, uh is right with us there. Extremely important is the community ASI, and I'm really thankful take effort and the airwave get this discussion going. So, really thank you for bringing this important development in our field to light. I'll try to share some of the insights that I can provide that might be valuable to your listeners.

SPEAKER_02 6:36

I really appreciate that, and also just appreciate your support as a community. You and I have had a chance to sit and have a longer discussion about women with bleeding disorders and many other really important topics. And I just felt like in this particular time, hearing of an adverse event like this really affects us all. It affects everyone in the community. And there's a different response that each of us should have when really thinking about these types of reporting issues. And I felt like it was important that we didn't just send out an email to the community or post it on our website, but we actually have a conversation about this and your support to help our audience understand what the different phases of an investigation are. And so I wanted to talk first of all about this particular situation specifically related to transparency and the communication with the public. Public statements like Pfizer's letter express heartfelt sympathies, just as we have. And while they're committed to transparency and ongoing updates, based on your firsthand involvement in trials, how do you think patients in the community should interpret these types of communications? And what insights can you offer to help people appreciate the careful balance between timely information sharing and respecting the investigative process?

Reading Company Communications Wisely

Rebalancing Therapies And Risk

SPEAKER_00 7:52

I think, Jonathan, as you rightfully pointed out, it is a responsibility to understand what is going on. We are going through a development phase where how we treat hemophilia, bleeding disorders for that matter, as a broader disease group, is changing significantly. There are options coming to the market that have never entried in humans before. We are at the cusp of innovation with multiple new ways of treating hemophilia beyond the common prevalent. If your factor levels are low, let's infuse factor into the veins to bring that level or hope that escalation of somebody's factor activity as a result of an IV infusion will mitigate the bleeding risk. But we find ourselves now in the rebalancing therapies age. These therapies not only go out and balance the coagulation in favor of patients with bleeding disorders, but additionally also with improved life, longevity, quality in terms of life, new development, new research that also brings out these clinical research. You know, as I was pointed out and has been in press release about the patient, a serious adverse event, as we like to call it in the clinical trial community. There is a lot more that we still need to learn. You know, just understanding of what went wrong that led to an unintended consequence is a process of a careful process of determination of really in the whole process, what was that triggering point? And more importantly, that triggering point does that translate into the outcome of an entire hemophilia community? Does that translate into parallels that can be drawn in the real world when treating patients? And most importantly, what that impacts in terms of future drug discovery, right? So one of the important things to understand is that a knee-jerk reaction to try to understand in the absence of all pieces of information may be disadvantageous for the advancement of novel line of lipezing hemophilia. So the way I have addression population, uh, the molecule in conversation here, Marstasimap rebalances tissue pathway inhibitor. I certainly have been told and I believe that we have one of the largest number of patients on Marstasimap since its commercial approval over a year ago in the United States. Having patients don't a therapy like this is not only of additional value that this therapy like divides, but also to keep those patients safe. And where we come in that situation of addressing the new problem that comes is to the patients to tread the waters carefully, yet at the same time to not jump to conclusions. So go to action here, it is there is an adverse event that has come out, there is missing pieces of information which will eventually complete the picture and help us under. And at that point, we will then reinvigorate our strategies of how we treat these issues. The patients that have taken advantage of novel therapies have really done very well. An additional point is the delineation between clinical trials and clinical studies when a patient is on during that process of investigation versus real-world utilization of medicine. Now, there are a lot of comparisons and contrasts with this sentinel case that we have heard about that may not translate into clinical practice or what we see. For example, what we have learned so far and have been told is this unfortunate event happened in a person that had a history of hemophilia with inhibitors. That is, in contrast to what we have in the real world, which is an FDA approval of this medication only at this time for patients without inhibitors. Translation of news like this should not raise alarm bells. That has been the messaging to our patient. It certainly calls for increased awareness of adverse events that can happen in the real world, all of which have had multiple discussions with our patients and so should be with all shared disengagement making process. But the additional importance is to re-ignite that insight to the patients who are on the therapy and hold their hand along this way as we are trying to make sense of the importance of not having a knee-joke reaction and discontinuing a therapy until and unless all pieces are very evident.

