Good day, and thank you for standing by. Welcome to the Disc Medicine Corporate Call. At this time, all participants are on a listen-only mode. After the speaker's presentation, there will be a question and answer session. Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker today, John Quisel, Chief Executive Officer. Please go ahead. Great. Good morning, everyone. Thank you for joining. We're here today to discuss the regulatory update for bitopertin. But before we get started, I'll mention that we will be making forward-looking statements, and these should be taken in context with respect to materials that we filed with the SEC and posted on our website. So I'll start by saying I wish we were here today discussing better news. As you all saw last Friday, we received a Complete Response Letter from the FDA, noting that, while in their view, there's sufficient evidence that bitopertin significantly lowers protoporphyrin IX, or PP9, there was uncertainty in the regulators' minds about whether the reductions in PP9 were, quote, reasonably likely to predict a clinical benefit. And as we'll talk about in a minute, that's the standard for an accelerated approval, is to meet those two prongs. So, you know, Disc has been committed to bringing bitopertin to patients as quickly as possible, because we believe in the potential of this program and the importance of a potential disease-modifying therapy for the EPP community. We are deeply disappointed that this isn't happening today, but our commitment to bringing this program forward and pursuing an approval has not wavered. We believe the issue raised in this Complete Response Letter, or CRL, is readily addressable with the results of the ongoing phase II APOLLO study. As you'll hear more today, we're delighted with the progress and rigor of that study. We expect data from in Q4 this year. So, you know, we look forward to working closely with the FDA to support their review, and we're pursuing all avenues to support approval. So on this slide, we've summarized the details of the CRL. The full letter has also been published by the FDA on their website and by Disc in a Form 8-K. And it's remarkable actually to see this level of transparency. I think it's a new standard in the availability of these complete response letters to the public, and we're actually proud to be part of that. So I'm not going to rehash all the details here since it's all available to be read. Pretty brief letter. It's clear, and we believe readily addressable by completing and submitting the results of the phase III APOLLO trial, which, as I mentioned, is well underway and progressing very nicely. This next slide is data from ourp hase II AURORA study. This was central to the regulatory review. This data has been presented extensively at scientific conferences and is now published in the Journal of the American Academy of Dermatology. This slide provides a brief summary. I'm not going to go through it all again in detail, except for a few highlights. You know, I do want to note that we hit our primary endpoint of protoporphyrin IX reduction with high degree of statistical significance. And as shown on this slide, there was evidence of improvement in several endpoints that were designed to measure clinical benefits. There's a light blue line that shows an increase in placebo-corrected time in light, and below that, on the same timeline, is shown with red hashes, the phototoxic events. I think that phototoxic event bar is probably the most remarkable data showing the reduction of phototoxic reactions in the 60 milligram dose group, the complete elimination of those attacks during the second half of the study. And there's, you know, a clear temporal relationship between the reductions in PP9 and the improvement in these clinical endpoints. I guess this was our view of the data. However, this study was powered to look at the protoporphyrin IX reduction, and these other endpoints, the so-called clinically meaningful endpoints, some of them were statistically significant, and some of them were not. And this is what probably created the room for debate on whether we'd satisfied the standard for accelerated approval. So to talk about that standard for a moment, there are the two prongs. You have a surrogate endpoint, in our case, protoporphyrin IX, which has been noted as being mechanistically compelling. And the obligation is to achieve a clear statistical reduction in that biomarker, which we did, and that was acknowledged. The second prong of the analysis is whether that reduction in the biomarker is thought to be reasonably likely to predict clinical benefit. Now, this is a very broad standard, subject to a lot of different interpretations. And I guess, you know, I think it's also remarkable to note, as I'm going through the data, the stories in the media from patients about, you know, real changes in their lives, people going on beach vacations with family, spending time on boats for the first time in their lives. Really very moving stories of recovery from a devastating disease. We know now from the Complete Response Letter that the FDA did not ultimately feel that these lines of evidence met the current standard of, quote, "reasonably likely to predict clinical benefit", for the purposes of the second prong in achieving Accelerated Approval. I guess the policy debate about Accelerated Approval has been going on for years, both in prior administrations and the current administration. I think it is fair to say that recent decisions have indicated an increasingly stringent approach to this question of when an Accelerated