This session of the Morgan Stanley Global Healthcare Conference. I am Judah Frommer, one of the SMid Biotech analysts here. We are very excited to have Kabir and Lori representing Compass Pathways. Let me just get through a quick disclosure and then we will jump in. For important disclosures, please see the Morgan Stanley Research Disclosure website at www.morganstanley.com/researchdisclosures. If you have questions, contact your Morgan Stanley sales representative. All right, so with that, welcome again. You are at a pivotal time in the company's history. NDA filing and process with rolling review underway, FDA actively working through module submissions, PDUFA timeline guidance with priority review, and launch guided for first half of 2027.
So, with that kind of as the background, maybe for those less familiar with the company and the broader development landscape, I thought we could spend a couple of minutes just on the history of Compass, how you have differentiated your approach versus competitors, and maybe how the team has more broadly progressed psychedelic drug development efforts. I know it is a lot, but.
Thanks, Judah, and thanks. It is great to be here. And just our own disclosures, I will be making forward-looking statements. We will be and please refer to our various risk factors. So Compass was really founded to make psilocybin available through the medical model with broad and equitable access, and that is exactly the purpose we have been engaged on now for the last nearly decade. One of the things that I think is key and perhaps investors still do not fully appreciate is the decision to go into treatment-resistant depression.
So we are working in a patient population with chronic recurring depression, a population that is really very different from an MDD population, where many other things have been approved, and that is a key point of differentiation, and Lori will talk more about that in a moment. As you said, we are in a great place right now.
We are going to complete the submission in Q4. We have a Commissioner's National Priority Voucher. I am sure we will talk more about it, but really the agency is extremely engaged with us. One thing we have to acknowledge as the first likely psychedelic to be approved, we are doing a lot of the heavy lifting. So where we are going, others will come behind us. So when we talk about not only the way we have designed our trials, you will actually see imitation is a great source of flattery. Lots of other people have designed similar trials. Indeed, the FDA's own guidance for psychedelic trials really described our phase III program.
We believe in many ways we have been pioneers, have set the standard in this field. We are just very excited now to be within sight of the next huge milestone of potential approval and launch.
Okay, great. Maybe just a little bit more on the kind of that TRD versus the MDD landscape. Maybe just a little bit on the unmet need in TRD, how the opportunity differs from MDD, and really underscore what is the standard of care for these patients.
Yeah, happy to. Right now, there are currently 55 MDD approved products being used on an annual basis. Five of those are branded, and they are all pricing at innovator pricing. TRD has one, and that is SPRAVATO, which is currently being used. The reason that this is such an important difference to make is there are 4 million patients who actually are TRD. TRD is traditionally defined as the failure of two antidepressants. So 4 million patients out of the 13 million MDD patients that are currently being drug treated is a very large patient pool of patients who only have one option currently indicated for. The difference between MDD and MDD in terms of being able to have this efficacy set that we have proven in this patient population is and comes down to payers.
Payers will, because this product is the only other one that will be approved at the time, will most likely cover us PA to label. That is how SPRAVATO is used today. Again, SPRAVATO made $1.7 billion last year, and only treated 100,000 patients. So there is tremendous pricing power potentially with payers and having efficacy in this patient population specifically.
Okay, great. You mentioned the phase III trial, Kabir. It says briefly here, but maybe just describe the phase III trial design. There were two trials here. There are differences in design between both of them. COMP006 versus COMP005, maybe the various subcomponents and what you were hoping to learn from each of those, and then we'll get into the data.
Absolutely. COMP005 was two arms, single dose of 25 milligrams against true placebo. That was really designed as a safety study, and the dialogue with the agency was around truly establishing a safety baseline. Again, remember, we were the first psychedelic to enter phase III, so that was part of that dialogue. COMP006 is the same three arms that we used in the phase IIb, so the 25 milligram, which we believe was the active dose, 1 milligram replacing the placebo, so not an inert placebo, but something that would have some potential subjective effects, and then 10 milligrams chosen as an intermediate dose, which first, in a fully naive population, would actually help from a blinding and confounding perspective.
We know the agency likes to see a clear dose response to show that this truly is a drug effect, so that was the other part. That is two fixed doses-
three weeks apart. Primary endpoint in both 6 weeks. Also both running fully blinded to 26 weeks, which is, I think, unprecedented in depression trials, but certainly pretty unusual. We really knew even though we designed these trials before the FDA issued their draft guidance, the durability was going to be key, not only from a regulatory perspective, but as we'll come on to discuss, absolutely from a commercial perspective as well.
