Avacopan (Tavneos®) in GPA and MPA 2026

本站收录: 2026-05-22

[00:00:00]Okay, good morning, good afternoon, good evening everyone and thank you for joining us today. I'm Joyce Coleman, the executive director of the Vascalitis Foundation.

[00:00:11]On behalf of our entire team, welcome to this educational webinar focused on Tavnio, also known as Avakapan, and the recent developments involving the FDA, TABOS, and Amgen. We know many of our patients, family members, care partners, health care professionals, and others in our vasculitis community have questions right now. Our goal today is to provide clear, balanced, medically in informed information in a respectful and supportive environment. I have just a few housekeeping notes. We are recording this webinar and the recording will be made available after postp production.

[00:00:50]Audience recording of this webinar is not permitted and the chat window is turned off today. Our experts will address the presubmitted questions that the VF has been collecting over the past few weeks. Please complete our posteinar survey so that we can continue to improve our educational webinars. And finally, by next week, all of you will receive an email with the YouTube recording link, additional educational resources, information on submitting public comments to the FDA, and a gentle reminder to complete our posteinar survey. This webinar is in intended to provide general educational information and should not be considered individual medical advice. Every patient's situation is unique and we encourage attendees to speak directly to their health their treating health care team before making any changes to their treatment plan. We also recognize that there may be participants joining us from many different perspectives today, including patients, care partners, health care professionals, researchers, industry representatives, and members of our community and the public. Our role today is to focus on education and patient support. The F the VF remains committed to providing independent evidence-based education for our community. The VF's awareness and educational programs are supported in part through grants and sponsorships from industry partners including Amjen.

[00:02:25]All content is developed independently by the Vascalitis Foundation which remains which maintains full control over program planning, educational content, speaker selection, and resource development.

[00:02:40]We also want to take this opportunity to encourage patients and community members to submit comments to the FDA regarding their experiences with GPA and MPA and TABNOS. Our presenters will discuss how this can be done during this presentation. This information will also be sent in our postevent webinar email.

[00:03:02]Now, I'd like to welcome our two expert physicians joining us today. Dr. Kevin Byum is associate professor of rheatology and immunology at the Vanderbilt University Medical Center and is past president of the VF board of directors. He serves as our co-chair of our medical and education research committee and is the co-director of the Vanderbilt Vasculitis Center.

[00:03:29]Dr. Alex Villaforte is a rheatologist and staff physician at the Cleveland Clinic Center for Vasculitis Care and Research. Dr. Villaforte serves on the VF board of directors and is chair of our project echo and vasculitis 101 medical hub task force. I want to thank both of you for being here and for sharing your expertise with our community. We will begin with a brief overview from our physician speakers about Tabnio and the current FDA developments followed by a discussion of questions already submitted in advance by our community members. With that, I'd like to turn things over to Dr. Byum to begin with an overview. Thank you, Dr. Byum.

[00:04:12]>> Thanks, Joyce. uh we appreciate that introduction and this opportunity to be with the community and try to provide uh some insight into uh recent happenings.

[00:04:22]So, as Joyce uh said, we're going to be talking over a timeline of Avakapan and a history of that um in context of the recent current FDA actions regarding aapan. Um, we also are going to be going through some presubmitted questions and then uh I think importantly how patients can share their comments uh and experiences that they've had uh with this disease and this medication. Um you'll see a couple of slides on that.

[00:04:54]Um but moving forward so this it's right here. So if you uh I will re we will reshow this at the uh later on in the webinar but if you are interested in sharing your experience uh with the medication um uh or the disease uh you can uh uh provide a public comment. I think that's the important thing to understand is that these are public comments and uh so anything you wouldn't want to share publicly you shouldn't share. But you can see here that you can consider uh side effects, safety concerns, impact on your quality of life, effects of long-term steroid use uh and your experience with tabios or avakipen in terms of effectiveness. Um and there is a a QR code there as well as a website um that you that you can reference.

[00:05:42]So I'm going to start with just what is avacapan or tabios. Uh the generic name of uh is avacapan. The brand name is tabios. This is a medicine that is used together with gluccocorticoids um that's the other word for steroids of course and other standard of care medications to treat adults with severe anka associated vasculitis. These are diseases including granulomitosis with polyangiitis as well as microscopic polyangitis. Um it doesn't totally eliminate gluccocorticoid use but it can allow less glucorticoid use uh in the treatment of these diseases. And this is a first-in-class uh medication. The mechanism is what's called a a C5A receptor inhibitor.

