Welcome everyone to The 41st Annual JPMorgan Healthcare Conference. My name is Tessa Romero. I'm one of the Biotech Analysts here at JPMorgan. I'm joined by Taylor Hanley and Adhiraj Chauhan from the team. Our next presenting company is Acadia, and speaking on behalf of the company, we have CEO Steve Davis. Before I turn it over to Steve, I just wanted to highlight that we do have a Q&A session after this formal presentation. There's an Ask a Question button in the portal for those that would like to submit in a question, or we will have mic runners to take live questions as well. With that, I'm gonna hand it over to Steve. Great. Thanks so much, Tessa, and thanks to each of you for weathering the conditions getting over here. We had a little respite in the rain, hopefully you all made it over dry this morning. Thanks to each of you who are joining remotely. I need to start with the obligatory forward-looking statement. The business of drug commercialization and development has a number of inherent risks. Please see our SEC filings for a description of those risks as they relate to our business. I'd like to start this morning with why we do what we do. What you see here are families of Rett syndrome patients and Parkinson’s Disease Psychosis patients. They're very significant and debilitating disorders in both cases. Our mission is to elevate life and to restore some of the constraints or the loss that they have due to the constraints of their disease. This morning, I'd like to start by recognizing the people that deserve our very best, and that is the patients that we serve. There are four strategic priorities that underlie our business. First is our franchise with NUPLAZID and Parkinson’s Disease Psychosis. We've guided to 2022 revenues of $510 million-$520 million. We'll be announcing those revenues relatively shortly when we release fourth quarter earnings. That franchise has been cash flow positive and profitable since 2019. It's an important foundation for our company. What NUPLAZID represents is the first and only drug approved to treat Parkinson’s Disease Psychosis. I'll go into greater detail in that in a few minutes. Our second priority is preparing for the launch of our second drug, trofinetide for Rett syndrome. We completed a successful phase III program and have filed a new drug application with the FDA. Our PDUFA date is March 12th this year. It's coming up very shortly. Here too, trofinetide represents, if we're successful, the first approved drugs to specifically to treat the core symptoms of Rett syndrome. Third priority is negative symptoms of schizophrenia. We have completed a positive pivotal study, our ADVANCE-1 study in this disorder. We have a second pivotal study ongoing, our ADVANCE-2 study. We should complete enrollment in the ADVANCE-2 study around the middle of this year. It's a six-month treatment period, we should have results in a little over a year from now. The fourth priority on this slide is Alzheimer’s Disease Psychosis, where we're continuing to invest in a very significant unmet need. Both in Parkinson’s Disease Psychosis prior to the approval of NUPLAZID and in Alzheimer’s Disease Psychosis today, all of the antipsychotics on the market are not indicated for use. They're not approved for use in these disorders. NUPLAZID is the only antipsychotic approved to treat Parkinson’s Disease Psychosis, and we're continuing to invest significantly in trying to provide relief for the patients with Alzheimer’s Disease Psychosis. Our lead candidate here is ACP-204. We're nearing the end of phase I work. We should complete that work around the middle of this year, and then we'll move quickly into studies in Alzheimer’s Disease Psychosis patients. Just one final footnote before I go to the next slide. We have a very strong balance sheet. We are approaching cash flow positivity. We do not need to go back to the capital markets to raise additional capital with the one caveat, of course, being if we do significant business development above and beyond what we've done historically, then that would be a very good reason to do it. We're in a very good position in a very turbulent capital market today. This slide represents our broader portfolio in addition to the four priority programs I mentioned a second ago. We have an important and burgeoning early portfolio, both disclosed and undisclosed programs, highlighted by our SYNGAP1 program. We have a second Rett syndrome program, at an early stage and a number of other programs that we're continuing to pursue, and we're very excited about not only the later stage programs that I'll go into greater detail today, but also our early stage portfolio. I'm gonna shift now to focus on NUPLAZID and Parkinson’s Disease Psychosis. I mentioned that we'll achieve over $500 million in annual sales in 2022. I noted that NUPLAZID has been cash flow positive in addition, increasingly profitable since 2019. This population has been significantly impacted by the pandemic. Parkinson's disease patients obviously have very compromised medical condition. They're elderly patients. Parkinson’s Disease Psychosis typically occurs in the last four to five years of life of these patients. We've lost a lot of these patients in the early days of the pandemic. The market is just simply smaller. The