Good morning and welcome to Sarepta's conference call to host analyst Q&A regarding the LGMD program. As a reminder, today's program is being recorded. At this time, I'll turn the conference over to Doug Ingram, CEO. Please go ahead. Thank you very much. Thank you all for joining us today for this quick update to address some questions that have arisen in the last 24 hours. We'll be making some forward-looking statements today, so please refer to our public filings for the risks and uncertainties that are associated with making predictions about the future. In a moment, we will take Q&A, and our President, R&D and Technical Operations, Dr. Louise Rodino-Klapac, is available to answer your questions. First, let me make a few clarifying comments. We understand that there's been some questions regarding a fatal serious adverse event in a trial for SRP-9004, an investigational candidate to treat LGMD type 2D. We did not discuss this matter in our call on Wednesday because it was neither material nor central to the topics at hand on Wednesday. This event occurred in a trial that was otherwise completed with all dosing and for a therapy for which we determined, independent of this, not to proceed. Our usual practice is to share these types of findings in the context of a complete study and its results at an appropriate medical meeting, and we intend to do this when the full data set is available. Let me also clarify a few points. The difficult decision to proceed with our most advanced LGMD program, SRP-9003 for limb-girdle type 2E, but to discontinue the remainder of our LGMD programs and to look to partner or out-license them did not relate to a safety event in any of the LGMD trials or because of general signals of ALF and ALI and AAV-mediated full infusions of a later stage in more debilitated patients. As we discussed on Friday, we've had to largely deprioritize our gene therapy portfolio in favor of our siRNA platform based on their relative risk-adjusted NPVs and the need to focus our pipeline and to cut our expenses to manage our liabilities in the context of conservative estimates of performance. Second, let me address whether this changes the approach to Elevidys. The event occurred in a late-stage nonambulatory 51-year-old patient with another therapy. As we know, and as has been communicated to the patient community, to the physician community, and to the FDA, there is a rare risk of ALI becoming a fatal acute liver failure in more debilitated nonambulatory patients receiving Elevidys. This signal is not changed by an event in a late-stage nonambulant patient receiving a different AAV-mediated gene therapy. Indeed, as you are aware, in light of the signal that we've seen, we have taken a very conservative decision already to pause all shipments of Elevidys for dosing in the nonambulant population while we develop a protocol for and obtain data regarding the use of sirolimus as a prophylactic immunosuppression in that patient population. Insofar as we have already paused dosing in the nonambulant patients for Elevidys, and this event creates no new or changed signal, we do not believe that the position of the FDA regarding the Elevidys label would change. In fact, this event occurred about a month ago. The FDA has had all of this information for weeks, and we have received no change from the FDA in their position. With that, we will open up the call to questions. Thank you. As a reminder, to ask a question, please press star 11 on your telephone and wait for your name to be announced. To withdraw your question, please press star 11 again. We ask that you please limit yourself to one question. One moment for our first question. Our first question comes from the line of Anupam Rama with JPMorgan. Your line is open. Please go ahead. Hey, guys. You just hosted a conference call on Wednesday outlining the strategic initiatives and restructuring of the company. You talked about how the limb-girdle patient death has been known for about a month or so. Can you outline the thinking and considerations around the disclosure strategy here? Thanks so much. Sure. Thank you very much for that question, Anupam. The normal approach to discussing clinical trial results would be in the context of all of the data. We don't have that data yet. As it relates to Wednesday, this wasn't salient to our discussions on Wednesday. Let me just explain why. First and foremost, one might wonder about the decision to stop all but the limb-girdle 2E program with SRP-9003. That decision related to the risk-adjusted NPVs of the various programs is a painful decision because we think much of our limb-girdle gene therapies, our goal is to out-license or partner those therapies, but it did not relate to any safety event that we've seen. Of course, looking at these programs requires that one look across both the safety and efficacy of the programs. Second, as it relates to Elevidys, this doesn't change in any way either the safety signal for Elevidys or the approach that we're taking with Elevidys. As we previously discussed, both with the physician community, with patients, with the investors, and with the FDA, we have seen a very rare but serious signal of elevated liver