Okay, great. With that in mind, maybe we can walk through key learnings on both safety and efficacy from the phase III program. I thought we could touch on MADRS reductions, responder remitter rates, and safety specifically, but help us with what has resonated most with practitioners as well.
Yeah. I'll briefly touch on the data and then hand to Lori to talk about how we see that translating into real clinical and commercial practice. In both studies on the primary endpoint, highly statistically significant results, we saw a separation of just under four points in the change from baseline on MADRS. Again, in this population, and again, just to perhaps belabor the point of this Treatment-Resistant Depression population, the average duration of the current episode of depression was three to four years in our trial. This is truly a population that, while to enter the trial, had to have failed at least two antidepressants in the current episode. Typically, over the course of disease, have tried multiple medicines and really nothing else is working. So very much a chronic refractory population.
That just under 4% MADRS difference, four-point MADRS difference, is highly comparable to SPRAVATO in a similar population. What's really important, though, is we saw rapid onset. If this drug is going to work, you will know within 24 hours. We saw with one administration, roughly a quarter, and with the two, three weeks apart, 40%, having a clinically meaningful response. Then what we see is with an additional dose, either three weeks apart in COMP006 or at a more variable time point in COMP005, we actually see durability all the way extended out to 26 weeks.
What you're seeing is a combination of very rapid onset, durability from one or two doses, now supplemented by the 52-week data from COMP005, where we actually see that a potential third dose also has the same efficacy as a first or second dose and extends durability out to a full year. That combination of rapid onset, durability, limited dosing is remarkable from an efficacy perspective, and it's generally safe and well tolerated. I mean, the vast majority of adverse events are transitory and resolve on the day. They are day of dosing, nausea, headache, some fatigue. Not surprising, this is a fairly intense experience on the day for a patient, but overwhelmingly resolved with the first day or two. Moreover, we see on repeat doses and so on, we actually see some potential trend towards lessening those side effects.
I will now hand to Lori to translate that into what that means. Sorry, that was a lot.
There are team members in here of mine who can attest to this, but when I first saw our data represented in a graph form, I almost cried. I mean that literally. These are a very, very sick patient population. These are treatment-resistant depression. By the sheer definition, they have not had efficacy on other products, and they are in a severe state of depression. What our trials showed in both COMP005 as well as COMP006 is that these patients saw a dramatic drop in their MADRS within 24 hours of their day of dosing. 24 hours. As Kabir said, the average duration of depressive episode for the patients that went into this trial was three to four years. Can you imagine living your life three to four years depressed, and then you have this one treatment, and the very next day you feel better?
That is why I almost cried. What made me have even more tears was the fact that what we were able to see achieved was actually in a COMP006 with an additional dose or a COMP005 with part b, that durability lasted out to six months. This is contrasted against, again, the only other product approved for treatment-resistant depression, where these patients have to go in at least every other week to maintain their efficacy. This has become a very highly burdensome treatment paradigm for patients and their caregivers because SPRAVATO patients have to be driven home by a caregiver. Our patients will have to be driven home, too, but that is contrasted versus one or two, maybe three times in a year, versus 52 times a year.
Maybe just spend a minute. We hear from time to time that MADRS is great for a clinical trial setting, but it is not the most relevant endpoint for practitioners. Responder remitter rates, I guess, have those stood out more for clinical practitioners? Maybe just frame those for us.
Yeah. I think you are absolutely right, and physicians are not typically taking a MADRS score. Response and remission is important, but typically, a psychiatrist takes a more holistic view of quality of life and so on. Yeah. So what we saw in COMP005 was remission rates were around just under 10%. Full response rates were around 20%. We saw that improved in COMP006. What I think is really exciting is what we have just seen in the 52-week data from COMP005, which is now clearly open label, but therefore much more representative of the real world. And there we saw across both placebo patients who were getting a first dose or those on the 25 milligram arm getting typically a third dose. You are seeing actually remission up in the 30%s and 50% response up in the 40%s.
And to us, that is much more analogous with what you are likely to see in the real world where people know what they are getting.
Okay. That is helpful. Then maybe just back to dosing frequency, like you said, patients have gotten one, two, or three doses. Just I guess better contrast that to SPRAVATO, whether it is in the first year or if patients are continuing.
Yeah. So let me start by saying what we believe our label will say.