Trial vs Real‑World Use Clarified

SPEAKER_02 13:14

Yeah. You know, one of the things that you point out there is that not only is the FDA approved current status not for people with inhibitors, and this particular patient did have an inhibitor. There was evidence that we know so far that there was lots of comorbidities that that also were going on. It wasn't just this wasn't a nice lady of the event. There were some other health concerns going on. And that's not dismissive. I think questions that come to my mind in this conversation also is is it possible that this is a systemic problem, or is this something that is just isolated to one person? It's tragic no matter if it's just one person is tragic. But in the sense, there's some questions that I believe that the investigators are really trying to understand. I think of this situation similar to a story of like if you ever are driving along the highway and you come up along next to an ambulance who is at the scene of a car accident. We kind of need to let the experts at that ambulance take care of the people in the accident, really do a thorough investigation to understand all of the intricacies of what's happening. Once we have as much information from the investigation, then those are things that can help us make educated decisions for ourselves as a patient, for clinicians as a practitioner. And I think that's something very important for us to keep in mind. Is there anything you think of when responding to this that would lead you to advise your patients in one way or another when you learn of something like this happening?

Counseling Patients Without Panic

SPEAKER_00 14:55

Absolutely. Yeah, I think this is the most important question for the hour. I think how do we uphold the responsibility of practicing medicine as a clinician by balancing the responsibilities of conducting clinical research? Now, I happen to be in a unique position, the delineation has to be made very clear. To answer your question, I think the first point I'd like to make is a resurance to the community of chronical trial standpoint has to be made. Events like these, in therapies like these, that have hit the clinical lab and clinical development process for the first time. For example, the TFPI molecule that Marseille map targets had never been a treatable target that had been used for any disease. Knowing that we are at the cusp of an innovative therapy coming to market, some of these unwanted surprises are the cost we have to pay for innovation. The guardrails we put in place while designing a clinical trial are very, very, very deeply rooted into the core principles of justice, of beneficence, and respect. When we design a clinical trial or we maintain a patient on clinical trial, the oversight of serious adverse events is extremely high. The cognizance of even minor adverse events usually puts the clinical trials on hold with something that is considered very trivial in the clinical trial world is taken very seriously. So there should be a message, a reassuring message that all clinical trials we conduct certainly with myself and my stakeholders that I initiating a clinical trial. The principles of conscience and equipoise absolutely absolutely tested on time and time again with our outbasses to make sure now moving on to the other song, which is how do you address news with your own patients when a new news breaks out about a new drug situation because this news has come out from a patient who had been on the medication for years before a serious adverse event occurred. Were there contributory factors that led to that adverse event? Were there other aspects of that person's health that led to it? In due time, we will have that information and messaging will become more accurate, more logical, and I think will provide closure to the patients and clinical trial participants. But when it comes to the real world of using a medication which is now approved in multiple continents and is being utilized by clinicians like me all around the world, the differentiation of making people understand that each case, each clinical trial participant is unique with their unique set of complexities, is where I usually start out with reassuring the families that while an event may have occurred, that does not automatically translate by enhancing the risk of that life-threatening event occurring in every single patient or that particular patient or that particular family. Number one. Number two, being transparent as Pfizer has been with us, with whatever information they have gathered, they have been forthcoming in providing and sharing it in a very timely fashion. And I think that speaks to the community and collaborative partnership that industry and academia has encouraged over the years. Making patients understand that this is not without risk. Understanding and identifying the risk factors to keep an eye out if they start happening and can be timely managed is the most critical piece of re-educating patients. When this announcement came out, I've had a conversation and a clinical visit with every single patient in our program. About two dozen patients that are on it. And that conversation was too a two-parter. One, making exactly what I knew so that everybody is on the same page. And then two, giving them the option of shared decision making. In light of this information, no app we're comparing apples to oranges, and the parallels cannot be drawn with a straight line here. I've given every single patient, every single family that is on Merstasemab in under my care an option in the space of shared decision making to whether go back to an alternate regimen or go back to the medication and regimen that they were on before being switched to Merstasemab. A creeping anxiety and being in that space and the fear of the unknown weighs on our hemophilia patient community a lot. Until and unless we have all clear answers, that is due diligence and certainly shows responsibility to the patient population and lets them feel that they are in. And that is a strategy we have realized in the real space. I'm happy to announce some of our patients that we have had this conversation with have decided to seek therapy and decided to be on the watch for any adverse event or early onset sign and symptoms of such early events that may or may not have occurred. Prospectively looking forward to make sure that if God forbid such an adverse event happens, it can be nipped in the bud and timely care can be provided to these patients. I thought that was the most logical strategy, given the light of this information, which was previously not a common occurrence during the last five, six, seven years of clinical development of MarcusMap.

