Good afternoon, everyone. Welcome to the next session with COMPASS Pathways. I'm Ami Fadia, Biotech Analyst here at Needham. It's my pleasure to be hosting the team today. We've got with us Kabir Nath, who is the CEO of the company, along with Steve Levine, who is the Chief People's Officer. Chief Patient Officer. I'm sorry, I got that wrong perhaps. I'm sure I did.
Thank you.
Teri Loxam, Patient Officer. Lori, who's Chief Commercial Officer. Thank you so much to all three of you for joining the conversation, and I will turn it over to Kabir.
Thanks so much, Ami. Thanks for the invitation, and it's a pleasure for us to be here. Just as I start, just a reminder, I will be making some forward-looking statements, so please do refer to the many risk factors outlined in our various filings to the SEC. COMPASS Pathways is the leading psychedelic company. We're the company that is potentially closest to a regulatory approval for a classic psychedelic. We are in the midst of our phase III program for treatment-resistant depression, and a couple of months ago, we put out a significant amount of data. In that, we declared the primary endpoint from our second phase III study, which is one using two fixed doses of 25 mg of COMP360, our proprietary synthetic form of psilocybin.
We also gave more details around the primary endpoint of our first phase III study, which is a single dose of COMP360, and that was compared against an inert placebo. We had put out the top-line last year, but in February, we put out the comprehensive primary endpoint data from both of those studies, plus the 26-week blinded data from the first study. What have we seen? In both studies, we saw a highly statistically significant difference in change from baseline on MADRS for 25mg compared, in the one case, to placebo, and the other to one milligram. Highly statistically significant, a clinically meaningful difference. What we saw in our first study, COMP005, 25% of patients had a clinically meaningful response to COMP360, defined as a more than 25% reduction in MADRS.
A good point to remind you that this is a treatment-resistant depression population, a population that is historically very hard to achieve a difference in, a population where, as we'll go on to talk much more about, there is in fact only one approved and used drug today. 25% of patients in that first study, a clinically meaningful difference in their symptoms based on MADRS, and from one or potentially a second dose delivered somewhere in around week 10, an effect that lasts out to 26 weeks. Really a redefinition both of rapidity and durability for depression. We see the onset immediately. We take that first measure at the beginning of day two, and we see that immediate onset. As I say, from one or two doses, we see durability out to at least 26 weeks. These studies run fully blinded to 26 weeks.
This is a true, robust clinical finding. The second study, the primary endpoint, we have only that data so far at six weeks. What we see there is with a second fixed dose, we see 40% of patients achieving that clinically meaningful response. We will be very excited to see the 26-week data from that second study to see to what extent we sustain that, and again, whether a potential third dose there really pushes durability out further. Again, compared to anything that's available in depression today, this really is redefining rapidity and durability of response. The safety profile, it's well-tolerated. We see a number of transient adverse effects on the day of dosing, headache, nausea, fatigue, that are what you expect of what is a profound psychedelic experience on the day, overwhelmingly resolved within 24 or at worst 48 hours.
The independent DSMB has been monitoring both of these studies throughout and provided a statement that says across the body of work and all the data they've seen to date, they have seen no clinically concerning imbalances around suicidality or suicidal ideation. We've had a very active dialogue with the agency. We've had breakthrough designation for TRD now for some eight years. With this data, we have aligned in principle with the agency on the potential for a rolling submission. That process is now underway, and we expect now to complete the NDA submission with that 26-week data from our second study in early Q3. That will be the final item to go into our submission. With that, we would expect to complete a submission in the back part of this year. With breakthrough, we can anticipate a priority review.
While we're not giving formal guidance for when a PDUFA date may be, what we have said clearly is we will be ready commercially by the end of this year. Lori will talk about the plans that we are building and so on for that. Again, very exciting times. The company, as I say, potentially closest to a really paradigm-shifting approval in treatment-resistant depression, the first potential psychedelic, and we'll be delighted to get into any more details about any aspect of the program. With that, that's our introduction.
Great. Thanks, Kabir, for that great introduction. So clearly, I think this is a much-awaited time point where we're going to see the first psychedelic to go through the final regulatory review and come to market. Of course, we have seen something similar, not exactly a psychedelic, but in ketamine, where we've seen J&J sort of go through some initial teething issues, and now we are seeing that product really ramp up and continue on its strong growth trajectory. So as the first psychedelic to come to the market, but with the backdrop of some of the groundwork that may have been put in place with ketamine, how do you see that positioning yourself in terms of building awareness, leveraging the infrastructure, et cetera, that has been put in place as you think about the go-to-market strategy?