What we believe the label and the dosing administration will say is two initial doses, minimum of three weeks apart. So analogous to what our COMP006 trial was. That is very important because there are two things to think about, what we saw in COMP005 versus COMP006. If a patient responds after the first one, that does not preclude. There is no reason why they need to take the second one.
A physician will make that decision. We believe that the two initial doses does give a patient a much more dramatic and longer durability. The maintenance period, we will not say maintenance, but in effect, what is contrasted to the SPRAVATO label maintenance period, will say redosing upon physician discretion. The commercial team will help educate sites and physicians on what to look for, what to expect from their patients. They will get clinical experience, they will understand at the time of redosing. We do expect the minimum to be somewhere between two and four annually.
I know that is three on an average. I can do math occasionally. We do expect there to be somewhat of a range, and that is how we will price. We can come back to that later, but that is what we are looking at. For SPRAVATO, by label, their initiation phase is twice a week for the first month, once a week in the second month, and then every week or every other week for a maintenance period forever. There is no endpoint. You have to compare and contrast what that burden is for a patient o f either two to four days off of work, their caregiver days off of work versus potentially 25 to 52 times in a year having to go in for SPRAVATO.
Right, okay.
What you also had to recognize is because of that patient burden, in practice, few patients get beyond seven or eight months on SPRAVATO, and of course, they are then not necessarily better. So that's a suboptimal treatment, both from a patient's, clinician's, and importantly, a payer's perspective as well.
The frequency of treatment also with SPRAVATO does limit the radius at which patients can feasibly go into a center and get treated on that frequency of the basis. When you're going in two to four times a year, that definitely opens up our radius of patient populations.
Okay. So maybe just on that point, maybe just walk us through the current SPRAVATO infrastructure set up today. Why it could represent a sort of a running start for COMP360, and maybe at the same time, what are some of the areas of confusion for investors in assessing whether SPRAVATO and COMP360 are both attractive from a provider perspective?
Yeah. So I can answer both of those without directly answering both of those.
Great.
So right now, there are 8,500 sites that are currently available to administer SPRAVATO. What that means is effectively that they are prepared to administer multi-hour treatments, SPRAVATO being the only psychiatry pharmacologic product out there that is multi-hour. It also is very important for me to note that a REMS certified SPRAVATO center is ready for COMP360. The rooms are the same. The staffing requirements will be the same. Getting a PA through REMS requirements outside of the hours needed for monitoring should be highly similar. So there's nothing that the sites that are currently existing for SPRAVATO needs to do to get ready for a COMP360. They're already ready.
That, I think, is the fundamental miss from investors. On top of that, they have capacity. SPRAVATO sites are growing at about 500 sites a quarter, and that is impressive. SPRAVATO is a very good drug, but these sites are growing because they understand that psychiatry, particularly depression, has multi-hour products coming behind it. These sites are getting prepared to have multiple options. Again, the current sites are not at capacity, and they are only treating 100,000 patients out of 4 million in TRD.
Okay. Great. Then maybe just touching on the regulatory side, just remind us of your FDA interactions and designations thus far, your breakthrough therapy designation. I think it is called a Commissioner's National Priority Voucher at this point.
Yep.
How have those factored into level of communication with the agency and the frequency?
Yeah. You are absolutely right. We have had breakthrough designation since 2018, and now we will receive the Commissioner's National Priority Voucher in April. I think the first thing to say is, throughout the development of COMP360, we have had a really good relationship with the psychiatry division. We were one of the earliest to move forward, but there have been other companies in parallel as well. I would say that the division truly has an appreciation of the potential of psychedelics. They have said publicly that between a third and a half of everything under review is now psychedelics. Putting it in context, we already had high level of engagement. They have already been putting out draft guidance and so on. With the Commissioner's National Priority Voucher, that really means two things.
First, at the back end, there is the target of approving it once the submission is complete within 60 days, and that will be very nice to have at the back end. I think much more importantly, it has led to a fundamental difference in the way the day-to-day interaction goes. We have got a rolling submission underway, and we also genuinely have a rolling review underway. Sometimes you had one without the other. We are getting information requests. We are turning them around. We actually have a draft label already under review. The REMS framework is under review. We have already submitted the eight factor analysis for rescheduling, and there are inspections happening as early as this week.
I would say that the level of engagement, interactivity, the lack of the formal bureaucracy and timelines that used to govern FDA interactions has been incredibly refreshing. At the same time, the division has been very clear with us that there is no change to the standards. Yes, they are going to hold us to exactly the same standards they would ever have held any other psychiatry drug to, and we think that's exactly right. We are very happy with where we are at.