Approval is appropriate. We, as a single biotech company, we can't set or meaningfully influence this policy. It's our job to do our best to bring promising therapies to patients as quickly and safely as possible. We will continue that mission now by focusing on the phase III APOLLO trial, which we hope will deliver inarguable evidence of the safety and efficacy of bitopertin for the EPP patients. If we're successful in this, we'll be seeking approval through the traditional route rather than this accelerated route. So looking forward then, this slide shows the APOLLO trial overview. I think that is the next big question, what to expect from this important trial. We are happy to say that enrollment enthusiasm has been high, very high, in fact. And the trial will be fully enrolled in March, which is several months sooner than we'd expected. This means that we will be able to have, or we expect to have, top-line data in Q4 this year. As a reminder, this trial is a randomized, double-blind trial designed to measure both PP9 reduction and improvement in sunlight tolerance as co-primary efficacy endpoints. We reviewed and aligned with FDA on this trial design at both our end-of-phase II meeting and Type C meetings that were held in 2024. We're confident in this trial design for several reasons. The primary endpoints are robust and clinically meaningful. We have demonstrated statistical significance on protoporphyrin IX reduction in two studies now, both BEACON and AURORA in phase II. And our light tolerance co-primary endpoint was designed by taking into account all of the learnings from our phase II program, as well as bitopertin's mechanism of action and the behavioral dynamics that were noted in the AURORA study. We also have a very strong study design, which includes rigorous assessments of baseline light tolerance during screening, which we learned was an important feature. And we've also introduced now stratification by geography, and these are both set up to minimize confounding factors in our analysis. The APOLLO study is also well-powered, and we're happy to share that we have completed a blinded sample size recalculation of time and sunlight data that showed no increase... no need to increase sample size. So that's a lot of jargon. That means essentially the variability in our endpoints that we used to design and power the study appears to be sustained so far in the first 50 completers for the study so far. So actually, really good news there in terms of the way this study has come together in terms of rigor and our ability to capture reliable data sets. So we're very excited about this study. We have a lot of confidence in the design and chosen endpoint, and we'll look forward to sharing the data from it in Q4 this year. So in this next slide, to spend a little more time on the APOLLO endpoints, we have two co-primary efficacy endpoints. The first looks at the amount of time that patients can spend in light on a longitudinal basis, letting us evaluate improvements over time on therapy. The graph shows how bitopertin performed on this endpoint in the AURORA trial, and you can see that there is, and this is, you know, important to note, this is a post-hoc analysis. But, you know, had we designed the study this way, there would have been a significant difference between versus placebo. When you look at the time points after we know that PP9 has reached its new low point and after the placebo effect, which is marked in the first couple of months of the study, has waned. This endpoint showed statistical significance in the AURORA trial, despite only having 25 patients per arm, and it accounts for the amount of time it takes for the PP9 lowering effects of bitopertin to occur. So this endpoint has a greater than 80% power over a wide range of data scenarios in our 150 patient, two-arm study, APOLLO. So very well-powered trial using these endpoints. Our other co-primary endpoint is reduction in protoporphyrin IX, which we have shown with a high degree of statistical significance in both the BEACON and AURORA trials. You know, 40%, if you look at it, versus baseline, actually closer to 50% if you look at it with respect to the placebo group... So really important reduction here in the disease causative metabolite, PP9, and a high degree of confidence that we will hit that part of the co-primary endpoint as well. So all in all, we feel we have two very strong endpoints here that we expect to successfully demonstrate the clinical benefit of bitopertin and its potential to be a transformational drug for EPP patients. So what does this mean for timing and next steps? We plan to request a Type A meeting to review our approach for resubmission and response to the CRL. APOLLO is designed to demonstrate the clinical benefit of bitopertin in EPP patients. As mentioned, we are on track to complete enrollment of APOLLO in March and present top-line data in Q4 this year. We'll then plan to prepare the package and resubmit. Typically, for a CRL response, the FDA has a goal date of six months for the review, which would put us roughly in the middle of 2027 in terms of when we could expect a decision on a traditional approval basis. So to reiterate, we are confident in this program. We believe that it can set a new standard of care for EPP. This is a debilitating disease that touches patients' lives every day, and so we've made every effort and pursued multiple avenues to expedite the process of making bitopertin available to the EPP community. This decision from the FDA is an unfortunate setback, but we remain committed to advancing the program and working