Tim Lugo: Thanks for taking the question. For the launch, are you going to set up a central hub to deal with any preauthorization or access hurdles physicians may have to deal with kind of during the early part of the launch?
Barry Greene: Yes, Tim, thanks for the question. Look, we’ll — we have a very — we imagine a very robust channel strategy in place that deals with everything from — to the extent there’s prior author steps to make sure that if the script is written, that patient gets the drug. So look, that will all be set up and in place.
Tim Lugo: Okay, great.
Barry Greene: Thanks, Tim.
Operator: We’ll move next to Neena Bitritto-Garg from Citi.
Neena Bitritto-Garg: Hey, guys. Thanks for taking my question. I actually just had a question on the KINETIC 2 study. I was just wondering if you could give us an update on what you’re seeing on the enrollment front there? And if some of the measures you took to speed up enrollment have resulted in a faster pace? Thanks.
Barry Greene: Thanks, Neena, for the question. Jim, do you want to take that?
Jim Doherty: Yes, of course. Thanks, Neena. As you mentioned, we’re currently very focused on completing the KINETIC 2 Phase 2b study for central tremor in the Phase 3, Q4 program. The KINETIC 2 study is currently opened for enrollment and we’re anticipating completion of enrollment in late 2023. As I’ve spoken about previously, a number of factors have challenged the KINETIC 2 study, one of those was clearly some staffing challenges at sites and CROs coming out of pandemic, that’s something that’s being seen across the industry. We also saw a little bit of a slower pace in enrollment than we had originally anticipated, due to some specific criteria in protocol. And finally, there are multiple ET trials that are targeting a similar patient population that are going right now.
But we — as we mentioned previously, we made some modifications to the program and we’re confident that those modifications are having a positive impact. So as I say, we expect to complete enrollment in late 2023.
Operator: Douglas Tsao from H. C. Wainwright. Please go ahead.
Douglas Tsao: Hi, good morning. Thanks for taking questions. Just curious, how do you plan or do you plan on doing a post marketing study? And I’m just curious, in order to understand how frequently patients need to be treated with Zuranolone. Obviously, just given the fact that patients switch payers a lot and so forth and obviously there are sort of limitations with like IQVIA and so forth data. Just curious how do you over the long-term plan to understand the profile and how frequently patients need to be treated? Thank you.
Barry Greene: Yes. Thanks, Doug. That’s an important question. So what we know today and as Jim commented on this earlier is, SHORELINE is the largest naturalistic study impression on , and the data are pretty clear. Now, while SHORELINE isn’t exactly real world as close to real world as we get this point. And what we see for SHORELINE is for those that respond to the majority required only the initial two-week course of treatment, and then if the number is 80% required out of one or two course of treatment in calendar year. So we believe that that’s how it can pay out real world. Now once Zuranolone is approved, we’ll certainly work a number of different ways to understand what’s happening over time, whether it’s registries, or payer collaborations, we’ll have those data at hand.
And of course, because we have — we will have value-based agreements in place. Those will be informative as well, so there’ll be a number of sources for us to understand how many two-week courses a population needs over a period of time.
Douglas Tsao: Physicians, do you get a sense of they’re going to use Zuranolone initially as an add on? Or do they want to use it as a monotherapy as sort of a switch?