We will complete the submission in Q4. We honestly do not know if there will be the typical 60-day acceptance. That could be that even though we have done a rolling submission and rolling review, then we expect the clock to start with a potential 60 day. We do think they may still issue a six-month PDUFA and beat it. But again, there are so few precedents for any of this at the moment, it is not quite clear.
Okay, great. That could set you up for a launch, I think you said as early as the first half of 2027. Maybe just give us an idea of how investors should think about adoption. What are key factors to pay attention to following potential approval? I think you have said recently, there could be a slow ramp out of the gate, but there could be some snowball effect as experiences gain. I guess what metrics should folks be paying attention to, and what timeline should we be thinking about?
Yeah. Let me just reorient people to the timing of launch and what that might take, because I think that's very important to understand. As Kabir just alluded to, the timing of approval will be a little bit fluid. Hopefully, that's understandable. The DEA needs to reschedule. Because this is a Schedule I product, they will need to federally reschedule it. Given the executive order, that could be anywhere from 1 day to 90 days after approval. Again, we're doing everything we possibly can as a company to make sure that that's done in an expedited fashion, but it really is out of our control. What is in our control, though, is to making sure and helping states reschedule as well. Because after federal reschedules, the states need to reschedule.
Once the states come online and reschedule, we can then legally ship as well as physicians can legally prescribe the product in their states. We've done a tremendous amount of work over the past two years to make sure that as many states as possible are intending to reschedule within 30 days after federal. Right now, 93% of the population lives in a state that will reschedule within 30 days, and we're continuing to do work. By the time we launch, that number will inevitably be higher. The reason we're thinking about a slower launch is not because of demand.
We have almost an unheard of demand from not only excitement from physicians, but also patients, and patients that we're speaking to. We're not concerned about demand at all. What we are concerned about is making sure that sites get reimbursed and they have no reason not to prescribe, and that they are well prepared to administer the product. We are very focused on making sure that patients have a good experience. We know that fundamentally, if those two things go wrong, our launch will derail pretty quickly. Not only that, we will derail it for the entire class. We're taking that very seriously. We're going to spend a lot of time making sure that sites can get reimbursed appropriately. A little bit of hand-holding, white-gloving it, if you will.
More rare disease type, making sure that sites are adequately prepared and that reimbursement is not a hurdle for them, as well as making sure that patients are well-educated and prepared. That inevitably what may mute the launch a little bit, but once these sites get clinical experience, they know they can get reimbursed for the time that they're spending, as well as the product can get reimbursed for the patient, that should skyrocket pretty quickly.
Okay.
Yeah. We also think that word of mouth, peer to peer, both at provider and patient level is going to be critical here, which is why those early experiences need to be positive.
Exactly.
How are you thinking about REMS, I guess, relative to SPRAVATO? Presumably monitoring time would be different, but anything else you'd highlight?
No, we don't expect anything outside of what the REMS requirements are right now.
Yeah.
In fact, we've had early discussions with the FDA to guide us towards that. Where this lands, we'll see, but there's no reason to believe that it would be anything outside of SPRAVATO requirements, basically, other than the time required.
Okay. And maybe just coming back to the addressable population a bit, do you have a sense for proportion of TRD patients that are receiving any interventional treatment, whether maybe it's SPRAVATO, ECT, TMS, beyond pharmacological even? And of these, do you get the sense that there could be a switching dynamic when COMP360 potentially comes to market? Or are de novo TRD patients more of the initial target?
Yeah, it's a great question. Right now, SPRAVATO treats about 2% of the TRD patient population. ECT and TMS treat about another 2%. Less than 5% are actually receiving any treatment-resistant depression indicated product. That's out of a patient population of about 4 million. The capacity to grow the market is sitting ripe for another TRD indicated product to come to market and really start to make sure that physicians are well-educated on treating with appropriate medicines. The switching one is an interesting one. Will there be switching? Absolutely. It has to do with the fact that what we just talked about, the burden of SPRAVATO is high.
Is that who we're going after? Absolutely not. These are treatment-resistant depression patients. If they're stable on SPRAVATO, please stay stable. We don't want to risk that. There will be some switching, we know that. We know that from patients we've engaged with. The patients we will be going for are patients who either are coming in de novo, and we know that that demand is there. The sites are already telling us that they have a waiting list of patients. There's plenty other ways of attracting patients, not only from us doing marketing and making it aware, but also the sites are attracting patients.