Absolutely. To your point, it absolutely is helpful to us that J&J, with the launch of SPRAVATO as ketamine, has been enabled to build that infrastructure. I will hand first to Lori and then to Steve, who have no more favorite topics to talk about than this and how ready that's going to make us for commercial launch. Lori first and then Steve.
Yeah. Thank you, Kabir. Yeah, the infrastructure that has been built for SPRAVATO and is growing rapidly as you discussed, it's almost hard to keep up at this pace. We are six, seven years past launch for SPRAVATO, and they are still adding about 500 sites a quarter that can potentially prescribe SPRAVATO. They are adding sites at a pace that is extremely rapid. Again, this is seven years post-launch. Their growth trajectory, both from revenue as well as patients and prescribers, just continues to grow at about 50% year-over-year. This growth is obviously setting the stage for an easy entry of COMP360 into these sites because these sites, once they are set up to provide SPRAVATO, can easily add COMP360 into their infrastructure.
These sites, once they go through the REMS certification process for SPRAVATO, are basically attesting to the fact that they can administer multi-hour treatments. A SPRAVATO site, a SPRAVATO room, is a COMP360 site and potentially a COMP360 room. This infrastructure build that has been built out over the past six years with SPRAVATO and continues to be growing is only ensuring that we will have plenty of opportunity to have COMP360 fully and easily integrate into these sites that are already operational. I'll kick it over to Steve to talk about an important topic about this infrastructure that's built, and that is, given they are multi-hour treatments, there's an important component to think about here in terms of provider economics and how we are ensuring that the providers are adequately reimbursed for the time that they'll spend administering COMP360.
Thanks, Lori and Hi Ami. Yes, as Lori and Kabir have just said, while we will most likely be the first-in-class classical psychedelic to be approved in psychiatry, SPRAVATO was the first interventional pharmaceutical product, right? It is a drug that needs to be delivered in a supervised office setting that has a multi-hour administration, and as such, has really laid much of the groundwork that we need in order to know how this will be taken up by these centers, delivered by prescribers, supported by a multidisciplinary care team. That's how these centers operate. They tend to run multiple rooms simultaneously. Today, they're delivering esketamine, SPRAVATO, as well as TMS, Transcranial Magnetic Stimulation, but they're built as a platform or an ecosystem to onboard new FDA-approved treatments for this population as they become available. As Lori said, fortunately, a SPRAVATO room is a COMP360 room.
We expect them to be used interchangeably. The workforce, the staffing that's supporting the delivery of these treatments today is the same as would be required for COMP360. To where Lori left off, the point on some of the important considerations for the motivations of these sites to deliver this treatment, first, hopefully, it starts with the direct patient considerations, with what Kabir led with in the unprecedented rapidity and durability of effect that we are seeing in our trials, and a safety profile that is generally safe and well-tolerated. When you think about what the patient experience is today, as well as their caregivers receiving SPRAVATO, where they need to come for two treatments per week in the first month, that's eight treatments in the first month, and then weekly in the second month, and then maintenance, which for the majority of patients is still weekly.
That represents 25-50 three-hour treatments that they need to be driven to by a caregiver in a year, and that is a very high burden. It's often a few weeks, if not the full month, before you're making a determination of whether SPRAVATO has benefited that patient. What we see with the emerging profile of COMP360, and very much in contrast, is very rapid information about whether this treatment will be of help, and if so, one or two treatments may have a durable effect out to at least six months. With that, we think that alone will be highly compelling for these sites and in the consideration for their patients should they need an economic motivation as well.
Fortunately, this is highly favorable for them in the sense that one of the difficult things in going first for J&J was there not being a reimbursement framework in place that would ensure that these providers are adequately reimbursed for their time of monitoring patients in their office. In lieu of that, what's evolved is kind of a patchwork of existing general office visit codes, which does provide sufficient reimbursement in most providers' minds. That's why they are delivering it to patients. It's not optimized. It doesn't fully capture all of the work being done by the team or the expenses to the practice in terms of compliance with REMS and ordering and storing and handling a controlled substance, some of the other administrative work.