Respect, Consent, And Trial Phases

SPEAKER_02 21:16

That's wonderful to know that you took this information and immediately went to your patients who were on the program and on this medication. You immediately had shared decision-making opportunity with them. I think that is so important for all of us to remember if someone's listening to this right now and maybe they have contemplated being on this therapy, or maybe they are on the therapy like this. This is a perfect opportunity for you to have a conversation with your provider to ask for that expert advice and to have shared decision making occur. I love the fact that you took the initiative to immediately reach out to everyone on your roster because that shows just how much uh you care and how much. You know, uh option that you wanted to provide to them directly. And I just I cherish that so much. I would encourage people who are listening to this, if you've been on this treatment or if there's a treatment that you have been even thinking about being on, that this is a concern for you. This is definitely something you need to speak with your provider about because this is the opportunity to make you want that input. They're going to have the best information, the most accurate, up-to-date information, having that and not just sitting with it and worrying and being fearful. There are people out there that they hear things like this and it causes people to freeze up and not want to do anything and not even take the medication they've been taking for 30 years. I don't think that we need to let fear grip us. I think we need to engage in conversation with experts and take this to that level of conversation for shared decision making, right?

SPEAKER_00 22:53

Absolutely. The principles of designing a clinical and the principle in clinical medicine, you know, are not all that different. One of the principles of designing or conducting a clinical trial is respect. This is a core tenet in any clinical research body, whether it's institutional, national, or global. The word respect in clinical research means autonomy and informed consent. Patients that do sign up to be on a clinical trial are taking a leap of faith, they're taking a chance. There is the risk-benefit analysis that is always discussed, and there is always the something going wrong wrong because clinical research is experimentative in. And unless an experiment is done with some of those calculated risks factored in, we would not be where we are with all these amazing therapies that have really pushed the lives. As a clinical researcher, I take that edge off with a grain of salt of benefit analysis when I initiate a trial at my site, or if I'm designing a clinical project that would be at multiple sites. If you think about patient care, it's not very different. The first patient that decides to switch to a conventional factor therapy, to a non-factor therapy, they are taking those similar risks, they are taking that leap of faith with you. My role and responsibility and my care team is providing the best and latest information that's out there for that particular drug mechanism. Because there are things we still don't know about the human body, about hemophilia. This is the best possible knowledge we know so far for the patient, the family, the caregiver, the parent, the wife, the husband, the grandmother, to make that right risk-befit analysis in that household on that dinner table is really the responsibility lies for us as clinicians. And when missteps or serious adverse events do arise, sometimes much later in the clinical trial process, it is the responsibility of the clinical team to make sure, I think, to make sure patients are made aware that this has happened, as opposed to patients finding out through a news blast or on their Facebook. This is an opportunity to build trust and continue to build up on that trust. Staying calm and making communication very clear is the best strategy in safeguarding patients' interests because patients come first, everything else is secondary, at least the way I think about it.