Yeah. The real patient need here is to move psychiatrists and so on to recognize TRD much sooner than they do today. That is why we have already started disease ed and so on around that, because while the technical definition, as I say, may be two failures, being failed by two drugs in the current episode. In practice, so many of these patients have been cycled through multiple drugs that have not worked, and that is the real opportunity. There is a huge pool of patients there for us to go after without needing to target SPRAVATO or anything else.
That is right. We just launched our Change the Tune in TRD disease state education website, and we are premiering it at Psych Congress right today.
Right. Nice.
We are very excited about increasing disease education. Mostly, this is a pharma world. There is a lot of interest and uses of MDD products because that is all that has really been available to psychiatrists. Now we actually are proving efficacy in this patient population, and the more people out there talking about efficacious treatments for this patient population, the more that pie will grow.
Okay. Maybe just coming to reimbursement, right? I think there are maybe questions around reimbursement for clinicians in these centers. You've said you'll have a field reimbursement team fully deployed at launch, so clearly, you're on top of it. CPT codes, we have to touch on, as always. Where are we currently? Where are they headed? You've done a lot of work to lay the groundwork here. What's the process and timeline for getting these to category 1?
Yeah. There are a couple of things I want to make sure we highlight, and one is no site should be disadvantaged versus providing SPRAVATO. Right now, SPRAVATO uses general evaluation and management codes. They will be the exact same codes that they will use for COMP360 reimbursement until our category 3 codes get moved to category 1. There is no possibility of there being a disadvantage here. I want to make that very clear. The reason the field reimbursement team becomes very important is, one, to make sure that the sites understand this, but also so that they can attach the CPT III codes to the reimbursement.
The more pings to payers, the more proof that these are actually being used, the faster it will move up to category 1, and the codes can get assessed at the value that the sites are actually administering, which we believe should be higher currently than what the general evaluation and management codes are today. The faster it will move up. But there will be some time, and we have to be honest about that. There will be time, naturally, until we prove usage in this.
Okay, great. You touched on it briefly, but I guess, just on pricing and you talked about dosing being that two to four annually. I guess, what have conversations with payers sounded like? How receptive are they to the unmet need in TRD?
Yeah, I have been doing this for a very long time at this point. I have never had payers as interested in talking to us. Now, that I will fully admit that doesn't mean anything, but it is a very good starting point. Usually, companies have to go out to payers and beg them to spend time with them to show them the data. We are having quite the opposite effect. We are having great interactions with payers. Payers truly understand the burden that treatment-resistant depression is adding to the payer system, and they are very excited not only about the dramatic reduction on day 1 within 24 hours, but how long this actually lasts with only one dose, maybe two doses. We are very encouraged with where we are at.
Okay, great. Maybe just a little bit on competition within the broader space, which is probably a good thing to see kind of.
Totally.
More psychedelic drugs moving through the clinic. But for those utilizing shorter duration psychedelics in the treatment landscape, we have seen some acquisitions. I guess, do you get the sense that clinicians and patients are excited to have multiple options, and these are subjective experiences potentially?
Yeah. I think the important thing to stress here is that, first, we do welcome more psychedelics coming through. The growth of these clinics, as we said earlier, is not being driven by SPRAVATO. It's being driven by the expectation that there will be multiple coming. Another dynamic we haven't even touched on is buy and bill now accounts for 35%-40% of SPRAVATO. As you see more products coming through, you'll see more and more psychiatrists seeing that there's a business opportunity here across multiple products. But in terms of actual products themselves, a couple of points here. First, we've talked about the unmet need. There are vast numbers of patients across TRD, MDD, GAD, PTSD, and so on.
So, in the same way as there were multiple SSRIs or antipsychotics that reached multiple billions, I think you'll see the same. The second, though, is duration is only one element, and truly only one element of the differentiation between these products. So psilocybin is a relatively gentle experience. Yes, it comes with some inner-directed work that can sometimes be challenging to work through. But physically, it's actually a very stress-free experience. Yes. Somebody's got eye shades, listening to music, and so on. Some of the shorter acting are physically challenging experiences both for the patient and the provider. First, they are several years behind us, so until we've actually seen phase III data around the profile, we don't know. But I do think the nature of the subjective experience and how different they are is also going to be an important element of provider and patient choice.
I agree. As Kabir alluded to, these sites are growing because more options is better for business. Also, there is a tremendous unmet need for patients.
