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spk03: Good morning and welcome to the IVARIC-Bio fourth quarter 2022 earnings conference call. All participants will be in listen-only mode. If you need assistance, please signal a conference specialist by pressing star then zero on your telephone keypad. After today's presentation, there will be an opportunity to ask questions. To ask a question, you may press star then one on your telephone keypad. To withdraw your question, Please press star then 2. Please note this event is being recorded. I would now like to turn the conference over to Kathy Galante, Investor Relations. Please go ahead.
spk08: Good morning and welcome to the Iverik Bio conference call. Representing Iverik Bio today are Glenn Splendorio, Chief Executive Officer, Dr. Praveen Dougal, President, Keith Westby, Chief Operating Officer, David Carroll, Chief Financial Officer, Dr. Devil Desai, Chief Development Officer, Chris Simms, Chief Commercial Officer, and Tony Gibney, Chief Business and Strategy Officer. I would like to remind you that today we will be making statements relating to Ivericbio's future expectations regarding operational, financial, and research and development matters. These statements constitute forward-looking statements for the purposes of the Safe Harbor provision under the Private Securities Litigation Reform Act of 1995. These statements cover many events and materials that are subject to various risks that could cause actual results to differ materially from those expressed or implied by any forward-looking statement. I refer you to our SEC filings, and in particular to the risk factors included in our quarterly report on Form 10Q, filed on November 4, 2022, for a detailed description of the risk factor affecting our business that could cause actual results or events to differ materially from the forward-looking statements that we make. In addition, any forward-looking statements represent our views only as of today and should not be relied upon as representing our views as of any subsequent date. While we may elect to update these forward-looking statements at some point in the future, we disclaim any obligation to do so except as required by law. I would now like to turn the call over to Glenn.
spk07: Well, thanks, Kathy, and good morning, everybody. In 2022, we continue to deliver on our goal to deliver, to provide potential treatments to patients suffering from retinal diseases with Avacyncaptiv-Pegel, or ACP, achieving a statistically significant reduction in the rate of geographic atrophy progression at the 12-month pre-specified primary endpoint across two Phase III clinical trials. We begin 2023 with the FDA's acceptance of the filing of our new drug application for ACP for the treatment of geographic atrophy, or GA, secondary to age-related macular degeneration. With the achievement of this important milestone, we move closer to our goal of providing patients with a treatment for GA, a devastating disease that leads to irreversible blindness. Additionally, our NDA has been granted priority review by the FDA and given a prescription drug user fee act or PDUFA date of August 19th, 2023. We were also informed that at the time of the FDA acceptance letter, the FDA had not identified any potential review issues and the FDA was not currently planning to hold an advisory committee meeting for ACP. This morning we announced results of a post hoc analysis on the data from the ACP Gather 1 and Gather 2 clinical trials signaling an up to 59% risk reduction in the rate of vision loss for the ACP 2 milligram groups compared to sham at 12 months of treatment. Praveen will discuss this new data in more details in a few moments. As we move closer to potential approval, our key focus in 2023 is to make ACP commercially available to physicians and their patients suffering with GA as quickly as possible. About a year ago, we started to build a world-class commercial team that includes sales leadership, reimbursement, marketing, and market access. Our commercial leadership team brings extensive experience in launching drugs for retinal diseases in large markets. We continue to accelerate our launch plans and expect to have a full U.S. team, including a field-based sales team hired by early April of this year. Our commercial team, which is led by Chris Sims, expects to have a field force of approximately 50 to 70 sales representatives and an organization of about 120 in total. Since this is our year-end call, I wanted to reflect back on some of the significant accomplishments of 2022. We received top-line data from Gather 2 in early September and finished our rolling submission of the NDA for ACP in late December. This was done in just over three months. In November 2022, we announced the FDA-granted breakthrough therapy designation for ACP for the treatment of GA secondary to AMD. To date, ACP is the first and only investigational drug to receive breakthrough therapy status for this indication, which was granted based on the 12-month results from both GATHER1 and GATHER2. We also intend to pursue further discussions with the FDA about utilizing the GATHER1 and GATHER2 clinical trial data included in the current NDA submission to support treatment of GA associated with earlier stage disease, including patients with intermediate AMD. We do not plan to conduct a new clinical trial of ACP in patients with intermediate AMD. We initiated