Taking a note from that and understanding this infrastructure very well, we started early with establishing a new reimbursement framework and collaborated with others to apply for new CPT codes. These are the codes submitted by providers for reimbursement by payers for their services that are specific to the administration day of a psychedelic treatment. Those codes are approved. They are live. That is ready and waiting. Because they are tailored to the treatment, we'll more comprehensively capture all of the work done, all of the practice expenses, and, importantly, they're reportable on an hour-by-hour basis. Regardless of the length of the treatment, they will be fully and optimally reimbursed.
In the case of COMP360, given we expect this to be about six hours of observation, it means that in terms of the reimbursement of a room on both an hourly basis as well as for the day, that this should compare very favorably to how they're being reimbursed for needing to put multiple patients in that same room with SPRAVATO today. I think you're on mute, Ami.
Thanks for letting me know. A couple of follow-ups to what Lori and Steve, you both mentioned. Just from an operational perspective, I think Lori mentioned that the type of person or the qualification of the person that would supervise or oversee the patient while they're in the clinic is going to be very similar to what has been used with SPRAVATO. From a training perspective, is there some retraining that's going to be required that's more tailored to COMP360? How would you go upon leveraging, while a lot of these clinics are REMS certified for SPRAVATO, what additional sort of work or qualification or training is required to sort of fully equip them from an operational perspective to use or prescribe COMP360? Maybe a follow for Steve, but I will wait for Lori's response first.
Actually, I think Steve is probably better suited to.
Oh, sorry. Okay.
I'll answer the first question. We'll let Steve chime in there.
All right. Please supplement, Lori. Yeah. First, let's make a differentiation between training and education. I'll take education first and just quickly dispatch with that. We will educate in various ways. Some education has already begun in terms of having our field medical science liaison force out in the world talking to healthcare providers and KOLs and so on about the disease state, about treatment-resistant depression, discussing the data, some of the data we've generated to date, and so on. We will continue to educate as appropriate. Of course, if we have an approved product, we will also be educating through a sales force, through patient engagement and various other activities. More to your question, today, in terms of who is supporting patients receiving SPRAVATO, this is typically a multidisciplinary care team.
There's typically a prescriber on-site who may be a psychiatrist, or it could be a nurse practitioner or a physician's assistant in some cases, and then some mixture of nurses, medical assistants, technicians. Perhaps there's a single therapist on-site. They are collaborating on the care of multiple treatments operating simultaneously. In terms of the training that they receive as part of receiving their degree, of course, to date, that has not, in most cases, included training in psychedelics, although that's increasing. There's been a big push to start to implement psychedelic education and training within degree-granting programs. That will evolve over time, and that will help to supplement things.
In the meantime, it's important to know that there are many existing training organizations of high quality that have already trained thousands of healthcare providers in at least foundational principles of psychedelic care, if not specific to psilocybin, and certainly generalizable across classical psychedelics. To date, there hasn't been much of an application for these trainees to use what they've been trained to do. They've done this in some cases in supporting patients having ketamine. We know there are a couple of state-level programs that have some framework for psychedelics. Really what they've been waiting for are FDA-approved products to be able to use what they've been trained to do. Our plan does include giving credit for training already received. With that, many of these workforces are already most of the way there to being trained to be able to deliver COMP360.
We did make an announcement this morning that we will additionally provide some grants to training organizations to develop not only foundational psychedelic material, but COMP360-specific material. What we will expect and what we will work with them to develop will be that COMP360-specific component, which will fall on the other side of approval, which is intended to be a limited number of hours and costs to make this accessible to any organization that is interested in training. We do not want anything about this to be onerous and a barrier to training and adoption. The bulk of training, again, can fall on this side of an approval and can supplement the thousands of HCPs that have already been trained.
Excellent. I think that's helpful to understand. Maybe going back to the economic model. I think it was very clear with regards to what you said about the CPT codes and how they are going to keep things at par with whatever number of hours of investment that the clinic is doing in terms of monitoring the patient relative to, say, SPRAVATO. Where do you see the buy and bill aspect of the economics, and what portion of the economics is the buy and bill component as opposed to the monitoring and all the other work that goes into storage and dispensing and following the REMS requirements for a clinic? Maybe if you can talk to the buy and bill component and maybe just give us some initial insight into your pricing strategy there.
I'll jump in, Steve.
Sorry.
Yep. You almost had it right, just backwards.