population is smaller. A lot of these patients died. We've continued to gain market share in a smaller market. The two principal headwinds that's impacted our business, and maybe more importantly, the medical care of these patients are in the office-based setting, we're continuing to see, it's been very persistent throughout the course of the pandemic, patients seeing their physicians in person about 80%-- 75%-80% of the rate at which they saw their physician in person prior to the pandemic. When physicians are not seeing their patients in person in this population and for this condition, they're very reticent to prescribe new drugs. It's impacted our new patient starts in the office-based setting. In the long-term care setting, which is about 25% of our business, the office-based setting is about 75%. In long-term care, the headwinds have manifested primarily in addition to just the loss of population due to mortality during the pandemic. There have been significant staffing shortages. We've seen reductions in occupancy rates, reductions in new admissions, et cetera. We're beginning to see that change. In the long-term care setting, we're beginning to see those conditions improve, and we are beginning to see some growth in that portion of our business. We're not seeing those changes yet in the office-based setting. If you sum all of that up, what we're projecting and expecting to see is steady volume in this disorder and in this and in our business with two catalysts that could change that. One is just a change and improvement in the pandemic conditions. I don't think this will last forever. I don't think this is a frame shift and patients will just behave differently and doctors behave differently in the longer run. Today, the conditions continue to impact our business and most importantly, continue to impact the medical care of these patients. That's one thing that can catalyze growth. The second is, and I'll go into greater detail in the next slide, but there are three very important new papers that have been published just in the last six months that highlight the benefits of pimavanserin relative to atypical antipsychotics that are, although they're not approved for use in Parkinson’s Disease Psychosis patients, they're many times used off-label. I'll get to that more in a minute. Sometimes we get questions around the Inflation Reduction Act and the impact on our business. I can sum it up really quickly. It'll have a very modest impact on our business for the remainder of this decade. We'll see a net pricing benefit of approximately 3%, + 3% in through the third quarter of 2023. Sorry, skip this slide. I'll finish this up really quickly. We'll get some short-term benefits due to being qualifying for small business treatment under the act. We do not expect to be subject to Medicare pricing negotiation at least through the remainder of this decade. Let's go to the real-world evidence that I referred to earlier. Three papers, two of them assessing is there a difference in mortality rates between, in one case, Parkinson's patients and in the other case, Parkinson’s Disease Psychosis patients that are treated with NUPLAZID vs atypical antipsychotics. What we see in the upper left-hand corner here is in the first publication came out just about six months ago, a paper by Mosholder et al. They demonstrated in this real-world evidence study. What I mean by that is they took the Medicare claims database. It's a massive database, and they probed it to look at patients treated with NUPLAZID vs atypical antipsychotics. You have all sorts of great information that comes from that in terms of hospitalization rates, mortality rates, long-term care admissions, et cetera. What they saw here was a 23% lower mortality risk for NUPLAZID vs atypical antipsychotics. At doing just the first six months, it was 35% lower mortality risk. That benefit was maintained all the way out to 360 days. That statistically significant difference in mortality between patients treated with NUPLAZID vs those on atypical antipsychotics. Second paper by Layton et al, just published a little over a month ago. Almost identical results. 22% lower mortality risk for patients taking NUPLAZID vs those taking atypical antipsychotics. Hazard ratio of 0.78. First 180 days of treatment, 34% lower mortality risk. Cumulative mortality at one year, 23% lower on NUPLAZID than atypical antipsychotics. I should, just for context, note that all antipsychotics have warnings in their label that say there's an association of higher risk of mortality in elderly demented patients that take these drugs vs those who don't. Our label and the warnings go further to say this drug is not approved for treatment of those patients. Our drug, NUPLAZID, is the only drug that has a carve-out that says in the second statement, "This drug's not approved to treat these patients unless they have psychosis associated with Parkinson's disease." This is very important information from a medical perspective. We're in the process of disseminating this information, making sure that we do our job to get it out into the medical community, and we're very eager to see it absorbed in the community. Third paper deals with healthcare utilization. Again, probing the Medicare claims database to assess patients treated