[00:06:29]So a a history of the timeline that's of what's going on recently. Uh there was a a large phase three trial um uh done by the company Chemocentrics which was the developer of Avakapan. Uh this is a trial called Advocate. This uh was done between 2017 and 2019.

[00:06:51]This was after a phase 2 trial that was done in the years prior to that. And in October, this culminated in October 2021, the FDA uh after deliberation approved a vakipan for adults for the treatment of severe active anka associated vasculitis.

[00:07:09]About one year later, Amgen large pharmaceutical company acquires they they buy chemocentrics and the medication uh of aapan um and many patients were treated in that time period.

[00:07:25]We fast forward several years to January of 2026 and it was at that time the FDA requested that Amjen um as the owner of the current drug voluntarily withdraw a vakipan from the US market citing concerns about the process uh followed by chementrics readjudicating endpoints in the trial of nine of the 331 cases in that advocate trial. Additionally, they bring up the issues of hpatotoxicity or liver toxicity that were described in the prescribing information. Um, and they so they raised questions about the context of the the balance of benefit and risk of this medication.

[00:08:09]A few weeks later, Amjen replied following a regular regulatory process informing the FDA that it did not intend to withdraw the a backup uh withdraw the medicine from the market, but they would continue a conversation with the FDA uh in that regard to um because of course they believe in patient safety as well.

[00:08:29]Um, a few uh weeks later in March, at the end of March of 2026, the FDA released uh a document called a drug safety communication or a DSC.

[00:08:42]And this was a a document in which the FDA alerted patients and providers, healthcare providers about some uh drug injury uh liver injury cases associated with the drug. Some of them fatal including um uh what's called vanishing bile duct syndrome. A few cases of that which can be rare. It is rare and it can be severe. Um you might hear us reference dilly d i l i. This is drug induced liver injury. But in the in the drug safety communication that was released, 76 cases were uh reported including seven vanishing bile duct syndrome cases. This is not a new signal uh as of March 2026. We had known this uh for some time and it is actually included on the label to to watch out for um hpattoxicity in the form of drug monitoring and we're going to talk a little bit more about that in a bit. Um, in April of 2026, at the end of April, about a a month later, the FDA's, uh, Center for Drug Evaluation and Research, uh, wrote a letter in which they propose withdrawal of the approval of a vakipan on the two points that we've brought up so far. One is um quote lack of substantial evidence that the drug will have its effect uh and is represented to have under the conditions of its use prescribed, recommended or suggested in the labeling and untrue statements of material fact in the application. They additionally in the letter bring up the idea of drug toxicity, but the letter is mainly aimed at how some of the trial uh was performed.

[00:10:34]Um there is currently a public comment period that is open.

[00:10:42]We've mentioned that and in as part of the regulatory process Amgen they may request a public hearing to uh further address these concerns. That's up to the company and in their conversation with the FDA. Um let's see here. So there is it's a rapidly evolving space as this population probably knows. It seems like every you can see by the timeline every month or every few weeks there's new information. So depending on when you're watching this it might be that the situation has already changed. But we have a note here that Amjen of course posts uh periodic updates and um and there is an FAQ online which was last updated several several weeks ago. The VF in an effort to uh keep our um population and in our community informed has also released three statements which generally link to um kind of primary documents, primary information based on this topic. I think the last thing I'll say and for clarity in terms of the uh this April 27th 2026 letter u because is just to clarify kind of what it what happened when clinical trials are performed. Most big clinical trials are done in a blinded fashion or even a double blinded fashion where the patient doesn't know if they're on the medication or placebo. the provider that's doing their assessments doesn't know if they're on treatment or placebo.

[00:12:17]And this really helps uh mitigate bias that can occur in clinical studies. Um what happened here was that the the information the the data from the trial was unblinded. Several cases were readjudicated, not all cases. And so it leaves a space open for bias in the the scientific data. And that is the issue that is the foundation of this FDA letter in April 2026.

[00:12:52]So I think with that I will again show you how you can um uh share again public comment with the FDA if you feel so inclined as part of this community um as a user of this medicine or otherwise.