Yes
Who would answer. For buy and bill, we will enable buy and bill. Right now, psychiatry is not necessarily very used to doing buy and bill. It's obviously very common in other therapeutic areas and entire platforms have been built out around that. SPRAVATO is leveraging buy and bill right now at sites. We estimate 30%-40% of their volume is going through buy and bill. That is a very hard estimate, but we feel pretty good that that's about where it's sitting, and that's pretty easy to understand if you think about the concentration of prescribing that's happening with SPRAVATO. Of the 7,300 sites that are actually available to administer SPRAVATO right now, 80% of the volume comes from less than 1,000 sites. Very heavy volume sitting in a very small concentration of sites.
We will enable buy and bill as a component and potential opportunity for sites to recognize some additional economic benefit. In terms of pricing, I really, really want to tell everyone what our price is going to be because we get asked that every single day almost. Right now, we're really waiting on that second piece, the Part B of COMP006, to really understand what our dosing frequency will be, because that will heavily inform what we set our price on.
Yep, that makes complete sense. Okay, great. Maybe if you could talk about the metrics that you guys are going to follow internally to be able to think about what are the key elements where progress needs to be made, whether it's site activation, whether it's training? Maybe if you can talk about that, and what would you be communicating externally to the street with regards to the progress against that?
Kabir, I assume you want me to take that one?
Yes, please.
First, let me just make sure you understand. Our North Star is really to make sure that we are enabling a very positive site and patient experience. We're going to do everything we possibly can to make sure that patients are as prepared, either through education or support materials, or even support through the entire process, as well as making sure that the sites are, as Steve mentioned, adequately trained to have this positive experience. With that in mind, the metrics that we'll be following actually aren't too dissimilar to other launches in terms of how we're thinking about things. Infrastructure readiness will be obviously the first one that we're going to be ensuring, and that will be making sure that REMS certifications are getting through as well as the training that Steve mentioned, that these sites are set up.
Really ensuring that the infrastructure and the sites that we'll be administering are there, we'll be monitoring adoption, scripts, obviously. We'll be monitoring prescribers, number of patients on therapy, again, not very dissimilar to normal antidepressant launches. We'll obviously be also thinking through payer coverage and as that comes on and how that looks and what that looks like, and communicating that. The most important thing, though, that we will probably start communicating at a very early time period on top of the infrastructure readiness will be the state rescheduling. After DEA, the states then have to reschedule. In order for a prescriber in a state to prescribe and us to be able to ship that product to that state, that state needs to reschedule following federal DEA.
That will probably be the most important thing that we're monitoring immediately after launch and DEA rescheduling, as well as the REMS certification and site readiness.
Maybe just regarding the scheduling or the rescheduling, what is the normal expected time to expect that decision to come? I'm not sure if there is a hard and fast strict time that's always followed, so if that isn't the case, then what would be the fallback plan?
Yeah. The statute is 90 days. Now, I don't know what the consequences are if they don't hit 90 days, but the statute is 90 days. For the most part, over the past decade, and there's only been a handful, so we only have a handful to go off of. Over the past decade, they have come very close to that 90-day time period after FDA approval to DEA rescheduling. In some cases, they do it sooner, some cases it's just a couple of days later. Very good so far in that 90 days. We are expecting those 90 days. You have the states that need to reschedule.
Just because the federal reschedules, obviously, again, going back to what I just mentioned, is that the states have to reschedule in order for physicians to be able to prescribe and us to be able to ship that product to patients. Right now, we are working to make sure that that time period is very short after federal DEA, and we're working to try and ensure that it happens within 30 days. There are probably 25-30 states right now that will enact immediately following DEA. There are a handful of states that will do it within 30 days. We have an active presence in the states that have undetermined time frames on their legislative books or regulatory framework. We're working in those states to pass legislation to bring that forward.
Got it. Okay. I want to go back to a topic around kind of the number of sites that are being activated for the use of SPRAVATO. I think, Lori, you mentioned that 80% of the volume comes from about 1,000 sites. Can you talk about how is Compass thinking about prioritizing which sites to focus on, and how are you going about making sure that sort of the physicians and the practitioners in those sites are appropriately trained, and you're also getting kind of that pull-through of demand from patients?
One thing that maybe is more from kind of a patient perspective related question, do you think that this is going to be a case where the physician offers an alternative treatment to the patients, or is this going to be more of a pull where the patient comes in and says that, "Yeah, I've either been taking SPRAVATO or ketamine, but now I've heard about this new treatment, which requires me to come in less frequently. How about I try that?" How do you see that dynamic work through? Maybe there are two questions in here.