enzymes becoming acute liver failure, that it's fatal in nonambulatory later-stage patients. Nothing about this therapy and seeing it in a 51-year-old nonambulatory patient would in any way change that signal. More than that, I'm sure you all remember, we actually took a very conservative approach with respect to Elevidys, and we determined after our second event to pause all dosing of nonambulatory patients while we developed the protocol, which we have done for sirolimus, and then gather the appropriate information about the use of that before we consider beginning to ship Elevidys for the treatment of nonambulatory patients. As it relates to the Wednesday event, it simply was neither material nor relevant. Of course, it's a separate therapy. It's a separate disease state. It's a separate construct and even a different manufacturing process. Thank you very much for your question, Anupam. Thank you. One moment for our next question. Our next question is going to come from the line of Brian Skorney with Baird. Your line is open. Please go ahead. Yeah. Hey, good morning. Thanks for taking the question. Obviously, sensitive to the last few months devolving into a bit of a hubbub situation that's difficult to navigate from a management perspective. It seems very clearly that this was a material event, especially in the context of shutting down the LGMD programs, even if you aren't explicitly taking that into account in the NPV calculation. My colleague even asked specifically about the safety of LGMD on the call the other day. I guess the question is, where do you kind of view materiality of safety events right now? I would just kind of say if there was an ambulatory death in the DMD setting, I would just want to reiterate that I think this would be a highly material event for you, and you need to be transparent with that immediately. In terms of questions, can you give any other context around this patient specifically? It seems like maybe one of the more older patients that have been dosed with AAV, a 51-year-old. Just thoughts on dosing older patients with Elevidys. How many patients have been dosed in this 2D study? Was the FDA formally advised of this patient's death before the correspondence indicating that a black box update to the Elevidys label is sufficient to address the ambulatory population? Thanks. Thank you very much, Brent. I'll leave much of those questions to Louise. Let me answer the materiality. Again, I want to be very clear. The decision to cease the limb-girdle programs didn't relate to this or another event. They related to the risk-adjusted NPV in the context of our ability to meet our liabilities and remain a viable organization. They were very difficult decisions, but they were the right decisions to make for the organization going forward. As it relates to materiality, certainly, if there was a material change in the safety signal of one of our marketed therapies, we would disclose that publicly. I think we have a, I believe, a very laudable history of being extraordinarily transparent, not only with the physician and patient community, but with our investor base as well. This event occurred in the context of a clinical trial for a program that, for independent reasons, was ceased. There was no additional dosing to be had in this trial. The discussion of this event should occur normally in the context of the entire study results in an appropriate medical meeting, which is our plan. There really was no read-through or change in the safety signal of a marketed product from the results of this study. That kind of explains our thinking. We had a lot to discuss on Wednesday, obviously. Louise, you might want to answer some of the other questions that Brian's asked. Yeah. Sure. The question was around a little bit more detail around this case. This was a 51-year-old nonambulatory LGMD 2D patient. This event occurred about a month ago, which is approximately 11 weeks after dosing. He was in a four-patient phase I trial for the study. The dose was 7.41E13, so high E13 range. This was a 69-kilogram patient. The course in terms of the ALF was similar to what we have seen in the previous two cases with the DMD. Just on the FDA being formally advised of the patient's death. Yes. The FDA was informed first about this case in terms of a life-threatening event and then followed up with the death. The FDA was properly informed along the way of this case. Thank you. One moment as we move on to our next question. Our next question comes from the line of Tazeen Ahmad with Bank of America. Your line is open. Please go ahead. Hi, guys. Good morning. Thanks for taking my question. Doug, I just maybe want to backtrack a little bit to Elevidys and sort of perception among parents as more news flow happens. Today's update is not about Elevidys. It's about limb-girdle. I'm just curious about how the company is thinking about the processes that you would use going forward in order to get parents comfortable with making an appointment or continuing on with the appointment that's being made for dosing. In relation to that, can you just clarify again if there have been any liver enzyme elevations seen in the ambulatory population that's