with the FDA to support their review. We've heard stories through the patient advocates, the investigators, and in the media about how certain patients' lives have been transformed by bitopertin. We want to make it clear that helping those patients is our mission, and those who are currently on bitopertin through a clinical trial will continue to receive access to treatment while we respond to the CRL. And we want to thank, you know, really, with deep gratitude, all the people who've made this work possible, most notably the patients, the clinical trial participants, who put their time and their health into, into this research effort. Their families, who have to facilitate this, the broader advocacy community, and the clinical investigators, all of whom have given so much of their time and energy to support this program over the past several years and continue to do so. In fact, without their support, we wouldn't be making this great progress on the APOLLO trial. Okay, so backing up to the overall corporate outlook. You know, I feel that as a company, we are in great shape here to deliver across a wide range of programs. This is a so-called catalyst slide that we've shared before, but with a few changes now, responsive to this update. As I've noted previously, we are expecting top-line data now from APOLLO in Q4 of this year, after which we plan to submit a response to the CRL by the end of the year. With a six-month review period, we would then expect an updated FDA decision in mid-2027. We are also very excited about the other catalysts we have coming this year for our other programs. For DISC-0974, we expect to have additional data from our phase II myelofibrosis study in the second half of this year, followed by... Our objective is to have an end-of-phase II meeting, where we expect to align on the digital trial endpoints with the agencies. And then we're super excited about the third program, DISC-3405. We expect to be able to share initial data from our phase II study in Polycythemia Vera, and we've talked about how the excitement for this mechanism has led to very rapid trial enrollment there. And we've opened up our phase I-B study in Sickle Cell Disease patients, and we hope to have some data from that trial by the second half of the year as well. And all this comes with being in a great financial conditions. We have been, and we will continue to be, highly capital efficient. We do ensure that we're investing in activities that will, we think create a great potential for creating value. And delighted to say that we'll be able to maintain a runway guidance of having cash into 2029. So really well funded to pursue all of the R&D programs that we have here. So that's everything I wanted to run through today. Thank you all for joining the call. We wish we had a better update today, but as I've said, we are committed to getting bitopertin to patients, and we are confident that we have a strong path forward to do so. With that, I will turn it back to the monitor-moderator to open up the Q&A. Thank you. Thank you. Our first question comes from the line of Roger Song with Jefferies. Your line is now open. Great, team. Morning, and thanks for providing confidence despite the surprising CRL. So, maybe two questions from us. The first one is, can you just confirm this pain-free sunlight exposure and the PP9 co-primary endpoint will be likely support the approval? Any indication during the review process, FDA have any different view? And then statistically, given this is a co-primary endpoint, is that p-value of 0.05 hitting both of them will be supporting the approval. Thank you. Yeah, this trial design and the endpoints that were used here have been discussed with the FDA and are aligned with them. And I think, in fact, what we see in the CRL with specific references to the APOLLO trial would suggest that we have continued alignment there. So we're not aware of any change in FDA position on that. And yes, the two co-primaries, the protoporphyrin IX and the time in sunlight during month six, these are independent, and so both need to hit the p-value 0.05. Got it. Thank you. Just one quick one, if I may. In the CRL, they talk about the association between the PP9 and the clinical benefit. Is FDA looking for statistical significance association between the two endpoint, or they just looking at the clinical endpoint, not some of the clinical endpoint, not reaching the specific, so they think you lack of the association? Thank you. Yeah. So the language that's there in the CRL is also all we know about the basis for this non-approval event. So we're speculating in the same way you are, but it does appear that they were, you know, in the end, if not in the beginning, looking for some kind of statistically significant, I guess, relationship between protoporphyrin IX and one of the various clinical endpoints. I'm not sure which one, to be honest. So it's something we'll try to understand better as we continue our interactions. Although, to be honest, it's not... I mean, that's a feature of the accelerated approval path, which at this point is probably irrelevant. Now we'll just be looking to get, you know, stat sig on our two co-primaries in the APOLLO trial. So it's more of a backward-looking exercise to understand what happened here. But right now, really, the CRL is the only information we have. Got it. Exactly. Okay, thank you. Thank you. Our next question comes from the line of Tom Smith with Leerink Partners. Your line is now open. Hey, guys. This is Bulchum Patel. I'm for Tom Smith. Could you please provide additional color on the