Operator: Thank you. One moment for our next question. And the next question is from François Brisebois and the company is Oppenheimer. Your line is open.
François Brisebois: Hey, guys. Thanks for taking the questions. I was just wondering you touched on after Mike’s comments Kabir, you touched on the CPT code and — at launch and reimbursement. I was just wondering if you can add color to that because I do think it’s a very important part of the story here?
Kabir Nath: Sure. Happy to. So we recognize from the get-go that the psilocybin administration session of kind of six to eight hours is essentially unprecedented. And learning also from some of what happened with Spravato around the fact that it launched from a monitoring perspective Janssen hadn’t necessarily put a comprehensive strategy towards this in place. We recognize that we actually needed to put in place a code that could potentially cover that extended administration. So the team has actually been working now for a significant period of time with the necessary professional associations both APAs, essentially both psychiatrists and psychologists and other groups made a submission to the AMA. We’ve now had two meetings and I think the latest meeting in February we’re very confident that we will get that tracking code.
Now initially clearly, this will be a tracking code, but once it’s issued even during the conduct of the trials, we’ll be able to use that to start to understand what actually the allocation of work by whom is to supporting those administration sessions. And that will allow us to build the body of evidence to turn that into a reimbursable commercial code soon after launch — at launch or soon after. But as I said, learning from the previous experience, we recognize it was essential to have that new code in place as soon as possible. And we’re confident, as I say that, that should be in the next couple of months.
François Brisebois: Okay. And is that code related to purely the administration, or you mentioned the word support. Is there any psychological support that could be encompassed in that €“ intended in that code?
Kabir Nath: Yeah. So our view is that, existing codes can cover the preparation and integration sessions which are shorter. This is for the administration session. And as you know, we define what we offer is a metapsychology support not as therapy, because it’s not directed, it’s not interventional. It really is there to support the patient through the experience, but it needs to be provided by trained professionals and the code is designed to cover their services in that.
François Brisebois: Okay. Great. And just lastly on that, because it’s a new field and there’s a lot of unknowns here. Just to be clear, can you just talk about maybe the learning’s in the past year, two years of looking at this in terms of the difference between psychological support and psychotherapy? And how has that evolved in terms of your thinking of the approach?
Kabir Nath: So €“ and this is a topic, which we could dive into much longer. I think from our perspective from the COMPASS perspective, right from the start, we have seen this as psychological support. There are things that we think are absolutely critical. Clearly, preparation, it’s critical, ensuring the right expectations for the patient, particularly acknowledging we’re in a clinical trial setting where there are a variety of treatments may be possible and so on. But we have always been clear that, during the administration of psilocybin itself, this is around support rather than directed therapy. I’m very conscious of the fact that, there is a very wide range of opinions across the community. But I think from COMPASS view we’ve always been clear to use the word psychological support, as opposed to psychedelic-assisted therapy and that is where our mind is.
François Brisebois: Great. Thank you and see you guys next quarter.
Kabir Nath: Thanks, François.
Operator: Thank you. One moment for our next question. And our next question is from Patrick Trucchio with H.C. Wainwright. Your line is open.
Patrick Trucchio: Thanks. Good morning. Just a clarification on the protocol changes to the Phase 3 TRD program. I’m wondering, if you would also need the long-term outcomes component to submit an NDA for TRD, or would you be able to do that following the top line readouts from the 005 and 006 trials?
Kabir Nath: It’s a great question. And clearly, as we start the Phase 3, it’s a little premature to know what our regulatory strategy would be. We clearly see the primary endpoints still at six weeks of 005 and 006. What I will point out is that, by the time we get to that primary endpoint for 006, we would actually have the entirety of 005 in hand, the full 52 weeks. And I think, we will see that as a pretty robust dataset from a regulatory perspective. But more than that, I think it’s premature to speculate on what exactly the dialogue with the agency would be. And of course, it’s data-driven.
Patrick Trucchio: Yeah. That’s helpful. And I’m wondering, if you can discuss whether you would intend to move ahead with a Phase 2 trial in COM360 in bipolar depression. And then I have a follow-up on that.
Kabir Nath: Thank you. So we are €“ like I said, I mean, the results are amazing, but it is just 14 patients and 12 out of 14 open-label single site. So we recognize that in order to really validate that we’d have to. We are thinking around what a design would look like what sort of control arm you would need for bipolar what sort of size, but that thinking is right now and it’s relatively early stages.
Patrick Trucchio: Got it. Okay. That’s helpful. And then, I guess, maybe just a separate question. Just around — there’s multiple programs, of course, advancing with short-acting or short-acting mechanism of action with psychedelic agents. There’s also some of the longer-acting compounds that are advancing clinical development. And so I’m wondering, as the space kind of builds out how — if you can discuss the advantages of COM360 compared to some of those other approaches including compounds like DMT or 5-MeO-DMT. And how would you expect these advantages of COMP360 to be demonstrated in the Phase 3 program and some of these other trials that are now underway.
Kabir Nath: It’s a good question. And I think without — so I mean my fundamental response is data is what will determine where those agents are best used and so on. So like everyone, we’re intrigued by some of the data that’s emerging from shorter-acting, but until it’s been validated in much larger studies and in particular some of these questions around durability that we’re attempting to answer in Phase 3 are answered by other molecules, other mechanisms it’s kind of too early to say how the field will shake out. But I think what we’d also say is they are very different experiences from a patient perspective. And while there is obviously a school of thought that says by definition shorter-acting has a — shall we say an easier route into commercialization.
I think it’s way premature before we’ve seen data before we understand the experience that patients have and so to know whether in fact duration alone is a kind of key to differentiation. So obviously we continue to watch the space and I’m pleased that other agents are moving forward with good data. I think that’s fantastic for the field and for patients. But I think we’re a long way from determining what the competitive set ultimately looks like from a patient perspective and a results perspective.
Patrick Trucchio: Okay. That’s helpful. Thank you very much.
Steven Schultz: Thanks, Patrick.
Operator: Thank you. One moment for our next question. And our next question is from Elemer Piros with EF Hutton Group. Your line is open.
Elemer Piros: Yes. Good morning. Thank you for taking my question, Kabir. What I’d like to — if you could clarify please that would there be a retreatment paradigm in Port B both in the 005 and the 006 trials?
Kabir Nath: Yes. So as we said earlier for those who do not respond who after remission relapse there is the option for retreatment in Part B. Clearly, it’s the patient’s choice remembering that it will be in their original assigned treatment.
Elemer Piros: So it is true. So retreatment will occur even in the 005 trial?
Kabir Nath: So retreatment either with 25-milligram or placebo at patient choice yes.
Elemer Piros: Okay. And I think you just clarified, but I just want to make sure that I understand that even those who are not responding well would have the option to be retreated.
Kabir Nath: Correct.