an open-label extension study for patients who have completed their month 24 visit in the Gather 2 clinical trial with the aim of providing patients long-term access to ACP and collecting additional safety data. And we continue to invest in additional lifecycle initiatives for ACP to expand the patient population and evaluate multiple sustained delivery technologies for ACP. On the financial front, In December of 2022, we raised approximately $324.3 million in net proceeds in an underwritten public offering of our common stock. Also in 2022, we secured a term loan credit facility, providing us with up to $250 million in non-dilutive debt financing, under which we have drawn down $100 million to date. These financings further strengthen our balance sheet and provide financial flexibility as we continue to build by U.S. launch readiness plan and prepare for the potential commercialization of ACP. Dave's going to provide some more details on our cash position in a moment. I also want to acknowledge Praveen's election to the Board of Directors at the beginning of this year. Praveen has been instrumental in helping to shape the company's business strategy and in overseeing the development and regulatory strategy for ACP. Praveen, it's truly a pleasure to work with you, and I look forward to our continued work together. Before I turn the call over to Praveen, on behalf of Iveric Bio, we want to take a moment to congratulate Apellis for their approval of Cyphore, which finally provides patients with the first treatment for GA. We also want to commend the FDA for their ongoing commitment to finding treatments for patients suffering from AMD. I want to thank all of you for your continued support of Iveric Bio, and I will now turn the call over to Praveen.
spk10: Thank you, Glenn, and good morning, everyone. I could not agree more with you, Glenn. A big congratulations to our friends at Appellus. Our plans to drive ACP to a potential approval in GA has been clear and consistent throughout this journey. We believe our special protocol assessment for Gather 2, fast-track and rolling review of our NDA, breakthrough therapy designation, and now priority review further strengthens our position as we get closer to a potential near-term launch of ACP for GA patients. We look forward to collaborating with the FDA throughout the remaining NDA review process. We are excited to announce a post-hoc time-to-event analysis of the data from the Gather 1 and Gather 2 trials that signaled a reduction in the rate of vision loss for the ACP 2 milligram groups compared to sham after 12 months of treatment. In this analysis, we defined vision loss as greater than or equal to 15-letter loss in best corrected visual acuity, or BCVA, from baseline measured at any two consecutive visits. These results were consistent in the GATHER 1 and GATHER 2 clinical trials when analyzed independently. which signaled a 44% reduction with a hazard ratio of 0.56 and a 59% reduction with a hazard ratio of 0.41, respectively, in the rate of vision loss for the ACP2 milligram groups compared to sham after 12 months of treatment. In the combined analysis of GATHER1 and GATHER2 patients in the ACP2 milligram groups, experienced a 56% reduction with a hazard ratio of 0.44 in the rate of vision loss compared to sham after 12 months of treatment. This post hoc analysis evaluates the potential vision loss signal through 12 months of treatment and is an exploratory analysis in nature. On average, it takes only 2.5 years for GA lesions to start impacting central vision. It is encouraging to see vision loss reduction data at early time intervals in the first 12 months, which further supports the statistically significant Gather 1 and Gather 2 primary endpoint. This time-to-event analysis will be presented at ARVO in April. We believe this is the first time a reduction in the risk of vision loss will be presented for a potential treatment being investigated for GA. With the completion of our NDA submission in December of last year, we have been able to turn our attention to additional analyses of the GATHER program results. We believe the reduction in vision loss data we announced today is important for our planned discussions with European regulators and potential ex-US collaborators. Additionally, this timing provides us the opportunity to have the data presented at a major scientific meeting, ARVO, in April. Cross-gather one and gather two combined. The most common adverse reactions experienced by 5% or more of patients over 12 months in patients who received ACP2 milligrams was conjunctival hemorrhage, 13%. Increased IOP. 9%, most of which were transient and resolved within 30 minutes of injection, and CNV, 7%. In both GATHER1 and GATHER2, in the ACP 2 milligram groups, there were no cases of endophthalmitis, no serious intraocular inflammation events, no vasculitis, and no ischemic optic neuropathy events reported through month 12. We look forward to our PDUFA goal date of August 19, 2023. In the meantime, we will continue to work collaboratively with the FDA on review of our NDA. We believe we are well-positioned to become a leader in the development and commercialization of safe and effective treatments for retinal diseases and to create long-term value for our shareholders. We thank you for your time and support and look forward to updating you on our progress going forward. I will now turn the call over to Dave.