been dosed so far, or has anyone needed hospitalization post-treatment in the ambulatory setting? Thanks. We certainly see elevated liver enzymes in the ambulant and the nonambulant patient population. In a commercial setting, while we don't have the exact numbers, you know there may have been hospitalizations. I have not currently lived the exact number. We have not seen in the ambulant populations the serious event that we're talking about with respect to the two prior events or this event. As it relates to the way we communicate, the goal in our communication with physicians and patients is to arm them with appropriate and factually accurate and balanced information so that physicians and their patients can make intelligent risk-based decisions about this therapy. Thank you. One moment as we move on to the next question. Our next question is going to come from the line of Gena Wang with Barclays. Your line is open. Please go ahead. Thank you. Just wondering, when the FDA gave you the technology platform designation, did they see the limb-girdle death, or were they aware of this? I know we already asked on Wednesday, but in the case of, you know, another, say, unfortunate event in the ambulatory patient, what is your expectation for the label part? You know. It's very difficult to speculate on the latter part of your question other than to note that we have agreed with a black box warning that applies more generally than it applies to ambulant, certainly, which is that we have seen cases of ALI, and we've seen serious cases of acute liver failure resulting in death. That is all warned in the box label that will come out when we supplement the label with the FDA. Of course, we've gotten that information out to the physician community in advance. Louise, do you want to touch on the platform designation? Sure. The platform designation that we received was specifically for LGMD 2E or SRP-9003, and that's specific to the manufacturing process, which is the adherent manufacturing process. It's very specific to manufacturing in SRP-9003. Thank you. One moment as we move on to our next question. Our next question comes from the line of Salveen Richter with Goldman Sachs. Your line is open. Please go ahead. Hi. This is Mark on for Salveen. Thank you so much for taking our question. A couple from us. Have there been any other patient deaths on any other of your AAV gene therapy programs? Also, regarding the manufacturing process for the LGMD drug here, is the process similar to process B for Elevidys? Also, were any of the LGMD patients on a background therapy like corticosteroids? If you could speak to that, please. Thanks. Yeah. I'll answer this one, Louise. You correct me. I think I got all of them. I think the first question was, are there any other fatalities associated with any of our other gene therapy trials associated with the therapy itself? The answer to that is no. On the manufacturing side, that's a different manufacturing process for SRP-9004. That's a suspension process. Elevidys is an adherent process. I apologize. Louise, do you recall the third question? Yeah. The last question was on, was the limb-girdle patient on a background of steroids? Typically, limb-girdle patients are not on standard-of-care steroids, and that was the case here. They do receive our standard protocol of starting prednisone prior to treatment and then continuing for 60 days. That's the protocol that we use with delivery of after infusion. All right, thanks. Thank you. One moment for our next question. Our next question comes from the line of Michael Goelz with Morgan Stanley. Your line is open. Please go ahead. Good morning. Thanks for taking the question. I guess appreciating that this recent event was not in a patient on Elevidys, just curious if you've been able to identify other risk factors in these three deaths so far. Thanks. Yeah. We've continued to analyze all three cases. In all three cases, as you know, and as we've noted, these are nonambulatory, more progressed patients. There's obviously differences in the pathology between DMD and LGMD, but in both cases, we have patients that are more advanced in their disease and are not able to recover from the liver injury as a younger patient would be able to. Nothing more specific in terms of very specific single risk factors that we can point to at this point. Thank you. One moment for our next question. Our next question comes from the line of Brian Abrahams with RBC Capital Markets. Your line is open. Please go ahead. Hi. This is Kevin Quan for Brian. Thank you for taking our questions. Sorry to hear this news today. We just had a question on 2E. Can you talk about whether you believe you might need additional data at this point to support your BLA for that program, maybe using sirolimus or something alike? Do you expect additional feedback from the FDA before filing on that particular LGMD program? Thank you very much. I'll turn this call to Louise. Yeah. For LGMD 2E, we've conducted three clinical trials in that space. Phase 1, our initial dose-finding study, and then we conducted Voyaging, which is in older and nonambulatory patients, and then Embragine, which was a 17-patient. We did not use our