powering assumptions for the APOLLO trial, specifically for the assumed treatment effect and then placebo response for the primary endpoint, the time and daylight endpoint? Thanks. Yeah. Let me hand you over to Will to speak to that. Sure. So we, as John mentioned, have, in a variety of both variability and effect size scenarios, over 80% power. So, you know, that gives us a lot of confidence in the success of APOLLO. We haven't discussed, you know, the exact numbers that went into specific power calculations. Gotcha. That's helpful. Thanks. And then a follow-up on that, do you plan to propose any changes to APOLLO during the upcoming Type A meeting, as it currently stands? Well, you know, we're still trying to figure out. I mean, this news is really only effectively a business day old for us. So we're trying to figure out exactly how we wanna approach that meeting. We don't have our final plan in mind. Modifying the APOLLO trial is not on the menu, at least as we're thinking about it right now. But I don't wanna. Yeah, I mean, actually, it's just simply not on the menu right now. We feel like it's a robust trial. It's done very well. So I can't see why that would be part of the discussion. But, you know, just to say, generally, we haven't actually sorted out our final approach on that meeting. Sounds good. Thank you for taking my questions. Thank you. Our next question comes from the line of Sean Laaman with Morgan Stanley. Your line is now open. Good morning, John and team. Hope everyone's well. Maybe just to double-click on the last question, John. You know, what specifically will you seek to lock down the upcoming Type A Meeting, you know, regarding APOLLO's endpoint, hierarchy, analysis, populations, and success criteria, especially since you said the diary data can be analyzed in any way the FDA wants? Thank you, John. Yeah. So I do think that's probably the primary purpose of the meeting, is to just make sure that there's not some kind of misalignment around the data package that we'll plan to bring upon successful completion of the APOLLO trial. And to your point, I mean, I guess, you know, on the off chance there is some additional or different data analysis that the FDA has in mind, we believe we're really capturing through our diaries, et cetera, essentially all the information you would want to look at for this patient population. And if there's a different approach that's desired, then, you know, we should be well-positioned to address that as well, with what we think is a pretty... Like, the evidence so far suggests rigorously done and, you know, well-captured data set. Again, I think that's an outside probability. We haven't had any sense of a difference opening up around the APOLLO trial design, but.... Yeah, that is probably the primary thing we think about. Thanks, John. And maybe just one other quick one, I hope. So the FDA called the 40% PP9 reduction at 60 mg relatively modest and questioned whether that magnitude is predictive. What magnitude or threshold or distributional shift do you believe is clinically meaningful, and how will you demonstrate that prospectively in APOLLO and/or via bridging analyses from AURORA/BEACON? Yeah, that was a surprising comment. I think there's a lot of, a lot of good evidence for why our reduction is quite meaningful. But Will, why don't you speak to that? Sure. I think, you know, we look to the data to determine what is a reduction that is meaningful. We've provided before, evidence in the literature of women with EPP who become pregnant and go into remission with about a 40% relative reduction of PP9, experiment in Denmark with kind of a mechanical extracorporeal reduction of PP9 of 30%, leading to very large increases in time and light. We have our animal model data, and, you know, we've shared the results of what happened in BEACON and AURORA, you know, showing light tolerance improvement. So I think our position is the data are telling us that, bitopertin is achieving a level of reduction that has clinical benefits. Wonderful. Thank you, gentlemen. Thank you. Thank you. Our next question comes from the line of Kristen Kluska with Cantor Fitzgerald. Your line is now open. Hi, good morning. Sorry about the news, but appreciate the positive attitude you have here today. Wanted to ask just on your confidence for the co-primary endpoint on time and light without pain, whether or not the FDA will maintain looking just at that final month. And then I think with the AURORA trial, people were probably really excited by the data in BEACON and out of the gate were trying to test whether or not the drug works. So now that we know the onset does take a couple of weeks here for the drug arm, are physicians and KOLs kind of working with patients more to mitigate that high risk initially, just given that it does take some time for the PP9 levels to go down? Yeah. So on the first point, and maybe I just need to be a little clearer because I hear everyone asking, like, oh, is there- is there an issue? Is the FDA gonna change their view on the Apollo trial? I mean, I feel like I can lean in pretty hard on that and say there's just absolutely no evidence of that right now. But of course, we will have this Type A Meeting and report back if there is some something that's opened up there. But truly, I don't see any evidence of that, and I don't even really in the CRL see evidence of that. In fact, to the opposite, I feel like the CRL is essentially pointing to the APOLLO trial as designed, as being the path to getting the dataset that they would view as appropriate for supporting approval. So, you know, just