SPEAKER_02 25:59

That's so good. One of the things that I don't think is always easily understood is that these types of medications have been in trial phases for quite a long time. I mean, you've got phase one, phase two, phase three. My understanding is this particular portion of the trial was an extended period, which is really stage four, if I'm not mistaken. There's an element where many years go by where it's tested in the test tube to see if it's going to work. And then it's tested in the lab with a small animal sample and then a large animal sample. These go on for years before they ever get into a trial program where there's a human involved. Once the human is involved, there's still other variables to explore. And then there's continuing research, which is really even after it's been on the market, somewhat, that's the really the phase four trial. In those phases, this is not taken lightly. And as you said, respect is core to the way that these trials are conducted. Informed consent, where the person is fully informed. We've seen a lot of gene therapy trials, for instance, which this is not a gene therapy, but we've seen some of those trials that people knew going right into it. I've spoken with many people who were in the trials, that they knew for sure there was some risk involved and they were aware they were signing up for something that was still a lot to be learned. And in this particular case, this was going on for five, six, or seven years before there was an adverse event that happened. And even with that, I think transparency really helps to shape the accountability and the communication that we have and shouldn't be something that we should rush to fear or worry, but it's something that we should be informed about, we should learn about, we should be aware about. And that informed consent is a piece to the respect that is needed so that you can make the best decision possible for you and your family. And that's one of the things I love so much about you and the way to practice medicine, the way you help your patients. You're always trying to put the most information in front of the person so that they have the autonomy to make the best decisions possible. And I appreciate that about your approach to medicine and also just how much experience you have with making sure that people are well informed before they ever even get into this process on the front end.

Oversight, Setbacks, And Guardrails

SPEAKER_00 28:13

Yeah, you're right. I mean, you know, the the phase where this study was was open label extension study. The prank safety analysis efficacy had been completed. MarstasMap was one of the rebalancing agents, the only one that wasn't put on hold due to an adverse event during clinical development by the FDA. So really had a very clean profile before Marstasimap got to FDA for final approval and then to market, as opposed to some of the other ones. Having said that, we have seen time and time again, whether it's development of cancer therapeutics, immunotherapies, gene therapies, whether for hemophilia or other muscle dystrophies and other disorders, there are always setbacks. This is in no way not an unfortunate occurrence. This is in no way something that can be um shoved under the rug. This is something that has to be seriously considered. It has serious implications of how we utilize this way of treating hemophilia. This will change the paradigm of rebalancing age. So this is not at all diluting the importance of this occurrence, but this is what happens when clinical development oversight on clinical trials is done appropriately. We catch something, report it in time, and transparent information. That speaks to the respect part of clinical development and the justice which every clinical deserves, whether they are in an acute of clinical study, openable extension, or a post-marketing analysis or phase four study. There have been drugs on the market. We've seen it in the cardiovascular space that were in that space for many years before the serious adverse event was linked and the drug was then pulled off to the market. But as I said earlier, the price of innovation comes with a clear conscience of the clinicians, the clinical developers, and every other stakeholder, including people in the advocacy space like you, to make sure that this gets communicated in real time. It does not create chaos or panic. And yet at the same time, we keep our guard up. We encourage the patients and caregivers to keep their guard up because this just changed the game. How we move forward, how we come out of this occurrence. There were hundreds of patients during clinical trial period that went on this medication without having a life-threatening adverse outcome, which is why FDA ascertained that this medication is fit to be approved. And one-offs, albeit significant, cannot be generalized, I think. And this goes with all novel therapies, whether it's the anti-thromin-based therapy, other DIPI-based therapy, or gene therapy. Every patient is unique, every occurrence is a unique, and they should increase our caution and oversight. It's the lesson for all stakeholders and also for families. But I think the messaging is pretty on point, and I think we are doing the right thing. And at the same time, I would also, in the spirit of be critical, I think we all are also, by doing activities like these, upholding our holders to account. And uh we should continue chugging along that path to make sure that the advancement of therapeutics that is happening in our field doesn't get derailed because of such unforeseen one-off events.