with NUPLAZID vs atypical antipsychotics. Is there a difference in hospitalization rates, in ER visits, in the length of hospital stays, et cetera? What we see here, again, is statistically significant lower All-cause hospitalizations, ER visits, length of stay in hospitals for NUPLAZID vs atypical antipsychotics. This is obviously very important information from a medical perspective in terms of loved ones that are in long-term care facilities. It's also important from a business perspective to these long-term care facilities because these rates of hospitalizations, ER visits, length of hospital stays, et cetera, all feed into their star ratings. If you have a family member or loved one that is in a long-term care facility, you're probably familiar with this. I do, and I remember when my parents went into long-term care, us looking at the star ratings of various institutions to kinda get a sense, "Well, how is the medical care at this facility different from that one?" It has a real economic impact to the business of these facilities. Having the potential benefit of NUPLAZID, having lower causing lower rates of these feed into their star rating is something that every long-term care facility is very focused on. Again, three important papers that have come out just in the last six months. We're in the process of getting them into the hands of the medical community and helping them digest the information. I'm gonna shift gears to trofinetide for Rett syndrome. I need to start by saying this is a extraordinarily debilitating disorder. It affects mostly girls. The males typically die in utero. There are a few male patients, but it's mostly girls. They develop normally for about the first two years of life. Then at about age two, where they typically can walk and talk, they begin to deteriorate developmentally, and they reach a point where they can't walk or talk, typically. Almost all these patients are in wheelchairs their whole life. They usually lose the ability to communicate verbally and many times non-verbally as well. It's a very, very heavy burden on the girls, of course, but also their entire families. They have other symptoms besides the developmental symptoms relating to many times they have seizures, many times they have respiratory issues. For those kinds of non-core symptoms, there are drugs to treat those symptoms. We have anti-seizure medications. We have drugs that benefit respiratory activity. There is no drug approved to treat the neurodevelopmental, the core symptoms of this disorder. There are about 69,000 Rett patients in the United States, so it's a rare disease. There are approximately 4,500 patients that have been diagnosed and are being treated today. Again, not treated for the core symptoms 'cause there's nothing to treat it, but treated for the other symptoms that they have. I'm sorry, just one other footnote in terms of this being a neurodevelopmental disorder. That's important because if it were a neurodegenerative disorder, if the neurons were actually dying, then and many neuro, particularly rare neuro diseases do have that characteristic, then you would have to catch the patients very early in order to... Once the neurons are died, they're gone. The neurons are still alive in these patients. They've just lost the ability to communicate or the ability to communicate across the synapse. That space between neurons has been significantly degraded, leading to a whole array of symptoms across all of their developmental capabilities. Trofinetide is thought to work. Many times we don't know exactly how drugs work. Even a lot of the very common drugs that we all take and are familiar with, we don't know exactly how they work. It's thought to work by increasing the synaptic communication and by also being a neural anti-inflammatory, having a neural anti-inflammatory effect. When we tested this drug in phase III, we were eager to see, does it have a positive benefit? It had a benefit in phase II studies. We're also eager to see, well, what kind of benefit does it have? What we see on the left-hand side here in the Rett Syndrome Behavioral Questionnaire is statistically significant benefit on trofinetide with a two-sided p-value of 0.0175 and an effect size of 0.37. Importantly, there are eight domains in the Rett Syndrome Behavioral Questionnaire. Again, they relate to the broad array of symptoms that these patients have. We saw positive movement across all eight domains. That lines up with what we believe about the way the drug works. We believe, we know that Rett syndrome patients have a loss of synaptic communication throughout their brain. And we believe that trofinetide increases that synaptic communication and that then should produce benefits across the array of symptoms, and what we saw in this study is indicates that it does. In this study, we did something that is not terribly uncommon, but it's always a higher challenge when you are developing a drug. We have 2 co-primary endpoints. What that means is in order to have a successful study, you have to have statistically significant results across on both endpoints. Here the R-Rett Syndrome Behaviour Questionnaire is a caregiver assessment. On the right-hand side here, you see an investigator assessment, the Clinical Global Impression of Improvement