spk06: Thank you, Praveen, and good morning, everyone. I'd like to highlight a few items from our press release of this morning and provide some guidance on our expected cash runway. For the quarter, our net loss totaled $59.1 million, or 47 cents per share, compared to a net loss of $33 million, or $0.29 per share, per Q4 2021. For the full year, our net loss totalled $185.2 million, or $1.53 per share, compared to a net loss of $114.5 million, or $1.12 per share, for 2021. This increase in net loss was driven by increases in both R&D and G&A expenses. R&D expenses increased primarily due to the continued progress of the Gather 2 trial, increased manufacturing activities for ACP, and increases in personnel costs associated with additional R&D staffing, including share-based compensation. G&A expenses increased primarily due to increases in commercial launch preparation expenses for ACP and increases in personnel costs associated with additional staffing, including share-based compensation. Turning to our cash balance and expected cash runway. At December 31st, we had approximately $646.8 million in cash, cash equivalents, and available for sale securities. With our successful equity financing and the flexibility provided by our term loan facility with Hercules Capital and Silicon Valley Bank, we believe we have the financial resources required to launch ACP for GA in the U.S., if approved, and to meet our planned capital expenditures, debt service obligations, and operating expenses for at least the next 12 months. This estimate does not include any potential new borrowings under our term loan facility beyond the $25 million that we plan to borrow in 2023, based on the FDA's acceptance for filing of our NDA. Upon the FDA's approval of ACP, we may borrow an additional $75 million from our term loan facility. Thank you for your time, and I'll turn the call back over to Glenn.
spk07: Well, thank you, Dave, and thank you, Praveen. Operator Andrew, if you can open the line for questions, please.
spk03: Yes, sir. We will now begin the question and answer session. To ask a question, you may press star then 1 on your telephone keypad. If you're using a speakerphone, please pick up your handset before pressing the keys. If at any time your question has been addressed and you would like to withdraw your question, please press star then 2. At this time, we will pause momentarily to assemble our roster? The first question comes from Annabel Cimini with Stifel. Please go ahead.
spk09: Hi, everyone. Thanks for taking my questions and congratulations on the progress. It's getting to be really exciting and heated. So, the vision loss benefit, I guess is really interesting. I guess the way it's been phrased is that nobody really expected it this early on. So should we view this as a possible functional benefit that you can put in a label? Will they put post hoc data or exploratory endpoints in a label? Is this something that you can use to sort of, I guess, present yourself competitively to the market? And is there any more tangible functional measurement than that? Is this like the ultimate functional benefit that you can measure here?
