Herriot Tabuteau: I’m sorry, Marc. Oh my god, all these sell-side analysts who are starting with Lori to won. No, of course not. All of you are very distinct. So Marc, with regards to the interactions with FDA, we saw feedback on the trials. The feedback that we got from the agency is that in the elderly patient population, safety is really important, not just long-term safety data, but also the theme of referral (ph) safety data. So the ACCORD trial, it was a randomized withdrawal study. So it does not provide the randomized safety data, which is really important in this patient population. And the other aspect of the study with the FDA did highlight, not necessarily show-stopper, is the fact that this was truncated study.
So — and importantly though, the feedback with regards to exact patient numbers for the safety database is that it must meet ICH E1 guidelines. So what’s good is we’re in a good position to provide actually all of those data points to the NDA. We do have the ADVANCE-1 trial, which is already ongoing, which is enrolling. And so — I’m sorry, the ADVANCE-2 trial, which is already enrolling. And so we’re in a good position to provide all the safety data which would be required for the NDA filing.
Marc Goodman: Herriot, if ADVANCE-2 fails from an efficacy standpoint then what?
Herriot Tabuteau: Well, that would be speculation. But we are encouraged that we currently have two positive trials in this indication.
Marc Goodman: Right. That’s my question, did the FDA agree that you have two positive trials?
Herriot Tabuteau: The FDA never agrees to anything until you file an NDA and they review it. But it’s very clear that we do have two positive trials. We are very encouraged by that. And we’re on track to provide the safety information that will be needed for an NDA filing.
Marc Goodman: Okay. And then the gross to nets for both products for this year, how do we think about that?
Nick Pizzie: Yeah. Sure. Hey, Marc. It’s Nick. For gross to net sales for the quarter for Auvelity, I’ll start with, gross net for the quarter was in the 60s. As of right now, we’re not currently in a position to give specific guidance around GTN. However, we remind you that there’s no reason to expect that’s actually going to improve from this quarter and then obviously, could potentially worsen based on Q1 being typical — the seasonality that you expect a typical headwinds of planned coverages resetting in year, inclusive of deductibles, co-insurance, PAs would need to be in some plans would need to be recreated again. So potential utilization, higher utilization of the co-pay card. And then obviously, mix and channel distribution always impacts GTN.
So we would expect in Q1 and Q2 that we wouldn’t expect anything better than where we were at today and potentially it could worsen. Specifically around Sunosi. Sunosi, we were in the low 50s. Again, for this quarter, we did have a favorable adjustment from the prior quarters of $1.8 million. The GTN adjustment as we received updated claims, which is typical that we received them in this quarter. Otherwise, for Sunosi, it’s pretty much been stable in the low 50s.
Marc Goodman: Thank you.
Nick Pizzie: You’re welcome.
Operator: Our next question is from the line of Vikram Purohit with Morgan Stanley. Please proceed with your questions.
Vikram Purohit: Hey. Good morning. Thanks for taking our questions. So we had two on Auvelity. So first, just wondering if you could provide some color on kind of the typical profile of patients that are currently receiving Auvelity in terms of the prior treatment history and the lines of therapy that have been on prior to being prescribed Auvelity? And then secondly, I just wanted to see if you could provide an update on ex-U.S. commercialization and partnership discussions if those have been happening. And if so, what you’d be looking for in a potential partner for AXS-05 ex-U.S.? Thanks.