kind of on that general theme, really, we feel good about the way the APOLLO trial is designed and the degree to which it's been vetted with the FDA. Your second question, you know, very interesting question, right? We know it takes a couple of weeks for protoporphyrin IX levels to reach you know, meaningful reductions. And so, Will, maybe you can speak to this question of, you know, how are investigators managing that, et cetera. Sure. So one of the approaches to success in APOLLO that we took was doing things in a similar way to AURORA as much as possible. Of course, our analysis approach is different, given the placebo effect in looking at time after that initial month or so of placebo effect time. But other than that, you know, we have the same diaries and the same instructions. And so we think that's the best path to success, is getting the same type of data that we did in AURORA and analyzing it in the way that we feel at month six is gonna give the best chance to hit that. Thank you. Our next question comes from the line of Tara Bancroft with TD Securities. Your line is now open. Good morning, all. This is Francis on for Tara. Can you just tell us a little bit more about the nature of the alignment you reached before the CRL? You know, what-- Given the recent events, what's your level of confidence in the current alignment with the FDA on the co-primary endpoint, specifically looking at those last four weeks? Kind of how important is total pain-free time and light, given this was the approval precedent for SNAS? Yeah, like I said, in response to the prior question, we feel that it's fully aligned, both in the, I guess, kind of three meetings on the topic, the end-of-phase II in the fall of 2024. Then we had a Type C meeting that was dedicated solely to the topic of the APOLLO trial design, and reached alignment there. In fact, that was kind of where the final alignment was reached. And then there was opportunity in the pre-NDA meeting over the summer.... where there was no issue identified with that, as well as throughout the NDA review, where I think the questions around the APOLLO trial have really just focused on this inquiry into whether it's well underway and how rapidly we expect to get to data on that from that trial. So, you know, really seeing no basis for a difference to have opened up there. But I guess I understand the sense of unpredictability here, given the result that we have from the CRL. In terms of the Scenesse precedent, I mean, we haven't really talked about that since the end-of-phase II meeting. I think the FDA showed a lot of flexibility around endpoints here. We've seen that with other drug programs in this space. So I think it's to their credit, you know, they're clearly allowing sponsors to design endpoints that capture the appropriate biology for the drug in question, and that seems to have been applied to us as well. Thank you. Our next question comes from the line of Evan Seigerman with BMO Capital Markets. Your line is now open. Hi, guys. Thank you so much for taking my question. I actually wanted to go back to some language you used back in November 2024, around the end of phase II meeting. You noted that the FDA used... You know, you described the alignment for accelerated approval as potentially or as potential. Can you just expand kind of what led to the alignment between FDA and this medicine back in November of 2024, and might what could have potentially changed? Thank you so much. Yeah, sure. So, actually, it's pretty much the exact dataset that I shared in the earlier slide in this presentation that was available and presented to the FDA in that end-of-phase II meeting. Which, if you'll recall, we went into that meeting offering up two alternatives. You know, we provided a justification for why accelerated approval might be appropriate using protocol 49 and surrogate endpoint. We also just offered up that we would pursue a traditional approval using the APOLLO trial as a phase III trial. And the FDA, at that time, indicated interest in moving down the accelerated path, invited us to have a Type C meeting to discuss the APOLLO trial design as a confirmatory trial, which of course, is an indicator of an accelerated path. After that, we had a key meeting around the CMC package, and then a pre-NDA meeting where it was clearly asked and answered that we'd be, you know, filing an NDA, sorry, submitting an NDA on the premise of an accelerated approval. And then subsequent to that, we, you know, the NDA was accepted, granted priority review, again, on an accelerated basis. So, you know, a rich record of the FDA aligning with us on this as the appropriate path for review. But I guess, you know, the important thing to say is that they... none of that obviates the need for a review, right? And they have conducted that review and reached a different conclusion than expected, which certainly creates a lot of whiplash for everyone. I think that the general nature of NDA review is that you go from, you know, a small sub team at the FDA, focused on the package and forming an opinion about the appropriateness of the pathway that you're on and the likelihood of approval. And then you get into a broader and broader set of people in the FDA in the agency who engage and bring different perspectives and different standards. And I guess what we see here is, you know, a different standard that arose and ended up controlling the outcome. So, you know, I mean, I think that's how we see the arc of what went on here. Although, to be honest, we don't actually have a tremendous amount of information, you know, from