standard steroid protocol, and we did not use sirolimus in those studies. This is something that we'll continue to evaluate as we submit the BLA in terms of the use of any recommendation for potential use of sirolimus. Thank you. One moment for our next question. Our next question is going to come from the line of Ellie Merle with UBS. Your line is open. Please go ahead. Hey, guys. Thanks for taking my question. I guess just based on the clinical experience of Elevidys in ambulatory patients, what would you expect for the rate of patients being hospitalized for LFTs in ambulatory patients in the real-world setting? What would constitute a deviation from this rate? Lastly, I know a couple of people asked about this, but I just want to confirm that there are no other additional patient deaths that we aren't aware of currently across either the clinical trials or the real-world setting. Thanks. Yeah, I can turn the first part of the question over to Louise, and I can confirm the second part of the question. Yes. A few comments on the incidence of liver enzyme elevation. We've talked that this is approximately 30% to 40%. Just to clarify in terms of clinical trials versus the real-world thing. In clinical trials, we obviously have in-depth visibility into all of adverse events in general across the board, whether it's commercial or clinically. We act with vigilance in terms of monitoring patients. In the commercial setting, reporting is given to us, and we follow up immediately. Approximately 30% to 40% of elevated liver enzymes, a subset of them require the infusion of higher doses of IV steroids, for example, and they will be hospitalized for that. I don't have exact numbers on the commercial side, but we certainly want them to go to the hospital to get increased steroids in that case. We are extremely diligent, whether it's commercial or whether it's clinical, but we're looking for, in the upcoming sirolimus trials, a reduction in that percentage or that number of acute liver injury number, which is 30% to 40%. Understood. Thanks. Thank you. One moment for our next question. Our next question comes from the line of Biren Amin with Piper Sandler. Your line is open. Please go ahead. Yeah. Hi, guys. Thanks for taking my question. I understand this is an unfortunate event with LGMD, and it wasn't related to the business update. However, do you believe it had a relevant read-through to Elevidys in the nonambulatory setting, given it is the same vector across both programs? Therefore, you know that information should have been shared. Did your expert committee that evaluated the nonambulatory side for Elevidys, did they evaluate this event when they were making that recommendation for an enhanced immunosuppression regimen? Last question, with this event, how do you think this will shape your discussion with FDA on the nonambulatory side of things with Elevidys? I would say I don't believe there's read-through to Elevidys for a number of reasons. One, of course, a different therapy, different construct, different dosing, different manufacturing process. Also, even if it did have read-through, it would be read through to a signal that we've already fully appreciated and disclosed and know about, which is this rare risk of ALI becoming a fatal ALF. I don't see it as having read-through to Elevidys properly contextualized. As it relates to the approach to Elevidys and the immunosuppression regimen, I don't think this changes because it is a similar signal. What we've done here, and I think it's appropriate but very conservative, we've chosen not to ship Elevidys for the use in the nonambulatory patient population until we explore the use of sirolimus as a prophylactic immunosuppression. We have very good preclinical data and some anecdotal clinical data that would suggest that this could significantly reduce the risk, and we'll proceed with that. Our hope is to have conversations with the FDA about gathering that data as soon as possible. Thank you. One moment for our next question. One other thing I do want to remind everyone is that this risk, both of acute liver enzyme elevations and the risk, very rare risk of elevated liver enzymes going on to become acute liver failure, is an AAV class-related risk that is associated with the use of AAV, which obviously is significantly present in the liver, a risk of liver stress that can become something more serious in rare cases. Thank you. Our next question comes from the line of Yanan Zhu with Wells Fargo. Your line is open. Please go ahead. Great. Thanks for taking the question. Could you give us a sense of how many LGMD patients across all genotypes have been dosed and how many are ambulatory versus nonambulatory? I was wondering, you know, the rate here appears to be higher than the DMD nonambulatory cohort that you have treated. You know, wondering whether the liver enzyme signal is more prominent in this disease in general, which therefore could explain the higher rate, or any thoughts on any disease-specific reason to believe that DMD could be a little different, could be different than LGMD. Thanks. Yeah. I'll turn this over to Louise. Before I do, I'll just comment that it is very difficult