[00:13:09]Um and I think at this time we'll add more clarity and granularity around some of these issues uh with some presubmitted questions to try to get some more information out. I just want to uh again bring to your attention that it will be tempting to want to interpret what we say today as medical advice that is applicable to your particular case if you're a patient or a family member of a patient with vasculitis. But that is not what we're doing here. Um you need all medical decisions on your individual case needs to be uh considered with your individual physician. I should say that there might even be patients of mine or patients of Dr. Villa Fores on and even in that case this does not constitute medical advice. Um you know you should get a clinic visit and we'll talk about it in that context in the specific context of your own case.

[00:14:04]Um let's see here. Dr. Villa Forte before we start questions is there anything you want to add at this point?

[00:14:13]>> Uh no thank you. Uh Dr. Bar I think you well said and detailed and we can go ahead and start the questions.

[00:14:20]>> Sure. So I'll ask you the first one and then you can retaliate. Okay. Um these are as these are dealing with you know some safety issues. So one of the most common questions we're getting at this point is should I should the patient stop a vakipen or tavio right now? How would you respond to that in general?

[00:14:40]>> Okay. So I don't recommend that anyone should stop uh their medication based on just what's happening in the FDA uh statement or the response from Amjen. Uh the aacopan or cabinets should be continued or stopped based on a recommendation from your physician. Uh because is a individual decision and share a decision with you obviously and discuss with your physician about the benefits and risks which may change from one person to another since each one has a different uh severity or manifestations of the disease or may be in a different stage of treatment. So this should not be taken as a one answer fits all. So discuss with your physician before you decide to either stop or continue the medication because you might take an action that might be more harmful than beneficial if not discussed pri a priority with your physician.

[00:15:39]>> Very good. I agree with that. I know you have a good answer for this next one. So I'm going to I'm going to ping that one at you too. is another question we get a lot is how often the liver labs should be checked. Um how would you respond to that in general?

[00:15:54]>> Well, this is an interesting question because I believe I mean that's what we have been doing. I believe that is true in the US that the way we've been checking the uh labs um have been in a very frequent and controlled way. So since the beginning when uh bean was first uh approved in 2022 and we all started using this medication, I have and and most of the physicians in the US I believe have checked uh the labs to monitor the medication two weeks after starting it and if the results are normal, we continue doing that once a month uh throughout the treatment and has I have continued doing that and this has been done since the beginning 2022 and I I think this way we capture any changes and at onset of any changes of liver enzymes. So if there is very early signs of possible uh liver uh injury we are able to act on it very early on avoiding further damage. So uh my recommendations to my patients have not changed because I've been doing that since the beginning and uh I would recommend to continue doing this way. So again, uh I do check the labs two weeks after starting day of acupan and then once a month after that.

[00:17:15]>> Uh very good. I agree that's in line with my practice too. All right. You can ask me any of these questions that you >> All right. Uh so um and and we do know it's kind of an unfair question in a way because uh each country has different uh frequency of u uh liver injury from aopan. If you look at the data so but in general how come liver injuries uh in the literature >> it's yeah it's a challenging question to answer for a couple of different reasons different um countries and practice settings might have different monitoring protocols and that one wonders how much that might contribute um to kind of finding a a liver injury late perhaps but uh I think my short answer is I don't know attributing a liver injury or any side effect to a medication is actually pretty challenging uh particularly in regular clinical practice as well because in many cases a patient is not getting only a vakipan or tabnio they're getting many other medications as well which all have their own risks of uh side effect including liver toxicity um to restate it was around 70 or 75 cases that were reported and of those seven of the vanishing bile duct syndrome cases But to think that though that that is all that is out there is probably not correct. Um and I I think it remains to be seen. But this is one reason why longer term clinical trials are done. Um Vakapan was in the context of uh was in process of another longer term trial uh to answer questions like these and some others in terms of long-term efficacy.

[00:19:02]So I think my short answer is that I don't know but I would classify it as rare.

[00:19:07]>> I agree and and like I said different frequencies in different countries maybe from different protocols and if we look at the advocac the advocate trial that was about 5.4% but Japan has reported anywhere from 16 to 40%. So it's a huge difference if you uh compared to the data in the US and I agree with you it might be from protocol differences. Uh the second question is uh related to other medications and I'm interpreting that as used at the same time with a backben. So benefits and risks of other medications that may impact your decision about using a backb or not or or beyond that.

[00:19:48]>> Yeah. Then this is the crux of the issue is uh this is the challenge that we find ourselves as providers to patients with vasculitis.