Scale. Here, too, we see statistically significant results, two-sided p-value of 0.0030 and an effect size of 0.47. Very unequivocal efficacious benefits of the drug. Our key secondary endpoint is a scale that primarily is measuring communication ability, and we also saw statistically significant results there with a strong effect size. On the basis of these results, we filed a new drug application with the FDA. Our PDUFA date, as I mentioned earlier, is March 12. We're eager to get to the PDUFA date. From all of the communication we have with FDA, everything appears to be on track, and we're looking forward to getting there. I mentioned earlier that we're making significant investments in preparing for this successful launch in Rett syndrome. I can sum these up in really three buckets. First is driving disease state awareness and education. Obviously, if you're a physician that's treating a Rett patient, you know what Rett syndrome is. If you're parents of a Rett syndrome patient, you know what it is. Because of the broad array of symptoms, sometimes physicians and caregivers are not tuned into all of the various elements of the disease. An important part of the foundation we're laying now in the disease education work we're doing, and will continue to invest heavily in post-launch, is fine-tuning the awareness of these symptoms so that physicians and patients are better, excuse me, and caregivers are better equipped to recognize benefits of the drug. That's an important element of what we're doing on both the efficacy side as well as tolerability. We're doing some very important work laying the foundation there. It's always important prior to launch of a drug, but particularly in a rare disease where patients have a broad array of symptoms, it's a very, very important exercise for us. Second is we've hired a very seasoned leadership team with significant experience in rare disease. I mentioned earlier, there are about 4,500 Rett patients diagnosed in the U.S. Many times, when you launch a new rare disease drug, the first order of business is can you find the patients? 'Cause it's rare. Patients don't pop up with every neurologist. In this case, we have the benefit of having a patient advocacy org, two patient advocacy organizations that are very, very active and have done a excellent job of identifying patients. In one case, their membership list runs into the 1,000 s of patients. I think we'll have the benefit of having a relatively identifiable population right from the beginning. These Rett patients tend to be treated in three different settings. About a quarter of the patients are treated in centers of excellence. There are currently 22 centers of excellence. There are a couple more that are in the process of being designated by the patient advocacy organization that designates them. About a quarter of the patients are treated there. A significant majority of the patients are treated at other hospital settings that are not designated as a center of excellence, but typically run academic centers, et cetera. A small group of patients are treated at standalone neurologist offices that are not associated with a hospital. Our launch plan includes plans to tackle all of these in an appropriate manner. I think the take-home message here is that while this will be a separate sleeve, a separate dedicated sales force that we will have, We don't need a vast footprint to cover this territory. It's fairly concentrated. Third point is continue to leverage the strong support that we have in the Rett community. We're doing all the things you would expect us to be doing. We've established a hub. We have extensive resources that are will be coming to bear to provide patients, caregivers, healthcare professionals with extensive support in transitioning from a disease that has no drug to treat it to one that does. Everything that I've described on this slide is stood up, ready to go. We're eager to get to March 12th. I'm gonna move to negative symptoms of schizophrenia. Here, we're exploring with pimavanserin, that's the generic name for NUPLAZID. The utility of pimavanserin in treating the negative symptoms of schizophrenia. Let me just start with a little bit of context here. The negative symptoms, when we think about schizophrenia, many times we think in terms of hallucinations, delusions, paranoia. Those are all characterized as the positive symptoms of schizophrenia. For the last few decades, when I got into this business a few decades ago, our... One of the first things I did was do a collaboration between my company and a large pharmaceutical company with a drug that we hoped would help treat the negative symptoms of schizophrenia. I remember at that point in time talking to KOLs, and they said, "The most significant unmet need we have today is negative symptoms." Those are the symptoms that are, that manifest into social withdrawal aspects of the disorder that lead to low social functioning, long-term disability, and very significant caregiver burden. Today, 29 years later, we've not moved an inch on negative symptoms of schizophrenia. There's still no drug approved to treat those symptoms. Drugs that treat the positive symptoms sometimes many times have an indirect benefit on negative symptoms, but it still leaves almost half of the patients of