and probably suspect to draw signals based on a single event. With that said, Louise, do you have thoughts on this? Yeah. In terms of patients dosed across the LGMDs, I don't have the exact number, but between 35 and 40 patients dosed across our trials. In terms of ambulatory status, approximately, I would say 50/50, maybe favoring slightly the ambulatory patients across these trials. It was a wide spectrum of patients dosed. In terms of numbers, I agree with Doug. This is a rare signal. With small numbers like that, it's difficult to make an assessment of a% in that small number of cases. We do know that this is a rare event, and you can just point to the DMD population for that. Thank you. One moment for our next question. Our next question comes from the line of David Hoang with Deutsche Bank. Your line is open. Please go ahead. Hi. Thanks so much for taking my questions. I just wanted to ask about, could you just refresh us a little bit on the market opportunity that you perceive around LGMD 2E for SRP-9003? In terms of the progression of the disease and the level of receptivity and demand you would expect for a gene therapy product there. Thank you. I am not prepared right now to provide sort of a market update other than to say that it is an ultra-rare disease, but it is a disease that's a very serious neuromuscular disease that doesn't have options. The choice that we've made to proceed with limb-girdle type 2E and SRP-9003 relates most significantly to the fact that we feel a duty to these patients to continue, given how late stage in this particular development. The decision to cease the other limb-girdles, again, was based on the fact that the risk-adjusted NPVs for all of the limb-girdles, including, frankly, 2E, is not as high and is quite low relative to the pipeline that we've now decided to focus our attention on. Thank you. One moment for our next question. Our next question is going to be from the line of Kristen Kluska with Cantor Fitzgerald. Your line is open. Please go ahead. Thank you. Can you give us a sense of whether there have been any other life-threatening events observed either clinically or commercially beyond the three that resulted in fatalities? Louise, do you have a comment on that? We are not. We do not have any or are unaware of any. Thank you. We'll move on to our next question. Our next question is going to come from the line of Andy Chan with Wolfe Research. Your line is open. Please go ahead. Hey, thank you for taking the question. Another question about Elevidys. Can you please remind us of how the recent event in the past two months or so would affect your collaboration with Roche? Are there terms or conditions in your agreement, for example, milestones that would be affected by the recent events, or are they all based on quantitative sales? Thank you. They're quantitative, and I don't envision that it has an effect on any of the contractual terms of the agreement. Thank you. One moment for our next question. Our next question is going to come from the line of Sami Corwin with William Blair. Your line is open. Please go ahead. Good morning, and thanks for taking my questions. I was curious if you think that these recent deaths, all occurred in nonambulatory patients, could impact the label for SRP-9003 and if that may be restricted to only ambulatory patients. As you were conducting your risk-adjusted NPV to determine the prioritization of your pipeline assets going forward, were you assuming you would be able to commercialize SRP-9003 in ambulatory and nonambulatory patients? Thank you. Yeah. As to the second question, the answer to that is yes. Yes. The NPV that we performed across our limb-girdles made that assumption that we'd be able to make them available both ambulatory and nonambulatory. Louise, do you have any thoughts on the first part of the question? The restrictions in the label potentially? Yeah. As I mentioned, we've dosed a wide range of patient ages and weights across 2E. As we submit the BLA, we're evaluating whether we make any recommendations on sirolimus, but none of our clinical trial patients were on sirolimus at the time. Great. Thank you. Thank you. One moment for our next question. Our next question comes from the line of Kostas Biliouris with BMO Capital Markets. Your line is open. Please go ahead. Thanks for taking our question, and sorry to hear the news today. Would you expect the third death to increase physician hesitancy with Elevidys? Do you see any impact from today's update on the $500 million floor that you have set for Elevidys? Thank you. The answer to both of those questions is no. Properly contextualize this. Again, this event, tragic for the family involved, related to a different therapy, related to a very debilitated 51-year-old nonambulatory patient. Even if there was read-through to Elevidys, and there are lots of caveats to that, given that it's a different therapy, different manufacturing process, different constructs, different dosing regimen, very different patient. This is a 51-year-old patient. You don't see that with Duchenne. It still would not affect the change in the signal. We know there's a signal of very rare ALI becoming a fatal ALF with