spk10: Anabel, this is Praveen. Good morning and thank you for your question. In regards to our labeling discussions, look, we are under review currently by the FDA and we obviously don't want to be talking about our discussions with the FDA. I really have no comment on that whatsoever. The message that I think this post hoc analysis gives us, and again, I want to emphasize that this is a post hoc analysis of a pre-specified safety endpoint. And we should look upon this as exploratory data. However, having said that, we also believe that it's quite impactful. The message here really is that vision matters and time matters. And let me take each one of them separately. The regulatory agencies have said that ultimately function will follow anatomy. And we've looked at an endpoint that involves a slope analysis. And I think what we've been able to show here with this post-hoc analysis is that that loop may be closed. This is the first time that we've really demonstrated a vision delta, a vision benefit, based on the anatomy. So function did actually follow anatomy. In terms of time, time does matter. This is not like treating a wet AMD, for instance. In wet AMD, you can have fluid there. The fluid may be resolved with anti-VEGF usage, and function may come back. Here, once the photoreceptor cells die, they don't come back. So the time of onset really does matter. We were very pleased to see that the time of onset was early in this retrospective analysis. So I think At the end of the day, this we consider supportive of our primary endpoint, which is the slope analysis. This is supportive data of the primary endpoint. And again, I think the message here is that vision matters and time matters. And yes, there will be data coming out that will be additive to this, and we will be talking about this in major meetings, and you will see other supportive data coming out as well. Thank you for your question.
spk09: And if I can ask one more question, you know, a lot of people are talking about target populations, who's the low-hanging fruit. And I think you've even stated in the past, bilateral patients who've lost vision in one eye and have risk of loss in another eye, as well as possibly patients with GA in one eye and wet AMD in another, because they're already in the practices. I guess I'm curious about the latter target population. You had not studied patients with wet AMD in the other eye. I just want to make sure I understand it correctly. You had excluded patients with wet AMD in the other eye, I think. you know, just to reduce the risk of conversion. So how do we square that with the target populations that we might go after? Or maybe I just didn't understand it correctly. Maybe you can clarify. Thanks.
spk10: Yeah, to be very clear, the reason that we excluded patients with a corneovascular membrane in the fallow eye is really quite simple. It's because if we want to ensure that there is no crossover effect, these patients would effectively have to come in for up to two years every other week to be injected in one eye at a time. And we felt that that was an excessive burden to be placed on these patients in clinical trials. And that's why those patients were excluded. That was the only reason, no other. In terms of the target patient population, I don't think the fellow eye exclusion has any bearing on the target population whatsoever. I think what clinicians are looking for is an effective, efficacious, and safe treatment. And I believe that, you know, as a clinician, I think all of my patients with geographic atrophy and also with severe intermediate macular degeneration are patients that I would consider for treatment. So I think, again, what we provided here today, the postdoc analysis, is a basis for that conversation, which is that there is potential here. Again, this is an exploratory retrospective analysis, but there's potential here to prevent catastrophic vision loss, and I think that is quite impactful.
spk09: Okay, great. Thank you so much.
spk03: The next question comes from Ken Cacciatore with D.D. Cowan. Please go ahead.
spk02: Hey, team. Congratulations on all the progress. I'm wondering if maybe you just step back and take a little bit of a crack at talking about the market itself, the size, and maybe how we should be thinking about the evolution of it. And then, Praveen, you get to be – you're someone who's – sat in front of real patients with this real issue. Can you just talk about their motivation to treat? I know there's a lot of discussion about the frequency of treatment, but would really like to get your perspective on it. And then maybe within that, how the real world use on dosing may play out. And then just lastly, you keep on highlighting intermediate, and it makes a lot of sense. Can you just talk about what the implications of that would be on utilization and how would it differentiate the label if you were able to get it? Thanks so much.
spk10: Ken, thank you, and good morning. Thank you for your questions. Let me first ask Chris Sims, who is our chief commercial officer, to answer the first part of the question that you asked, and I'll handle the rest. Chris?
spk00: Yep. Hey, Praveen. Hi, Ken. Thanks for the question. I think the first part of your question is related to market size, and I think you'll share what we've shared previously. We believe it's a significant market. You know, as we've said publicly, best measures is that, you know, we believe there's about a million and a half to two million patients in the U.S. alone that have some level or some stage of geographic atrophy. We also believe that number could be undiagnosed based on the sources of those data and the fact that some of that data is from a number of years back. And one of the things that we believe is important for this market is the education, notably upstream, where we believe a lot of these patients are not sitting with retina practices today. We believe the majority are under the care of an upstream ophthalmologist or an optometrist. So therefore, the need, I think, to educate and engage with that community is critical to help facilitate awareness and ultimately diagnosis and referral for treatment. So our modeling on the market has not changed. We still believe it's quite a significant market. However, the need for that education remains pretty high. I hope that helps.
