Unidentified Analyst: Hi, this is [indiscernible] from Cantor. Great to hear all the progress made in 3Q, two questions for us. Can you talk about the progress of KarXT study in psychosis and Alzheimer’s? And what are, if any, the rate limiting factors for patient enrollment? And the second question is for KarXT for schizophrenia. What are your expectations for an ADCOM? And what are possible key topics for that discussion? Thank you for taking our questions.
Bill Meury : Great. Thank you. Good questions, Andrew.
Andrew Miller : Yeah. With respect to the ADEPT program, obviously, the ADEPT-1 study has been ongoing since the second half of 2022. ADEPT-2 just started more recently here in the third quarter. So those studies add slightly different points from an operational perspective, certainly in ADEPT 1, but also in ADEPT-2 focus on finding recruiting the right patients into that study. I think in any study in psychiatry, finding patients who sort of really fit the key inclusion criteria with respect to diagnosis and severity as well as general health tend to be the sort of limiting factors. That’s all built into our assumptions around a number of sites and duration of time needed to successfully for those studies. So nothing specifically that I would point to you for the ADEPT program outside of sort of more general considerations.
With respect to an ADCOM, we certainly have already begun our preparation process for a potential ADCOM. I think our views were less likely than 50% to receive an ADCOM. That’s really on the basis of having a clinical program for an indication treatment of schizophrenia adults that’s well precedented from a clinical trial design and endpoint and general methodology perspective. Our development program follows those precedents over the last several decades. But of course, that’s up to the FDA discretion whether they’d like to add an ADCOM and what the topic of that would be. But it’s certainly something that we’re already getting ready for and we’ll certainly be ready for if an ADCOM does happen.
Operator: Our final question comes from the line of Graig Suvannavejh with Mizuho.
Unidentified Analyst: Hi, this is [indiscernible] for Graig Suvannavejh. So just two questions from us. In terms of the Day 120 update, can you elaborate a little bit more specifically regarding who will be part of the update besides the ABPM data. And additionally, with the potential KarXT launch next year, how are preparations for FDA manufacturing inspections going. Thank you.
Andrew Miller : Yeah. So with respect to the day 120 safety update, really, the bulk of that information is simply a 120-day roll forward in all the patients that are currently ongoing in the immersion program. So typically, for the NDA and day 120 safety update, there’s simply a date on the calendar by which all data that’s been collected prior to that date is included in the submission. So we’ll have a four-month roll forward of that safety data set as part of the program. This is less about completing studies or specific data, but more a general roll forward of that database. With respect to manufacturing, inspection readiness, et cetera, I think in general, from a CMC perspective, we feel, I think, in a very good place from a submission perspective, from a potential inspection as well as supporting the launch, we’ve been manufacturing KarXT at multi-hundred kilogram scale commercial sale for quite some period of time.
We already have millions of capsules that are currently dispositioned and ready for a potential sale, assuming that we get approval. We use manufacturing sites that are known to the agency have been expected previously by the agency. And so we felt quite confident going forward that we have a CMC manufacturing strategy to support the potential approval as well as the launch.
Bill Meury : Thanks, Andrew. Thank you for the question.
Operator: Thank you. This does conclude today’s call. Thank you for joining. You may now disconnect your lines.