Maybe, Steve, you want to talk about the strategic collaborations, how we're getting things ready. We'll all give you an answer to the second one, both.
Yeah. That's an easy one. We'll knock that one off quickly.
Yeah.
Yeah, that sounds good. Right. First, a major way that we've been going about this, as Kabir just said, is through the network we've built of strategic collaborations. These are live commercial sites that are caring for patients with treatment-resistant depression today. They include a few networks of interventional psychiatry clinics, the ones that are high-volume prescribers today of SPRAVATO. It's not exclusive to those, because we are also interested in what it will take to activate and get implementation into other types of sites of care as well, recognizing that the interventional clinics, the ones that are already set up to deliver multi-hour treatments, are likely to be the earliest adopters, particularly in the period of time closest to launch. We're also looking beyond that time because we are ultimately interested in broad and equitable access.
That's why our collaboration network also includes community behavioral health, hospital systems, integrated delivery networks, decentralized models that are more innovative in how they set up their infrastructure, et cetera. From that, first of all, within those included in our strategic collaboration network, it already represents a healthy percentage of the high-prescribing SPRAVATO sites. Beyond that, through other relationships or through the work of our field medical team, we've also been interacting with the other high-volume sites and others that are experienced in delivering SPRAVATO for multiple years now. Through that, we believe that we understand their patient flows, the patient journey, the staffing, the workflows, how they've been trained to date, how they implement new trainings if and when they're necessary.
We feel fairly confident that we are very much on top of making sure that they are ready at the earliest possible date. Even if we weren't motivated to do so, they'd be bugging us because they're feeling the pressure of their current patients, who, as they tell us, are forming a line around the corner already, because they are aware of this treatment coming and are highly motivated. With the other sites, it's deep information exchange, really understanding if they've implemented SPRAVATO to date, what their experience has been. If they've not, why not? What have been some of the barriers, and what kind of support would they need? This, again, helps us to understand, for the longer period of time post-launch, how we get broader uptake of this treatment.
Okay. All right.
Lori, perhaps you want to give a slightly fuller answer to the second part of the question.
Yeah, I can expand a little bit more on our very quick response to both, also adding on to a little bit of what Steve just said. We will focus on, obviously, the high-prescribing sites when the sales force is out en masse. That's what we call low-hanging fruit, right? They're already set up. They're already high-prescribing SPRAVATO sites. They have patient flow in there. There is also a very large portion of sites, again, that I mentioned very early on, that they're set up for these multi-hour treatments and very easily could adopt COMP360. These sites, based on what we know through either the strategic collaborations or our field medical work, are preparing for the psychedelics that are coming to market, COMP360 obviously being one of those.
They are getting their infrastructure set up so that they can support these treatments once they come to market. It's important to remember that there are four million treatment-resistant depression patients out there that could easily be covered from a payer reimbursement standpoint if they were to be sent and offered a treatment that is indicated for treatment-resistant depression. Right now, SPRAVATO treats less than 100,000 of those patients, and still on a very fast and high trajectory of a runway of both revenue as well as additional prescribers, additional sites, additional patients being added year-over-year. There's a lot of room. The reason more patients aren't treated for treatment-resistant depression is because there aren't great options. There is literally only SPRAVATO from a pharmacologic standpoint out there, and it is highly burdensome for a patient.
This is a big consideration for a patient to say, "Yes, I'm going to commit to three to four hours of my life every week for the first month, or twice a week for the first month, every week thereafter," is a very large commitment, not only for the patient, but also for their caregiver. We believe that even though SPRAVATO is doing fantastic at really developing the market, making sure there's awareness around treatment-resistant depression, that the limited uptake, in terms of patients treated, is because there haven't been great options from a patient burden standpoint. In terms of patients that we will get at launch, yes, we will probably get some SPRAVATO patients, but that's not our easy target, nor will it be our early target. If a patient, especially a treatment-resistant depression patient, is stable on SPRAVATO, we are not fighting for that patient.
We want them to stay as stable as possible. Undoubtedly, there will be some who say, "Yeah, this is kind of burdensome for me. I would like to try COMP360." Fortunately, with the profile that we are generating, with knowing very quickly if this product works, and it's also safe and tolerable, could be an easy option for patients to try. There's also patients that are sitting out there, that gap, that 3.9 million, that are sitting there ready to be treated with treatment-resistant depression. We'll see that influx start to come in. There's also a whole bunch of patients who have just dropped out of being treated because there's nothing that's worked for them. That will also come into the funnel.