spk10: Thank you, Chris. The other questions, Ken. So the conversations with the patient and what this means to me as a clinician, this retrospective data. And as I mentioned to Annabelle, this allows me a language that I can have with the patient, which is to say, when you have a loss of vision of 15 letters or more, that truly changes a patient's life. That is catastrophic. And to be able to decrease the risk of that is really quite meaningful. So that allows me an avenue to have a very direct and very transparent conversation with the patient. And the other question might be, well, what kind of patient? And I know there's been a lot of discussion regarding central involving or non-central involving patient. And I just want to clarify that as a clinician. Look, I believe all patients with geographic atrophy, center-involving and non-center-involving, early and advanced, all of these patients are eligible. A patient who has center-involving geographic atrophy may not progress as quickly as a patient that doesn't have center-involving geographic atrophy. However, a lot of these patients, when I was in practice, would come in, their head may be a little bit tilted, They would be looking from an island of paraphobial photoreceptor cells that they've preserved, and that's what would allow them from tripping over furniture and burning their hands on stoves and et cetera. So this drug will be very valuable for those patients. I would argue that those patients would benefit directly from this drug. Now, would I enroll a patient like that in a clinical trial? Probably less likely because it's less measurable, the delta would be. But that doesn't mean that the patient wouldn't have a great deal of benefit from this drug. So the bottom line to my answer is that yes, I think all patients, regardless of how big the geographic atrophy is and where it is, unless of course it's completely burnt out, would be eligible for a safe and efficacious drug. In terms of dosing, look, you know that we will have every other month data in our second half of the year. and of the second half of the study, of course, and our first year card turn was on September 7th, so you can do the mathematics there. However, dosing is, in my opinion, is really not going, dosing frequency is not going to be determined by what's in the label. It's really going to be determined by what the patient can do. The conversation is going to go something like this. I'd say, Mrs. Smith, we have a drug. that will help you and reduce your chance of having catastrophic vision loss potentially. And to get the best results, you would come in every month, as close to every month as you can. And Mr. or Mrs. Smith would then come in as close to every month as he or she can. And that will determine the frequency of treatment, not necessarily what's written in a label. As far as your question on intermediate macular degeneration goes, Look, there's a very broad range here. Intermediate macular degeneration can be anywhere from one drusilla to severe intermediate macular degeneration where patients have metamorphopsia, changes in color, contrast sensitivity, et cetera, with large drusilla and serous fluid. We have said publicly that we will not be doing an intermediate macular degeneration study in order to target this patient population, and we believe that having a safe and efficacious drug, as we believe ACP has the potential to be, will allow us to target that patient population as well. Thank you for your question, Kim.
spk03: The next question comes from Ellie Merle with UBS. Please go ahead.
spk05: Hey guys, thanks so much for taking the question and exciting data on vision loss. Maybe can you just comment a little bit in terms of the vision loss definition of 15 letters or greater and I guess why 15 and whether you looked at other thresholds as well? Thanks.
spk10: Ellie, good morning and thank you for your question. The 15 letter milestone or landmark is really traditionally accepted as one that is a devastating amount of vision loss or a significant amount of vision gain. And that's the doubling of the vision angle. And that's traditionally accepted by regulatory agencies as an important landmark. That's the reason that we chose to show that and do the analysis in this particular press release. Now, having said that, yes, we've done sensitivity analyses on several other landmarks as well. And we're convinced, because of the sensitivity analysis that we've done exhaustively, that this trend is a real trend. Again, I want to emphasize that this is a pre-specified safety endpoint. It is a post-hoc analysis. But, yes, we've done numerous and exhaustive sensitivity analyses on this and are convinced that this trend is real and that it is impactful.
spk05: Great, thanks. And maybe just in terms of those sensitivity analyses, is that data that we'll see at the presentation? And just if you can comment if there were any subgroups where you saw perhaps an even greater effect. Thanks.