What To Expect From EAHAD Updates

SPEAKER_02 32:02

Yeah, agreed. One of the things that we understand is that they are going through the investigation process right now to try to understand all of what they can about the patient, about the circumstances. And then there's going to be an announcement, I believe, in their last statement on this. They're going to be giving late breaking sessions at EAHAD Congress in February, which is good. Tell me a little bit about uh how you think this process is going. And once we get there, that's where a lot of the physicians, if I'm not mistaken, that's where a lot of the folks like you and other treaters that are dealing with this, that's where we're really going to get uh to know even more information about what they learned about this particular situation. And I think that's where we'll have more information.

Practical Steps For Patients Now

SPEAKER_00 32:50

I think what Pfizer is doing right is as the information is coming in, they're community in public media space, they're community with community advocacy associations, like Hope Charities, What Federation, Hemophilia, NBDF, all the partners, all the stakeholders. And uh as an investigator, I'm also being apprised in real time of when that information starts surfacing. We recently went through a webinar that the company had organized to keep people around the world informed as new information surfaced. I think this presentation in Dublin next month at the European Hematology Association will be certainly very valuable to help us understand and delineate really whether this was a one-off event or a commonality or something that should lead to a paradigm change of how the FAA safety analysis has been performed, how we take from that information in guiding patients with clinical implications, and how we design future clinical trials for the same drug. For example, there are ongoing studies with the same molecule for pediatric population, safety analysis. There is an ongoing study for patients who plan on deciding to switch from one subcutaneous modality to another subcutaneous modality, such as Burstase Symptom here. That study is underway right now. So knowing and understanding the clinical integrity of the deep science with relevant information that's available from this one case will help us raise the guardrails and our oversight with how we are conducting the next generation clinical trials for this molecule. Because this molecule has really changed the lives of our patients, and so have the other novel therapies in the space, whether it's consosum up, fiduceramic, etc. There is a right patient for every therapy, and patients are taking advantage of it. We need to hold ourselves to higher accountability in the clinical development that will address some of the inequities and the gap of extension of these therapies to some of the minor populations that have otherwise been on the sidelines, population, women with hemophilia, and still to be studied both for safety analysis and efficacy analysis. So these informations at scientific levels will help us clinicians be better informed so we can get the messaging out through the extended community with better clarity. So I think it's very timely, and I'm very happy that they are doing this.

SPEAKER_02 35:41

That's wonderful. As we close out today's conversation, I do want to think about what advice you might give to someone who is a patient that's listening to this, thinking, gosh, hear all this information and I don't know what to do with the information I've learned. Is there any questions that you would recommend that maybe a listener should be contemplating for themselves? What questions should we be asking ourselves as we digest all of what's happening here?

SPEAKER_00 36:12

I would say schedule that appointment with your hemophilia physician. Have an open discussion in light of this new information, and try to see if there's any commonality because a lab maybe course correction is indicated. Give a word of reassurance, at least from my limited experience in our patient population. We've been very fortunate by God's grace that you know our first patient that started MercedesMap has crossed one year of therapy with tremendous success, an improvement in overall outcome of hemophilia and its subsidiaries, pain, joint health, etc. Uh, drawing from real-world experience of what's happening in the field and connecting with peers through the local hemophilia communities and hearing physicians who are willing to share the real-world utilization, the real-world case scenarios is absolutely critical. But for the for the person who goes on Google on social media and tries to figure it out from themselves, I would certainly say instead of trying to figure it out by yourself, there is always the hemophilia provider, hemophilia treatment center you can reach out to and certainly get the right information before making up your mind to therapy one way or the another. Or if you're on your therapy, to be ready with what you can actually change, is being aware and prepared for an adverse event if it ever happens, so you can catch it in time and also make your care team aware. Whether that care team involves your primary care doctor, obstetrician, ancologist, a specialist physician, and all of your family members, they form the safety net for that patient, right? So as opposed to figuring it out yourself, have a collaborative decision. There is enough information out there that a important decision can be made. And if there is a course correction that needs to be made to make you more happy and less anxious, I would say go ahead and do that as well. The last thing you want to do is worry without having an action plan moving forward. And that's something that I would not recommend for anybody.