the review process at this point. Just as a follow-up there, in your kind of, you know, interaction with the regulators following the submission and the announcement of the commissioner's priority review voucher, do you get any indication that there was skepticism around the accelerated approval pathway? Or did it seem that they were, you know, on board or just asking questions? Just trying to get a sense as to, you know, where this changed. Yeah. So this is an intense review process, a lot of information requests, you know, essentially an entire NDA review packed into a relatively short period of time, and actually, you know, a huge appreciation to the reviewers at the FDA for putting in that work, and moving along quickly. There was no obvious skepticism apparent in the information requests as we went along. And you know, I think the first indication of potential challenges may have come, frankly, from some of the leaks that we saw in the media, which was, you know, news to us, and I guess in the end, you know, spoke to the direction that things were going. All right, thanks so much, John. Appreciate it. Thank you. Our next question comes from the line of Danielle Brill with Truist Securities. Your line is now open. Hey, guys. This is Alex, on for Danielle. Thanks for the question. You mentioned previously that you've been slowing down U.S. enrollment to satisfy, you know, FDA concern about patients potentially dropping out with a commercially available fidaparin. I guess now, with the plans changing, will you have the ability to enroll a sufficient number of U.S. patients to satisfy any potential regulatory concerns for full approval? Thanks so much. Oh, yeah. I mean, we have certainly have enough U.S. patients to satisfy any kind of regulatory requirement around that. I mean, probably roughly 2/3 of the study is going to be U.S.-based. And we shifted enrollment over to Europe, which was kind of the plan anyway. Those sites in Europe come online slower, so there was kind of a natural progression of the study towards greater European enrollment. And what we've seen is just this kind of overwhelming enthusiasm and eagerness from the various European sites to get patients on to study. And so there's not going to be any need to come back and you know, reopen U.S. sites or whatnot, that we're gonna... You know, frankly, struggling to manage the enrollment demand as it is just based on the European sites that are still enrolling. Thank you. Our next question comes from the line of Douglas Tsao with HC Wainwright. Your line is now open. Hi. Good morning, and thanks for taking the question. John, I guess I'm just curious, you know, during the review process, which is obviously very compressed, did you get a sense in terms of the issue of correlation between PPIX reduction and sunlight tolerance, that they were focused on the analyses of AURORA that you presented showing that sort of temporal relationship? Or were they just sort of looking at the data, sort of, or at the study, sort of as it was initially presented, which obviously either sort of masked the underlying effect and it sort of was ultimately a very complex data set? I guess the general sense is that they were looking at everything and probing all aspects of the data, and I guess behind the scenes, forming their own opinion. John, just as a follow-up also, in terms of the commercial organization, obviously, as a company, you've been going at full speed, sort of preparing for a launch. Obviously, that's now going to likely be delayed some amount of time. Can you just talk about sort of what is going to happen with some of the infrastructure and just does that, or was the sort of spend sort of not material and not necessarily something that you're going to need to sort of keep the sales team sort of in place for the MSLs, because obviously there are other things for them to do? Thank you. Yeah, no, it's a great question. Very much where I think our heads are internally at the company is figuring out how to ensure that we continue to be capital efficient, that we do the things that we should do to ensure that when we do launch this drug, it's successful, but only do things that are clearly going to be value-creating in the long run. So that's a process we're working through, essentially reestablishing the business plan around the commercial push. And, you know, I think there'll be some greater clarity on that soon. Okay, great. Thank you very much. Thank you. Our next question comes from the line of Stephen Willey with Stifel. Your line is now open. Yeah, good morning. Thanks for taking the questions. Maybe just to build on the prior question, I guess, is there anything that you can say regarding just the pre-launch activities you're going to be prioritizing ahead of a potential approval in mid-2027, and how you might be looking to leverage this additional time to potentially improve the trajectory of initial uptake? And then I just have a follow-up. Yeah, it's a great question. And I think, you know, to give a little taste, right, I think we have had some teams out in the field, essentially using the claims database information as a call point list, right? To kind of go through each physician account that's listed in those claims data and check in to see and confirm whether there are, you know, patients actually being seen by that physician. And I think that kind of activity is unbelievably valuable for this kind of rare disease launch. I mean, I think that our ability to get the word out to patients, or to, I guess, really to physicians, who can then get the word out to patients, that's