Elevidys, and that's well understood. It should affect neither properly contextualize the Elevidys ambulatory patients and their considerations, nor does it affect our stress test, the $500 million stress test. Thank you. One moment as we move on to our next question. Our next question comes from the line of Ritu Baral with TD Cowen. Your line is open. Please go ahead. Ritu, your line might be on mute. Apologies. Thanks for taking the question. I want to rip through a couple pretty quickly here. Doug or Louise, you mentioned that this patient was on a background medicine, but it wasn't a steroid. Can you elaborate on what background meds this patient was on? As you think about this hypothesis that we discussed last time, which was the issue of liver fat, liver fat levels, etc., contributing, are there data points that contribute to this given the patient's age? I've got one more follow-up. Louise, you want to take both of these? Yeah. Just quickly on that, I think there was a misunderstanding there. This patient was not previously on any background meds in terms of steroids. They started steroids right before dosing, continued for 60 days, and then were adjusted thereafter. There was no background previous dosing. Oh, I meant background other than steroids that could have contributed. No. No. No. Okay. The liver fat? Yeah. I mean, we're still evaluating specific things that we can point to. All we can say at this point is that it occurs in these or has occurred in nonambulatory patients that are more severe and certainly may have less resilience in terms of the liver being able to recover. We don't have specifics that we can point to yet. The issue of what you are tracking to measure risk, is there something, is there a better idea with this third case of what to track? Is it the standard definition of Hy's law? Is it like Hy's law with GGT? Is it something established, or is there a unique profile that is emerging in the liver function test, the liver enzyme parameters? How long are you monitoring this for, given this is 11 weeks and the others, I believe, were earlier stages? Is there a protocol amendment to monitor all trial patients, clinical patients now out to three months, four months? How should we be thinking at the panels and the timing? Yeah. The monitoring occurs throughout. Even though the death occurred, liver enzyme elevations start to occur earlier before that. Certainly, patients are monitored continuously, and our physicians are diligent about that. In terms of what to monitor, all liver enzymes are elevated. GGT and bilirubin are the most reliable in terms of monitoring because AST and ALT are already elevated in both DMD and the limb-girdle. All of them are monitored consistently and usually rise together. It is a collection of those liver enzymes. Bilirubin, obviously, is a strong marker in terms of showing whether or not it's progressing to ALI and ALF. Is monitoring HIS law useful in this case? I mean, we certainly, you know, ALT is monitored, but that's just part of the calculation from the liver enzymes. We're looking at all of it. You know, we don't look at a single biomarker. We're looking at all of them. Thank you. One moment as we move on to our next question. Our next question comes from the line of Mitchell Kapoor with H.C. Wainwright. Your line is open. Please go ahead. Hey, everyone. Since you're using the same vector across the pipeline, how confident are you that we won't see additional deaths due to Elevidys or the LGMD 2E products? What would be the timeline and process of disclosure of events going forward now that we know what we know on timelines? Could you expand on how this would differ in the clinical trial setting versus the real-world setting? There is a known real risk of elevated liver enzymes becoming acute liver failure fatally in more debilitated patients. It's always been in the nonambulatory patient. If that signal changed, we would certainly communicate any change in that signal. Thank you. One moment. I want to just point out again, I think this is an AAV class risk generally. We've seen this across not just our program, but other programs. One knows that with respect to AAV-mediated gene therapies, particularly in the full-body infusion situation, there is always a very rare risk of this that we've now seen emerge this year with Elevidys. One moment for our next question. Our next question is going to come from the line of Joe Schwartz with Leerink Partners. Your line is open. Please go ahead. Thank you. I'm going to ask a question which is similar to the one we asked on Wednesday, and that is if you could please help us understand the overall numerical extent of hospitalizations due to ALI and ALF and their pattern over time for the company overall. It would be extremely helpful to have some color on what the denominator looks like in terms of the patients who have been hospitalized for ALI and ALF and have been discharged, as well as those who haven't, and how these things have been trending, even if it's just qualitative, since hospitalization definitely seems like a leading indicator. We're all trying to gauge where we are in terms of the mortality trend and whether it has peaked