schizophrenia patients, with predominant negative symptoms that are untreated with no drug approved. Our approach here with pimavanserin led us to run a pivotal study, we call our ADVANCE-1 study, in negative symptoms of schizophrenia. What we achieved here is something that's been rarely seen in negative symptoms. We have a positive pivotal study. As you can see here, we had about a little bit of dosing flexibility here 'cause we wanted to explore dose range. What we see here is when we look at all three doses tested, we have a statistically significant positive result, p-value of 0.043. Importantly, though, at the tie dose, the 34 mg dose, that's the same dose that we're approved to treat Parkinson’s Disease Psychosis patients. We saw a significantly stronger effect in that group, p-value of 0.0065. Again, something rarely seen, negative symptoms of schizophrenia. We're very excited about these results. On the basis of these results, we are now nearing the completion of enrollment in a second pivotal study, our ADVANCE-2 study. There are two key differences between ADVANCE-1 and ADVANCE-2, both of which are designed to increase the probability of success. One is I mentioned that we allowed for some dose-ranging work in ADVANCE-1, but with much stronger results when we look just at the 34 mg dose. In ADVANCE-2, we're only studying the 34 mg dose. Again, that's the dose we're approved in PDP. It was clearly the most efficacious dose here. The fact that we won't have other doses at patients on lower doses that have a diluted, dilutive effect should benefit the probability of success in this study. The second is it's well established, FDA has even commented on this publicly that it's over the last four decades, it's become increasingly difficult to show to separate from placebo in schizophrenia studies conducted in the United States. It's very well known. If you follow other companies developing antipsychotics, I'm sure you've heard about this. I don't have time to get into why that's the case, but it is the case, and it primarily is a result of the way we treat schizophrenia in the United States vs the way it's treated in Europe and other parts of the world. In ADVANCE-1, we studied enough patients in the United States. We don't need to study more. ADVANCE-2 is being conducted entirely outside the United States, and that typically makes it easier to differentiate vs placebo. Again, we should include enrollment around the middle of this year and with results a little over a year from now. I'm gonna move now to our earlier portfolio. Most importantly, I'm gonna start with ACP-204. With pimavanserin, we have a very successful drug with a robust antipsychotic effect and a very positive safety profile and tolerability profile. We're taking those learnings, and we've applied them to several other molecules, the most advanced of which is ACP-204. We have some others in the pipeline as well. We're gonna focus on ACP-204 for now. Again, we're leveraging the learnings we have, both pimavanserin or NUPLAZID and ACP-204, work primarily by blocking 5-HT2A. That conveys certain benefits and this very favorable tolerability and safety profile. With pimavanserin, we do have a little bit of baggage, and it primarily relates to a modest QT signal. If this were a drug to treat schizophrenia patients, it would pretty much be a non-issue. Those drugs are prescribed by a psychiatrist. They're very comfortable with polypharmacy. A majority of those drugs have QT elongation signals. They're very comfortable with that. They dose those drugs on top of other drugs that have the signal, and it's not a concern to them. When you get to elderly, medically compromised patients in Parkinson's disease or in this case, Alzheimer’s Disease Psychosis, a very different situation. They're dosed many more times by neurologists who aren't as comfortable with polypharmacy and just given the medical condition of these patients, they're more focused on things like QT elongation. One key design element of ACP-204 is to minimize or potentially eliminate the QT signal. Based upon the phase I data we have to date, it appears that we've done that. Again, more to come on this, but all the data we have so far is lining up with the design elements that we put into the molecule. There are other elements of the molecule that may lead to increased efficacy. There's actually an indirect benefit to minimizing the QT signal here. In addition to it just making it easier for physicians to prescribe and think about and think about, you know, co-administering it with other drugs that may have a QT signal elongation. We just couldn't go any higher on the dose with NUPLAZID. 