[00:19:59]This is what we're dealing with every day in the clinic is trying to balance the risks and benefits of certain approaches. So historically, of course, we've used high doses of gluccocorticoids and tapering those over time. We have learned that even outside of a vakipan, we can use less steroid. Um but um with or sorry without a vakipan, we're still looking at months and months of at least you know moderate doses of steroids and with that it has a lot of side effect. I think anybody that's been on glucarotic or that have prescribed them are familiar with this risk profile, but people can gain weight and uh get new diabetes or worsen their already diagnosed diabetes. It can mess with people's mood in terms of anxiety, depression, or worse. Um it can it's toxic to muscles, can cause infections.

[00:20:52]That's probably the biggest thing we worry about. Um and then longer term of course it can uh contribute to uh osteoporosis um and things like that you know glaucoma um other uh eye issues. So you know we we have a a good sense of what our current treatments and that's just steroids by the way of course there many uh patients are being treated with other medications like rottoximab or methtoresate or microfenolate or aithopine and so all of uh those medicines I just referenced also have their own risk profiles.

[00:21:30]Um what what is challenging is that of all these that I mentioned, Evacapan is kind of the newest kit on the block. And so uh we have a we think we have a good uh understanding of the risk profile of many of our other medicines. And as you use a new medicine, you gain new insights. And so I guess that's another comment to make is that it's really not uncommon for, you know, us to learn more and more about the safety profile of a of a medication like this drug induced liver injury issue with a vakipan. But it's all about coming up with ways to mitigate that like you mentioned aggressive lab monitoring um etc. >> I agreed. Yes, that's great.

[00:22:16]Um all right so we'll move on to these the efficacy and data integrity questions. So I guess the comment before I start asking the questions is that we we are talking about the FDA a lot right now but there is there are similar regulatory um agencies in other countries and continents. So there's the EMA I believe in Europe and then Japan for example has their own. And so we're using FDA as a little bit of a surrogate here. that similar issues have been raised uh for each of these other regulatory agencies mentioned. So with that said, um this is a tough question, Alex, but what does it mean? Can you give more context about what it means that the FDA questions the integrity of the data?

[00:23:02]>> Well, basically the FDA is doing its job. So the FDA is this control um institution that is making sure that medications are safe. uh they're used in the best way. Uh they may make recommendations about monitoring but they keep uh an eye and uh they survey and analyze some of the data and results of trials and which sometimes leads to approval by the FDA uh when they find that the drug is efficacious and also uh safe uh and would benefit more than do any harm. that the FDA continues to uh monitor the situation of medications after its approval. And here what the FDA is doing is questioning uh the safety of the medication basically, but also questioning uh how the data was handled like you mentioned before. So if the FDA um believes that there is enough evidence that the data was handled in a way that was not um believed to um result in reliable data or reliable results, they will question the results of the study. Well, if they're questioning the results of the study, they'll question their own approval of the drug. So it's a step-wise approach to uh make sure that the approval is valid and should continue and also that the safety is there. So it doesn't mean that automatically something is going to happen or result. is just an ongoing dialogue between the FDA and the pharmaceutical company to continue to analyze this data and then hopefully with this dialogue come to a conclusion uh if they both agree that uh the results of their investigation means that the medication is uh safe and it leads to more benefit than harm and it should continue to be approved. So I I think at this point we we should look at this more of a like a dialogue in a way but but there's a lot of questions that need to be answered and and that's what the FDA does and it does to a lot of different drugs. It's not just a well >> yeah I think that's really well stated really well stated.

[00:25:24]>> Um do you want to comment on this next question? Do we have real world evidence? What does the real world evidence show about a vakipan safety and efficacy? We have the latest.

[00:25:35]>> Yeah, we actually do. We we have quite a bit a good number of real world evidence that is published and available. So that can be looked at and then um it's it's published for physicians as well as some of it is free online. So I think that when you look at overall there are different countries that have looked at the real world evidence and as a general statement this data is in its majority very positive and [clears throat] continues to show that uh uh is effective. uh it's uh as it was shown in the first uh uh data from the advocate in certain aspects superior uh to uh the comparative group that did not take cavities uh and also very importantly reduce the exposure to steroids uh which is a plus in the treatment of this disease that requires such a long uh exposure to steroids in general. Uh so this this data is available and uh I think it will be helpful to continue as they continue this dialogue with the FDA. I I suspect that this data will be important because it does reflect also the safety issues because of the reported cases with with liver injury. So it will be a rich source and a good source for um understanding better what are questions from the FDA. Yeah.

[00:27:10]All right. You can pepper me with some of these.