yet, or if not, when we might be on the backside of this unfortunate trend. Louise, do you want to touch on this? I just want to come back to the difference in monitoring in the clinical trial setting versus commercial setting. We're diligent across the board in terms of clinical and commercial. Clinical, we have more insight into SAEs as they are brought in. Commercial, we certainly will get reports, and we follow up and make sure that we are following up extensively. In terms of the numbers of hospitalizations, I think it's important to note that we encourage patients and physicians to hospitalize with increases in liver enzymes so that they can get the proper increased steroids, etc., for that. We know that of the, we know 30% to 40% have elevated liver enzymes, a subset or lesser subset of those have acute liver injury, and then a very small percentage, somewhere less than 10%, approximately 5% may require hospitalization. In terms of percentages, that's the information that we have. Thank you. One moment for our next question. Our next question is going to come from the line of Gil Blum with Needham & Company. Your line is open. Please go ahead. Thanks for taking our question. I don't remember if we discussed the timeframe in which the Elevidys events unfolded, but just given the timeframe here of 11 weeks, does this change your thinking around the study that's being designed with sirolimus? Thank you. Now, this is consistent. These cases with our design of the trial, experts had access to all three cases and took that into consideration. There is no change in our design, and it's consistent with potentially preventing what was seen in these cases and preventing ALI generally. This is based on experience of many across the field in terms of preventing the elevation of liver enzymes. We have confidence that we'll do so. Yeah, the confusion is just the confusion is the death was seen at 11 weeks, not the course of the increase in liver enzymes that's followed the same course as the other cases. I just want to make it clear because I think that's where the misunderstanding is coming from, that you're thinking that you're seeing this post that we're saying the death occurred at 11 weeks. Gotcha. Thank you. Thank you. One moment for our next question. Our next question comes from the line of Andrew Tsai with Jefferies. Your line is open. Please go ahead. Hey, thanks for taking my question. Just to reconfirm, you mentioned FDA had the information for weeks. There's no change of the position. Just to reconfirm, it was before or after the FDA had agreed to a black box warning for Elevidys and ambulatory DMD, just gauging the FDA's level of comfort with these deaths. Thanks. Yes. Yes. Yes. FDA was made aware of the case as a life-threatening case and then followed up with the notification of the death. They have been aware of this throughout our conversations about the label. Thank you. One moment for our next question. Our next question is going to come from the line of Louise Chen with Scotiabank. Your line is open. Please go ahead. Hi. Thanks for taking my question. I wanted to ask you, I know it's a different disease, but have you received any physician feedback on the headlines related to limb-girdle? Do you plan to just give a general safety update to all the physicians that are currently prescribing Elevidys in regards to LGMD? Thank you. Again, this does not affect the new safety signal. We have already provided to physicians the fact that there is a rare but serious risk of elevated liver enzymes becoming a fatal acute liver failure (ALF). We've seen it in two cases with Elevidys. More important than that, perhaps, is the fact that we have chosen not to ship for the nonambulatory patient until we get more clarity on the use of sirolimus and we get data on the use of sirolimus and we can evaluate that risk-benefit in the context of the use of sirolimus. In terms of communication on this case, as mentioned, we've communicated with FDA, and then we have communicated with the physicians in these trials on this case, prioritizing communication with our physicians conducting these trials. Thank you. One moment for our next question. Our last question is going to come from the line of Gavin Clark-Gartner with Evercore ISI. Your line is open. Please go ahead. Yeah. Doug, you noted earlier that you would disclose a material change in the ambulatory Elevidys safety profile to the investor community. I'm just curious how this materiality threshold is decided and who determines that. It is decided based on facts and circumstances, obviously. We are, I think, historically a very transparent organization. If there was a change in the risk profile of Elevidys, we would first and foremost share it with physicians and patients, and then, of course, we would share it with investors. Thank you. I would now like to hand the conference back over to Doug Ingram for closing remarks. Thank you all very much for your questions. I do apologize for the fact that we had to have this update to clarify some things. With that, I would ask everyone to have a good weekend. This concludes today's conference call. Thank you for participating. You may now disconnect.