34 mg is as high as we could go based upon the QT signal that we saw. There may be more that we can get out of this mechanism if we again have minimized or potentially eliminated a QT signal. Pimavanserin or NUPLAZID also takes 12 days to get to steady state. We often see that kind of dynamic with serotonergic drugs. It takes two to three weeks before patients begin to see a benefit of the drug. The dopaminergic drugs used off-label have a much faster onset of action. You typically begin to see benefit within a few days. ACP-204, we now know based on human work that we've done, we should get to steady state in about five days. Much closer to the onset of activity that we see with dopaminergic drugs. I mentioned we're in phase I. I think in most cases, if this were a phase I asset, we probably wouldn't spend as much time talking about it as we do. Because this drug is both chemically and biochemically closely enough related, I'll state it that way, to NUPLAZID, it just has a different risk profile. You know, typically small molecules, early development, very high attrition rates. We're working with a mechanism that we know really well. We're working in a chemical space that we know really well. We know that moving nitrogen around this way or that way does this and does that. We're working in a space that's significantly de-risked for a market opportunity that is dramatically large. We're very excited about this program. We're eager to finish up phase I. More to come on our phase II plans once we've done that. Last topic I'm gonna cover is business development. The reason we have a slide on this, it's just a very important part of our business. Trofinetide is a good example of our success in business development. We acquired rights, North American rights to that compound. After it completed phase II, we're now on the cusp of potential approval and launch of that drug. We've done a lot of business development. There's a lot more that we will be doing. My point here is just to simply give you a little bit of additional texture around our plans and what you should expect to see from a business development perspective. We have a footprint both in psychiatry and neurology, broad indications, rare disease. I think Nuplazid is a good example of this. It's a drug to treat psychiatric symptoms, but it's prescribed almost exclusively by neurologists. We're in neurologist offices all the time. Of course, trofinetide is a rare disease. It's more neurology-based. As we go forward, what you should expect to see is keeping a footprint in all four of these quadrants, but the mix will shift more toward rare and neurology. That's really a function of where other companies that you might be hearing speak at this conference and their venture capital investors have been putting their resources. We did a survey a few years ago to see, well, where are VCs investing in the CNS space? What we see is it's been heavily weighted to neurology and rare. There's some really good reasons why that's the case. For a company that grows our business through transactions, that's where the opportunity is for us. The opportunities, I should say, are just richer in those quadrants than they are in the, in the broader indications. We'll continue to have a footprint in all four of the quadrants, but you'll see the mix shift as we go forward. Last thing I'll say about this is we're all very aware of the capital market environment. I've been waiting for this day for six or seven or eight years. You know, as a company that does a lot of business development, the most significant competitor we've had have been you. You've been investing in these companies and funding them, and it's been very difficult to get deals done. You know, it's a different capital environment now, and that really benefits us. We don't need to raise additional capital. A lot of other companies do, and we're already beginning to see the impact of that. It's definitely making companies more amenable, more eager, more actionable, that just frankly wouldn't have been a year ago. If I distill all this down into our near-term milestones, trofinetide PDUFA date, March 12th. Pimavanserin, negative symptoms of schizophrenia, will complete enrollment in the middle of this year. Top line results a little over a year from now. Alzheimer’s Disease Psychosis, our ACP-204 molecule will complete phase I in the first half, and very eager to get this drug into Alzheimer's disease patients soon after that. All right. Thank you very much. I think we'll go to Q&A now. Great. Thanks. Oh, thanks, Steve, for the presentation here. Looking at my clock, we only have about, I don't know, five or six minutes for Q&A, and we have a number of portal questions that have come in from you guys as we've been chatting here. I'm just gonna jump right into them. The first question that we have here is: How is the review of trofinetide going, and have you completed the mid-cycle review yet? The answer is exactly according to plan from everything that we can see, yet we never know exactly what's going on behind the doors of FDA. We have had our mid-cycle review meeting. Our policy is not to talk about the specific interactions we have with FDA when we've got a drug under review. What I can tell you is, from everything we can see in terms of their level of interaction, the feedback we got after the mid-cycle review meeting, et cetera, they appear to be exactly on track with where they should be, and we can assure you they've been very engaged. I'll just compare and contrast for a second. We had an application under a sNDA, so a Supplemental New Drug Application that many of you are familiar with. Under an sNDA, the FDA does not have to hit certain milestones. They're not required to communicate as much as they are under an NDA, and we just frankly didn't get a lot of communication back on the sNDA. This is a very different situation. They've been very engaged with