Right.
This is psychedelic sort of future. I stand behind that.
Great. Maybe I want to make sure we touch on the PTSD program. What should investors be looking for in terms of updates from the ongoing phase II-B/III in PTSD? Maybe just spend a minute on how that opportunity differs from TRD.
Sure. Why don't you start with u nmet need and the demographics.
Yrah.
The unmet need is potentially larger than the treatment-resistant depression opportunity right now. This is why we are so excited about PTSD. PTSD is about 13 million patients. The last product was approved 25 years ago, so there has not been any innovation in the space in a very long time. We do hear a lot about veterans and PTSD. Obviously, that is an important area of concern for us. They actually only represent about 15% of PTSD patients. So it is important to note that it is far reaching beyond just the VA and veterans. It is 60% women, and there are plenty of opportunities. The most important thing to note is the synergies are incredible here because PTSD patients will be treated in the exact same centers as the current infrastructure for depression.
From a design perspective, essentially, we have mimicked COMP006 in this single late-stage registrable space. We decided, even though we had done the open-label study of single dose, based on what we saw from COMP006, that suggests that a second dose can deepen the impact. This is a two fixed dose study. 25 milligrams, again, we believe will be the effective dose here. Again, we have the same intermediate dose from a blinding perspective and so on. The primary endpoint is at eight weeks just because CAPS-5 is a four-week look back, so it has to be at eight weeks. Primary endpoint at eight weeks, blinded to 12 weeks, open label thereafter for a year. We have designed it in a way that we believe it can be registrational. The agency has already agreed that from a safety perspective, much of what they already know translates across.
We hope and believe with the emerging flexibility within the agency, that this single, very large, robust study should actually be sufficient. Over time, the study is now up and running. As we get more into recruitment and so on, we will be able to update on timelines. Right now, we cannot give any guidance for that.
Okay, great. I think with that, maybe we will move in the last couple of minutes to a mini survey we are giving all of the biotech management teams, and some of these may be less relevant, but curious to hear your responses. The first topic is just on China's rise in biotech innovation. Any thoughts on competitive positioning, whether it could affect business development and strategy?
What I will tell you is that one of the best-known analysts from another bank went on a trip to China, and his report, what he wrote was, "The only sector I cover that does not need to worry is psychedelics," because none of them even knew what the word meant.
Yeah.
So no, honestly, and having worked in China myself, albeit a long time ago, I spent three years there. The treatment of serious mental illness is still in a very different place even now. I do not think China specifically is somewhere that we regard as an area for potential. That said, we are very interested in NCE development, new things that are coming through in the broader psychedelic pipeline. If some of that innovation came from China, we would clearly be open to that.
Okay. The next topic is AI. I guess, can you talk about how Compass is leveraging AI or thinking about potential disruptions from AI?
Yeah. So we are leveraging it, as you would expect, as a productivity tool, essentially, widespread across the whole business and a mix of using third-party resources, plus some really interesting ones inside. So, I will give you a good example. Obviously, our dossier is huge, yes? Massively cross-referenced and so on. So our internal team developed a very powerful tool that is actually dealing with all of those cross-references, getting out duplications and so on and so forth. So yeah, we are using it as a tool broadly. We do not do drug discovery. So yeah, that's not relevant for us from a discovery place. And on the commercial side, we will again be making extensive use as we roll out tools.
Yeah, productivity is incredibly enhanced by AI, and we are putting in place right now, and really, we are also highly regulated too. It does help from that standpoint, but there are lots of programs available right now that can help increase the productivity of sales reps in particular.
Okay, great. And last one, just on regulatory, I guess which aspect of your regulatory interactions or strategies are most impactful? FDA, pricing, tariffs, anything else?
Yeah. From our perspective, it really is the FDA.
Yeah.
Clearly with the NPV and so on. As I just hinted at as well, I think it's not just what we've been able to do with our core phase III program in TRD. We're excited about the opportunity for future flexibility, for instance, a single PTSD study being potentially registrational. The other area, which I think is going to be really important, is real-world evidence. Historically, psychiatry has not been open to label expansion, indication expansion through RWE. I think we see a potential open door there because we will be collecting a lot of real-world evidence as we roll out.
Great. All right. We will leave it there. Thank you again, guys.
Thank you.
Thanks very much, Judah. Thank you.
Thanks for having us.
Thank you for having us.
All right.
That was great.
Great. Yeah. Thanks for doing this.