the way that we make this drug work, right? That we make... Give patients the opportunity to get it. They won't find out unless we're able to work through the physician community to get the word to them. So really, continuing the work of validating those accounts, which has progressed well, but is still in the early days relative to the 14,000 patients that are in that claims database. If we can use this time to kind of solidify that and then launch with just a crystal clear, account-validated account list for our sales team, that would be, I think, incredibly value-creating. So I think that's one activity that we would assume that we'll plan to execute on. And then other, you know, kind of related activities, that's something we'll have to think through and, you know, again, balance. You know, while I'm delighted that we are well-funded, we also wanna make sure that we're, you know, using those funds in a way that's just clearly value-creating. So figuring out the other activities we wanna engage in and how to staff those, that remains an internal question that we're working on. Okay, that's helpful. And then is there anything more you can say just about the inputs that were used to conduct the sample size or calculation within the first 50 completers? Was this a blinded assessment of either co-primary? Was it just an initial look at endpoint variability, patient dropouts, et cetera? I think just any color you can provide would be helpful. Thank you. Yeah, let me just first emphasize, it's absolutely blinded. We have no information about efficacy from that analysis. But to give a little bit more color, I'll hand it over to Will. Sure. So the analysis is, was pre-specified to look at the time in sunlight diary data and looking at the variability. That variability is, there was a, you know, an assumption that goes into a power calculation at the design of the trial, and then this analysis tests that assumption of that variability in that time in sunlight diary data. And it said that we're... the study is on track with the initial assumption of variability, so we did not have to increase the sample size from a statistical perspective. So the protocol for nine is not part of that assessment. We have high confidence in the ability to demonstrate a stat sig reduction there. That's very helpful. Thanks for taking the questions. Thank you. Our next question comes from the line of Derek Archila with Wells Fargo. Your line is now open. Hey, good morning, and thanks for taking the questions. I just wanted to know how quickly you'll be able to request that Type A Meeting, and I guess whether you'll wait for minutes before communicating the outcome. Thanks. Yeah. So I think we'll move reasonably quickly, although actually, as I mentioned before, we're really just putting together our plan right now. And yeah, we have typically wanted to get the minutes from meetings before we, you know, share anything with the public. So I assume we'll follow the same process, though, of course, it, you know, can depend on what the outcome of the meeting is. But in this case, I would assume it's something we'd wait for the minutes on, which, as you probably know, typically is about a 30-day delay. Got it. Thank you. Thank you. Our next question comes from the line of Rami Rami Katkhuda with Life Sci Capital. Your line is now open. Hi, team. Thanks for taking my questions as well. Just a couple quick ones for me. I guess first, has the FDA ever pointed to a minimum threshold of improvement in light tolerance that must be met for approval? And then secondly, can you also provide an update on the status of other NDA modules, including CMC, and whether the FDA has commented on those aspects of the application? Yeah, yeah, good question. So, no, no, threshold for light tolerance was ever identified. And, in terms of the other modules, yeah, I mean, actually we're really pleased with the way the CRL looks in that regard. You know, it's intended to be a listing of items that are causing the FDA to be unable to approve the drug, and therefore, items that we should be addressing as a company. And, you know, there's no CMC or other issues raised on that CRL. So, we interpret that as meaning that the interactions that we had around during the NDA review on those topics were satisfactory and that, you know, that they're closed off. I guess, you know, just one thing I will say about CMC, while we had reached alignment with the FDA on a drug supply that would go along with the February launch timeline, there are still some trailing PBQ activities with the commercial supply that will continue over the next few months. All indications is that those are going well and will be concluded successfully. But now that will become, you know, additional material that we'll probably at some point amend into the NDA filing. So, I guess to summarize, everything appears to be aligned, all processes agreed upon with the FDA, all CMC aspects of review complete, except that there are some final activities that we have to close out, and those, of course, will get reviewed in the final version. Got it. Thank you. Thank you. I'm currently showing no further questions at this time. I would now like to turn the call back over to John Quisel for closing remarks. Okay. Thank you, everyone. Really appreciate your time today. Again, sorry we couldn't achieve a better result. We're gonna keep working on this, and hopefully, we have great data as we come in towards the end of the year. Thanks a lot, everyone. This concludes today's conference. Thank you for your participation. You may now disconnect.