Resources, Events, And Closing Thanks

SPEAKER_02 38:25

It's so good to think about that collaborative nature of how we can work together to have shared decision making and how important it is for us to link arms with one another. We're publishing these announcements as they are provided to us on our website. So people can learn more about it at hopecharities.org. We're getting ready to do an online educational seminar that people can come to to learn about different emerging therapies that are coming out. We are in a renaissance period in the hemophilia space where many investigations are going on and there are a lot of new things coming at us. We'll be talking about opportunities for people there. So there's plenty of opportunities for people to connect, but I agree fully with what you said that you got to lean into your resources, have that conversation. Don't just come with a preconceived idea. Get as much information as you can, trust the process. There is a certain process at hand. Let's get as much information as we can. But uh, with all of that said, Dr. Jane, I just want to say thank you so much for being available and willing to have this conversation today. As we have more information coming out, we'd be sure to reach out to you for advice. Thank you so much for what you're doing for your patients, your community, of your treatment center. Thank you for what you mean to me and our community here at Hope Charities. We love you and we appreciate you seriously for giving us the guidance of peace of mind to know exactly how to interpret all of this information coming out.

SPEAKER_00 39:49

No, Jonathan, anytime what you're doing is very timely and it contributes to getting the messaging out, making people more aware, and maybe alleying the panic and the anxiety that such an random brings with itself. Uh so thick you for your service to the extended leading disorder community. It's critical, timely, and very poignant. So thank you again.

SPEAKER_01 40:14

Well, thank you, and uh, we look forward to seeing you very soon. Thanks for now.

SPEAKER_02 40:20

I just want to say a big thank you to Dr. Jane. He is an absolute, uh, just uh a wonderful friend, and he's been an incredible research source for us to help ask these difficult questions. So you might be watching this or listening to this on the podcast channel, thinking about questions that you have. We'd love to know what those are down in the comments. And also you can email us anytime at info at hope-encharities.org, and we would be happy to do our best to answer any questions that you have. As I mentioned during our discussion, we are getting ready for our emerging therapies conference, and we would love for you to join us for that. That's gonna be February 24th and 25th, and it's online, so you can join from anywhere. It's really gonna be a great time for us to be able to learn more about what other types of therapies are coming out, what is going on. Moments like this are so important for us to gather together as a community, to link arms together, just like Dr. Jane said, to learn as much as we can and uh from each other and also from experts who are in the field doing this work every day. I know just as a person living with a bleeding disorder myself that when I hear news like this, I'm both devastated, heartbroken. I have to take a step back and remind myself that there's a lot more to this process than what meets the eye. It's important to approach these things with an open mind and make decisions for yourself. Without all the information, it's hard to do that. It's important for folks to have conversations with experts like Dr. Jane and many others who really can help us give us that that feedback that we need to understand the process, to understand what the limitations and the possibilities are so that we can make the most informed decisions that we can. So I want to say a big thank you again to Dr. Jane for taking time out of his important schedule to be with us today on this podcast. And thank you to all of you who've taken the opportunity to listen. It means so much to us. If you haven't already, we would appreciate it. If you're watching this on YouTube or one of those other channels, please feel free to like and subscribe. It does help us to be able to get the content out to more people. We hope to get more updates about this important issue and many others in the future. Look forward to seeing you very soon. Thanks for your time today. We'll talk to you soon. Thanks. Bye.