Barry Greene: So we — in the scientific exchange that we have with potential prescribers and our investigators, we’re hearing different views. And the good news is that we have data with Zuranolone as a monotherapy, on top of a stable antidepressant and co-administer with antidepressant. So we have a around Zuranolone to use the medicine as the patient feels appropriate for — as a physician feels appropriate for their patient. We’ve heard some physicians for certain patients such as young adults, they might want to use the monotherapy for someone that frequently suffers from the depressive episodes, they want to prescribe it as a co-administration. So we have the optionality and the data to support the way a healthcare provider can set to treat their patients.
Douglas Tsao: Great. Thank you very much.
Operator: We’ll move next to Marc Goodman from SVB Securities.
Rudy Li: Thanks for taking my question. This is Rudy on the line for Mark. I have two questions for SAGE-718. So the LIGHTWAVE and DIMENSION study using the initially higher dose followed by lower dose? Well, the other two study uses fixed dose as 1.2 milligram. You can talk about the rationale for the dosing selection? And secondly, can you talk about the difference between patients that using inpatient versus outpatient settings? Thanks.
Barry Greene: Yes, Rudy, thanks for the question. Look, we’re really excited by SAGE-718 as the first-in-class NMDA PAM that we’re studying for cognitive impairment across neurodegenerative diseases, including Huntington’s, Parkinson’s and Alzheimer’s. The program is progressing very well and we’re really excited to have data from that program in 2024. In terms of your specifics, Jim, do you want to talk about this dose in, in and out patient?
Jim Doherty: Absolutely, Barry. And as Barry said, we’re very excited about 718 here. We’re currently running five Phase 2 studies across three different indications. Huntington’s disease, Parkinson’s disease and Alzheimer’s disease. And really the dosing that you’re referring to where — what the strategy is to achieve and maintain a certain level of exposure for SAGE-718. And so what you’re seeing is as the program matures, we are doing that. So the goal is in the case of the DIMENSION study, which is dosing for over a three-month period to achieve and maintain that dosing level. We are at this point looking at outpatient studies for the SAGE-718 program, the profile of SAGE-718 both from a safety NPK perspective really allows them to do that. So all these studies are outpatient studies.
Barry Greene: Yes, I would just add in, Rudy, that the benefit risk we’re seeing for SAGE-718 is extremely broad. We’re seeing rapid improvement in higher order cognition, executive function learning and memory and it’s incredibly clean . So we’re really excited about continuing to move that forward.
Rudy Li: Got it. That’s very helpful. Thanks.
Barry Greene: Thanks, Rudy.
Operator: Gary Nachman from BMO Capital Markets. Your line is open.
Gary Nachman: Hi, good morning. With the priority review for Zuranolone, do you still think there’s a possibility for an AdCom, does that change at all with priority review timeline? And where would you find that out? And then the way the NDA has been filed, you’re obviously looking for an approval in both MDD and PPD together. But is it possible for the FDA to split those up and approve one indication first, and then the other at a later point if that ultimately wants to see more data? Thanks.