us. And again, we're eager to get to March 12th. Okay. Second part of the question is: Is there any indication that there might be an Advisory Committee? I know that there wasn't back in September. Given how many PDUFA extensions we have seen since the pandemic, do you believe that the review is tracking as expected? Yeah. Sounds like you do. Yeah, on the second part, everything we can see, and again, we're very engaged with them, they appear to be, and they certainly tell us explicitly, we're on track. Okay. I think in terms of an Advisory Committee, when they accepted our application for filing, they said, "We do not plan to have an Advisory Committee." After the mid-cycle review, they reiterated that. It's always possible. I mean, sometimes, you know, I mean, they're human too, and sometimes things come up at the end of a review and they think, "We just need more time to explore this," or, "Now we think we need an Advisory Committee." It can happen. Theoretically, it can happen. At this stage of the review, with March 12th PDUFA day, I think it is exceedingly unlikely that we'll have an Advisory Committee, and the FDA's continued to tell us we do not plan to have an Advisory Committee. Okay, great. Another question that we got through email was just around pricing for trofinetide and, are there any kind of comps we should be thinking about as we kind of think about a potential price here? I'd love to be able to share more of our thinking on this, but the reality is we just don't share pricing guidance until we actually get the drug approved, because the most important conversations you have with payers are those that you have once you have a label. We've done a lot of work with payers. They understand. They get it. This is a rare disease. It's a extraordinarily debilitating disease. I would say, you know, they'll manage it like they would any other rare disease, but typically these rare disease drugs don't have a dramatic impact on their per member per month metric, which they all are, you know, highly focused on. You know, they'll certainly have requirements that... We expect, based upon the interactions we've had with them so far, to have very good access for the drug. What I've said publicly before, I'll just repeat it here, is I wouldn't expect it to be priced the way you see kind of the pediatric epilepsy drugs, where there are other drugs that can treat those conditions. Those tend to be in the $60,000-$70,000 a year range, I wouldn't expect it to be at the high end of the range, where there are some rare disease drugs that approach $1 million a year. What I can say is we'll price it based upon the value that we're delivering and recognizing the extreme impact of this disorder and the ability to benefit patients. I'll just give you one really quick anecdote. I never like to make too much out of anecdotes. I think it's an important illustration. We had one mother in the LAVENDER study who said: Before trofinetide, I had no idea what my daughter liked to eat. She couldn't communicate even yes, no to questions. On trofinetide, she can. I can actually ask her, "Do you like this? Does this taste good or not?" She can tell me yes or no. That doesn't produce a big change on the Rett Syndrome Behavior Questionnaire. It's a very critical and important benefit to that child. Those are the kinds of benefits that trofinetide has the potential to deliver. We'll price the drug accordingly. Yep. Great. Another trofinetide question here. Just on publication of the LAVENDER results, when we could expect those and sort of what the KOL feedback has been so far? I don't have precise timing to announce yet on the publication, but they will be published. In terms of KOL feedback, I mean, they're just desperate for a drug to help these families. It's been very positive, very supportive, very strong. You know, anytime you're launching a drug, what we always like to recognize, there's can be a difference between KOLs and the vast majority of physicians that actually write the drugs, the more, you know, community-based physicians. We've done a, I think, a very thorough job of making sure we've pulled both KOLs as well as just broad-based community physicians to make sure we understand what their knowledge base is, what their sensitivities are, et cetera. That's all lined up very, very well and very supportive. Okay. Another part of the question is just asking about how you plan to build awareness around Rett, just because it is a very rare disease. Yeah. Yeah, great question. Again, physicians that treat it, families have a child that have it, they know it. Because there's been no drug approved to treat these core symptoms, elucidating those symptoms is very important. We're laying a very strong foundation to do that today. We'll continue that effort throughout, you know, post-launch. You know, once you launch, it actually gets easier because now you can talk specifically about your drug. Today, we're just kind of digging the hole without having anything to fill. We're trying to really fine-tune the understanding of these broad array of symptoms and look forward to then having a drug that can help address them. Great. Well, I think we're just at time here. I wanna thank Steve and the Acadia team for being here, thanks for everyone for joining. Thank you.