Mm-hmm. Yeah. I think maybe a broader question that I think we get from investors is the capacity for so many more patients to be treated, and in one sense, it's obvious that, look, there are four million TRD patients, and SPRAVATO's barely touched the tip of the iceberg in terms of how many patients are being treated today. Is there a bottleneck that isn't obvious to us, or is it just about blocking and tackling education and kind of building out, expanding the number of clinics? Is there sort of an operational hurdle in terms of being able to have enough number of rooms to be able to treat more patients? How are you thinking about that question, and maybe what are we missing when we ask this question?
Maybe, Steve, you want to start with that?
Yeah, I could start. While we expect to continue to see capacity expand, given the pace of building of new interventional sites that Lori mentioned earlier, there is significant capacity already in the existing built infrastructure.
Mm-hmm.
Whether it's the statistic that Lori mentioned earlier about the bulk of SPRAVATO prescriptions coming within about 1,000 of those 7,000+ sites, even within some of the high-volume prescribing SPRAVATO centers themselves, there is capacity. First of all, there's no such thing as any kind of healthcare services organization operating at 100% capacity anyway. Typically, 80% is considered excellent. Most of these centers have a capacity utilization well below that. What they also tell us is that if there is the good problem that they do fill their existing capacity, they will be happy to expand the size of their clinics or to build new space. Because frankly, and I never like to talk about people living with treatment-resistant depression in sort of a cold, financial way, the reality is that these are relatively low-cost patients to acquire.
They have a high lifetime value, given that this is a chronic illness, and they often will receive multiple treatments over the course of their illness. Within an interventional psychiatry clinic, over time, they may receive any or all of the treatments that are available. The cost to build these spaces, either expanding them or building them de novo, is actually quite low. Certainly relative to other fields of medicine where it can be expensive to build offices, this is quite cheap. From an economic standpoint, it is a very easy decision for them to build if they need additional capacity.
Okay.
I think perhaps the key here is, Ami, that it's not a physical infrastructure bottleneck that is dictating that small percent who's treated. It's the lack of really optimal options from a patient perspective, not so much from the results necessarily, because we acknowledge SPRAVATO, TMS can produce good results. The patient burden and the logistics of actually having those sorts of highly intensive multiple repeated treatments, that, in our view, is the single biggest barrier to that penetration. The fact there needs to be more education of psychiatrists to really refer, and again, that's a bit of a chicken and egg. Until there are more options, that referral will not build. We actually see that as a virtuous circle that we'll start to see that with more options, of which COMP360 being the next one.
Okay, I know we are coming up to the end of our time, but I wanted to touch upon the hospital setting and the IDN setting. I think we often talk about this class of treatments in the context of clinics. Maybe help us understand how many patients show up at a hospital with maybe a suicidal attempt or with sort of depression and, a couple of years out, I'm not asking for a specific percentage, but do you see the hospital and the IDN setting being a substantial portion of where these patients end up getting treatment? Maybe kind of talk about the demand at that point.
Yeah. Maybe Steve first, then Lori?
Yeah. First, these are settings of care where many patients with treatment-resistant depression receive their care. I don't know that that type of setting, an IDN, a hospital system, will ever necessarily on its own be a high-volume prescriber. There are many of them. In the aggregate, that represents access for many more patients than may be served today. That really is the primary driver of understanding what it will take to have access in those sites, because it allows potentially for much broader access for patients to receive care where they're already receiving their care. Whether that is hospitals, IDNs, or even small to medium-sized practices, there is an effort right now amongst organizations that provide management services to take on some of the back-end burden of the complexity of delivering treatments like this.
There have been some announcements recently about partnerships in that direction. That's something that we are watching, and we have relationships with these organizations as well. Again, I think that that is something that's a little bit longer-term. In terms of the targeting in the initial period post-launch, as Lori said, there's the low-hanging fruit of where we know sites already have the capacity to treat patients at scale.
The only thing I'll add is that's part of the beauty of this network of strategic collaborations that Steve has spearheaded working with, is that we're not only focusing on immediately what we're going to do at launch, but really with the vision of how we enable broad and equitable access in the long run.
Okay. I know we are coming up to the end of our time, so I wanted to thank you all for taking the time and for this interesting discussion. We are obviously all going to watch the first psychedelic launch, and so I wish you all the best.
Thanks so much, Ami. Thanks for inviting us. It's been a pleasure.
Thank you.
Likewise. Thank you.