spk10: Yeah, Ellie, we have not yet put together that presentation as yet, so I can't comment on that. We will certainly be showing the data that we've released today. And what I can tell you is that we are doing extensive studies based on providing you additional information regarding this functional benefit or potential functional benefit, which will be presented in other major meetings as well. Thank you for your question.
spk03: The next question comes from Mike Oltz with Morgan Stanley. Please go ahead.
spk04: Good morning. Congratulations on all the progress as well, and thanks for taking the question. Maybe just to follow up on the promising vision loss data you provided this morning, just curious if you're considering maybe exploring that further in maybe a prospective lead design study.
spk10: Thanks. Mike, good morning. And again, thank you for your question. What we've shown today is a post-hoc retrospective study. And we believe that this is very impactful, very important data that supports the primary endpoint. That's the reason we presented this. We also believe that it forms a basis for doing future studies that may well be prospective and randomized. You know, certainly these are things that we can add on to. with future studies, and all prospective randomized studies are really based on data that you get from encouraging retrospective analyses, so it certainly forms a path and a basis for future studies. Having said that, however, remember our expectation and our goal per our agreements that we've outlined with the regulatory agencies our submission and potential acceptance of our NDA filing based on the 12-month primary endpoint, and that hasn't changed. I just want to make sure that we don't confuse those two things. Our expectation is that the NDA will be reviewed based on our pre-specified agreements that we've had with the FDA, based on the SPA, based on the breakthrough designation, and based on the primary endpoint, which is that month 12. Thank you for your question.
spk03: The next question comes from Greg Harrison with Bank of America. Please go ahead.
spk12: Hey, good morning, and thanks for taking the question. Are there any thoughts that you can share with us on the breadth of the Appellus label? And without going into your discussion, maybe just if there's any implications that, you know, for your label, as a result of what we've seen with them.
spk10: Greg, good morning and thank you for your question again. It really would be inappropriate for any of us to comment about APALIS other than to say what, and after this maybe Glenn wants to say a few words as well, other than to say we are very happy that patients are getting a treatment. It's long overdue, and Apellis and the entire team deserves a great deal of credit for coming across the line here in terms of having a medicine that will help patients. We look forward to seeing how their launch is. We wish them very, very well, but it really would not be appropriate for us to comment on a competitor's label. Maybe I can pass it to Glenn and see if Glenn has a few words to say as well.
spk07: Yeah, Greg, and thank you for the question, and I go back to what we just said in the script. I congratulate them. It's really exciting to see a company finally be able to have a drug that patients could use, and I think that's just outstanding. As Praveen said, we wish them luck. You know, we will learn a lot from them, and, you know, we're just thrilled at patients, and we're thrilled that patients have a drug available to them, and we're thrilled for Pellis.
spk12: Okay, great. And then as you're in the review process here and preparing for U.S. commercialization, where are you at in the process of potentially finding an ex-U.S. commercialization partner, and what are you looking for in such a partner?
spk07: Yeah, sure, thanks. And thanks for the question, Greg. I think with today's data, we continue to build on the data set. And I think all of this is very important into finding a future partner. You know, as we said in the past, we do have a number of meetings in the first half of the year with European regulators, which will give us more guidance. Having data like we presented today, we believe may be helpful in those discussions. So that all continues to move forward. Our objective, as we have said in the past, is to focus on the U.S. market and to find help overseas. Today is just another point of reference or data that will be helpful in that XUS discussion. So that all continues and we'll keep you posted on our ongoing discussions with European regulators.
spk03: Great, thanks again for taking the question. The next question comes from Eddie Hickman with Guggenheim Securities. Please go ahead.
spk01: Hi, good morning and congrats on the progress. Just a few from me. Throughout Gather 2, you were able to provide updates on the injection fidelity, which gave you confidence on meeting that primary endpoint. Are you able to give any color on how that's tracking so far in the second year?