[00:27:13]>> All right. So in in continue this idea of the real world data and decision and the questions always come what are the risks of stopping and continue in this situation. And I guess the question is saying the risks of stopping continue if you make this decision based only on the existing problem uh and current question in from the FDA not because your physician re recommended it because otherwise it would be obvious. Right.

[00:27:41]>> Right. Yeah. This is um I think every case will be different. I think you know some patients have had uh let me just name I think a lot of the factors that go into I think it almost goes to answer both of these top questions is the factors that physicians and providers will be thinking about having in their head trying to integrate all the whole picture as they make the decision about whether to stop or continue the medication but uh you know the the individual patient they're going to have their own coorbidities for example I I mean the thought experiment here is if the patient has underlying liver disease or predilction for liver disease well then that might be somebody that where the the risk outweighs the benefit and with an evidence that we have or knowledge that we have. Um let's say we have somebody the the the risk of their disease flaring. If a patient has a a lot of flare history um or a lot of steroid toxicity over time, well then it might be the opposite where the the benefits of continuing might outweigh risks. Um there are also other uh things to consider interactions with other medications.

[00:28:53]um the need of if you were to have a flare to have to go on high doses of steroid I think um what other treatments the patient is on already uh whether it it's uh one of the ones that we've mentioned or something else um and what sort of damage the patient has had from their vasculitis. So if the patient even if they haven't had um severe uh or or relapsing disease rather but they had very severe onset and had a lot of damage occur at the beginning this might be this might play into the decision about stopping versus continuing a vakipant. So I think what we worry about is our patients um make overthinking it in some sense and um making a decision without the input of their provider because I think all of these factors are what the provider is going to be thinking about as they help the patient make their decision. Perhaps also something that should definitely factor in is just this idea of shared decision-m and the patient preference.

[00:29:59]the patient might really be riskaverse and and and really feel strongly about uh some of the things they've heard and want to come off. Okay, that's one. But there will be just as many patients that are riskaverse in the opposite direction of disease activity and flare. So, it's really only you and your doctor can make that decision. And I I think it's important to if you haven't already started the conversation with your provider um certainly um starting it now >> and and continue the same idea. Why do you think are some doctors pulling patients off the medication and some are not?

[00:30:36]>> Yeah, I think it just comes I'm going to I think it comes back to a case by case basis. I I'm going to interpret this question as it's been it has been considered. All of the things have been considered. Um and I know I mean for example I um I have made the decision both ways with my patients but it's only after the the careful consideration of all the factors that we talked about and more. Um but I I think people are worried about something bad happening.

[00:31:03]Uh that's that's the short answer. Um and whether you think it's a higher risk that it happens on the medicine or whether you think it's a higher risk that it happened off the medicine. So I think ultimately it comes back to a case by case basis.

[00:31:19]>> Thank you.

[00:31:21]>> Um you'll you'll like this set of questions. So like many of our patients they they might sense that their doctors are unsure um how should they approach that conversation with their doctor?

[00:31:37]>> Um I think there there'll be two different situations here. You will have a conversation with your doctor and when the doctor explained their thought process and all the factors they've taken into account the pros and cons, benefits and risks and then finally they come with the recommendation of either stopping or continuing. Then you feel that they're secure about that and they are taking into account all your individual factors and make a recommendation for you. So they are not basing their recommendation just because of what's happening. And I think that's important. But if you do feel or your doctor is uh telling you that they are unsure about what to do uh and they might the doctor might say well let's just stop because because of the problem. So that may not be appropriate because uh this conversation this shared decision did not happen. So if you are unsure about it or your doctor seems to be unsure be honest have a conversation and ask your doctor what are your thoughts? Do you think that based on my history, my situation right now, I should continue or should I stop? And if after that your doctor continue to be unsure, then maybe you can bring it up that there are resources that your doctor could reach out to and discuss your case. So there are specialists of escalitis that have a lot of experience with this drug and treating uh patients with this diseases that may be helpful.

[00:33:05]So uh talking to any of the vasculite specialist in relation to the specific case might be helpful. So that's one approach. Knowing what's going on in more details, looking for information if just the media or more about the medication itself, reading more about the studies. Uh these are some resources that can be used as well. But I think the main thing is reach out to a specialist. It comes down to the second question I guess. should I see a vasculariz specialist or not? I mean, obviously that's your individual decision, but if uh you're still in the middle of trying to make a decision that is so important and and it may impact your treatment in a very significant way and then maybe that that's a good idea and then discuss this question with a vascular specialist whether is your doctor or you as a patient coming for a second opinion. So I I I don't think that there's a bad idea in a [clears throat] situation that is so uh unknown right now.

