Kabir Nath: So I think we’ve always been clear to say that we regard digital at the time of launch as tools that potentially are a benefit to both patients and therapists. While we’re doing some very interesting work around understanding some of the markets understanding as Guy described just now, how we can actually link what happened in sessions between the therapists and the patients to outcomes. Our expectation is not that, that will be in place for launch. We clearly need to do a lot more work about building robust data sets and validating those. So what we’re looking at a launch is digital tools, if you like, and at my pathfinder, therapist companion as well. I think, clearly, digital therapeutics per se has been a pretty challenging field in mental health, and we haven’t really seen any one established scale there yet.
But our ambition is to help get patients with serious mental illness to better outcomes. And yes, I can see down the road that could be the potential for synergies or working with some of these other companies that have made progress in that. But right now, that’s not a core focus or a core priority for us.
Patrick Trucchio: There’s a number of these investigator-initiated studies that are ongoing across several indications. I’m wondering if you can give us an idea of which of these studies might complete this year or next and which do you think could provide helpful insights occur in our future programs?
Dr. Guy Goodwin: Yes, I’ll take that, Patrick. I mean, we have one which is — I think will be published next year, which was in TRD in patients primarily drawn from the VA system to have a lot of prehearing trauma and an interesting study. We also have another one which looks at utility rather specifically. And I think that will probably have some preliminary data certainly in 2024. I think in addition, we’ve already — I think you made you aware of the anorexia study in Imperial, but that will probably be fully published later in 2024. So I think those 3 examples are probably the best. And I mean we can’t be entirely predict some of the others that are — as you know, we can’t predict any of them properly because they’re not our studies.
But we know that the three I have mentioned will be reporting in some detail. And of course, they’re rather relevant, particularly the TRD and the finality studies that they’re rather relevant to our core focus. So we’ll be very interested in those.
Operator: Our next question comes from Jason McCarthy with Maxim Group.
Michael Okunewitch: I guess to kick off, I’d just like to see if you could expand a little bit on Francois’ question regarding the AI model. Given that this is something of an early response analysis rather than a predictive marker, Will you look at whether this could be part of the decision process or whether a patient would go into only needing one dose or potentially a repeat dose like you’re evaluating in the 006 study?
Kabir Nath: At the moment, we’re thinking of it more in relation to the quality of the therapy input and how we can feed back to therapists how they’re doing. There is this predictive component very early on, but we’re not clear that, that is more predictive than the very early change in symptoms that we also see. That’s why I want to be clear that it’s not fully predictive in the sense that we don’t know that patients are responding by other measures. So I think the question is how far it can be automated, how far it’s acceptable to actually record patients and therapists outside an experimental setting. So I think we’re cautious about how it’s likely to be practical to apply it. But we do think that it can improve our understanding.
It supports our clinical measures because it’s clearly not administered by someone. It purely arises from natural ecologically sound interactions. And it also, as I say, may help us in the way in which we refine the therapist training, which will be very key to how we launch the COM 360.
Michael Okunewitch: And I’d just like to see if you could comment on if there’s anything that you’re specifically looking at or evaluating from the MAPS regulatory process and launch prep to possibly help inform your strategic direction for COM360?