spk10: Eddie, good morning, and thanks for your question again. What I can tell you is, as of now, we haven't guided the numbers as yet, but I can tell you that we're very, very pleased with the way that that's tracking. We've got a fantastic clinical operations team, and they're very, very hard at work to make sure that all these patients are retained and that the injection fidelity is as high as possible. So we haven't given guidance as to the numbers as yet, but I can tell you that we're doing very well and are very pleased with the ongoing process.
spk01: Great. And then really interesting visual acuity data that you presented. I'm curious if that's something you can share with the FDA as part of your back and forth that you get with your breakthrough designation without needing to file any additional amendments, just to sort of show them the confidence that you're seeing on that functional endpoint throughout the early part of the review. Thanks.
spk10: Yeah, Eddie, as you know, we're under review at this time. We've said publicly that we're very pleased with our interactions with the FDA. We found them, as expected, to be extraordinarily collaborative And we feel that the questions that are going back and forth are exactly the right questions that we would like and that we are doing, we believe, everything the way that the FDA would like us to. So we're very, very happy with the interactions. But other than that, we certainly don't want to be publicly commenting on any details regarding the discussions that we're having with the FDA. But thank you for your question.
spk03: The next question comes from Kambiz Yazdi with Jefferies. Please go ahead.
spk11: Morning, team. Can you provide us any more color on your interactions with the FDA on intermediate AMD? And then we have a few more follow-ups after that.
spk10: Kambiz, good morning and thanks for the question. What we've said publicly is that with the interactions that we've had, we will not be doing an intermediate AMD study. As we've announced, I think, some time ago, we feel that we'll be able to target intermediate AMD without doing a specific study for intermediate AMD because this is considered a continuum of disease. We've said that publicly, and other than that, we have not guided as to any further details regarding our interactions with the FDA. Okay.
spk11: Excellent. Thank you. And then if ACP is approved in August, what would be the general timeframe for receiving a permanent J code for ACP?
spk10: Chris, maybe I can pass that question on to you.
spk00: Yeah. Thanks, Praveen. And thanks for the question. So following our August PDUFA date, it's an important question, by the way. So we plan to file at the first quarterly opportunity, which, again, based on the August PDUFA date would be the 2nd of October would be the first opportunity to file for the permanent J code. And then following that timeline, we would expect to get the permanent and hope to get the permanent J code in the early second quarter of 24.
spk11: And one final one, just to put a final point on every other month dosing. If the data are positive from year two of Gather 2, would you pursue every other month dosing for ACP? Would this have to come as a SMDA? Appreciate all the answers today. Thank you.
spk10: Yeah, Kambis, we have not guided us to that. We obviously want to see the data. We want to see what the situation is like at that time. That's a decision to be made down the road. But We really don't believe that having every other month dosing really provides any kind of a competitive advantage because we believe that physicians will treat according to what's best for the patient. And what's best for the patient is going to be dependent also on how often the patient can come in. And that's going to be the primary determinant of the frequency of treatment, not what's written in the label. And just to kind of put an emphasis on this, if you look at the anti-VEGF experience, for instance, the vast majority of us treat and extend, and that's not in any label. So there is a history of my colleagues, you know, really doing what's right for the patient given the particular situation, regardless of what the label says. So the answer to your question is, look, I'm not really sure what we will do with the 24-month data, whether it be on the label or not, that's yet to be determined. Thank you so much.
spk03: this concludes our question and answer session I would like to turn the conference back over to Glenn Splendorio for any closing remarks.
spk07: Thank you Andrew and thanks everyone for listening this morning and we're very happy and pleased with our progress and we look forward to our continued work with the FDA and our NDA filing and hopefully a potential approval in late August of this year. We're also committed, as we talked about today, to building a world-class commercial team to be ready to engage physicians, healthcare providers, and patients if ACP is approved. And finally, we look forward to having our vision loss data presented at ARVO. So you can expect continued execution from us. We always enjoy speaking to all of you, and have a great day. Bye-bye.
spk03: The conference has now concluded. Thank you for attending today's presentation. You may now disconnect.
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