[00:34:12]>> I concur.

[00:34:15]>> So for you Dr. Brian a little bit about the future and some concerns with that and I'm sure uh a lot of people are very concerned about that. Could a vacuum ban be pulled from the market suddenly?

[00:34:31]Yeah, it's a very difficult question.

[00:34:33]Uh, again, I don't know. Um, probably not. I mean, stay plugged into the situation and stay informed and in that case, I don't think I think you avoid the suddenly situation. Um, but you know, it it it's up in the air and they're going through the regulatory process. Regulatory processes take time.

[00:34:52]Um, and I, so I think there is a timeline built into this that patients can pay attention to and providers can pay attention to. So, you know, I think the likelihood of it being pulled off the market tomorrow is low, but um, I I think I reserve the right to say I don't I I don't know and I can't predict the future and we we will see. I think that leads into the second question here.

[00:35:16]What happens if insurance stops covering it? Um, again, it's an it's an unknown.

[00:35:22]It's a bridge we're not to yet. Um, you know, it it I think working backwards. I like how Alex presented it earlier in that in this step-wise fashion. Um, where you have a trial um it leads to approval and it's that approval that gets insurance to um to approve it. I'm adding that last step here. So it, you know, if the approval is removed formally, then insurance will stop covering it because it won't be an approved medicine anymore. Um, what happens in those settings it is unclear.

[00:35:57]Um, and we'll just have to stay plugged into the situation. Um, but we are we're a ways off of of that it seems with the information we have at hand. Um, and I we hope that forums like this as well as new information that comes up can help inform, you know, future scenario planning.

[00:36:18]And I don't I don't really have comment on alternatives if it's withdrawal. And I think that's a little bit premature at this point. I I I don't know if you've got comment on that, Alex. It's just a very difficult scenario to to uh predict right now. I would hate to offer um al alter inappropriate alternatives you know >> yeah I agree I think it goes back to the discussion of each individual with their own physician so alternatives will uh also fall into that category that it depends on your case on your disease status and what's the situation so I don't think that there is one here answer >> yeah yeah I think that's appropriate sorry we can't answer that, but it's it's a diff that's a difficult one. All right, moving on. I just, you know, again, we've I think we've made the point pretty clear that you really need to consult with your healthcare provider before making any changes. Um, we at the Vasculitis Foundation, both the board of directors and the staff are committed to um education and providing for our community in a transparent, accurate, and timely way. Um, and we just ask that you continue to follow us and reach out with questions and um, and stay tuned as new information comes up. The next steps um, are that the FDA has opened this public comment period until the end of June. You can see the date there, June 29th, 2026.

[00:37:50]Um and really anyone patients interested parties, organizations or otherwise are encouraged to submit their comments as they see appropriate. It might be that Amjen requests a public hearing to kind of further this regulatory process with the FDA to address the concerns that have been raised, but you do have our commitment at the at the VF that we will of course continue to follow the situation and keep the community informed.

[00:38:19]Um and with that I just thank everyone for attending today. We had a robust turnout over a hundred participants. Um we we thank you for sharing the lunch hour with us today and hopefully this was uh was helpful for you. Um look for the post webinar um uh the posteinar email from the VF for for feedback. And I guess at this point I'll turn it back over to uh to Joyce. Great. Uh, thank you again Dr. Byum and Dr. Villaforte for sharing your time and your expertise. Um, I want to thank everyone for joining us today. We understand this situation may feel uncertain, so we will continue to bring uh updates as we can.

[00:39:04]Um, when today's webinar closes, all of the attendees will receive a popup survey. Please take a moment to complete the survey when where you can add questions you may have had that were not answered today. I wanted to reiterate that a recording of today's webinar will be available on the VF YouTube channel following post-p production work. As a reminder, you will receive an email with the uh the link and additional resources and also information on how to submit public comments to the FDA. I'd like to uh I know Dr. Broom has touched on this, but please share your comments uh with the FDA. Um the portal is open till June 29th. If you're worried, you can submit your comments anonymously if you wish.

[00:39:51]Um but we'll send you the link. And again, I would just like to thank all of you for attending, for being part of our community, and have a good day or evening if you're in Europe. Thank you again, everyone. Have a take care.