François Brisebois: Okay. And I’m just wondering, any thoughts on the implication of the generic doing well for your product?
John Bencich: Yeah. I think, we obviously €“ it helps solidify the size of the market that we’re going into. So I think seeing a generic out there selling a healthy amount of scripts, I think does provide a nice tailwind, again, given the differentiation that we see with cytisinicline being €“ having single-digit rates of adverse events strong efficacy as well as a shorter course of treatment option. I think it bodes well that, it will resonate well in what continues to be a very robust market. One of the things that we are €“ we will also continue to monitor for is further generics entering. But so far it looks to be only Endo that’s available today.
François Brisebois: Understood. And then in terms of the e-cigarette here the V1 trial, is there any chance, maybe compare and contrast the study designs between ORCA and the V1 €“ ORCA-V1? And any reasons that e-cigarette cessation wouldn’t any cell sickling wouldn’t work as well for this type of nicotine addiction?
John Bencich: Yeah. So if we just think about the mechanism of action for cytisinicline, it’s specifically targeting the nicotine receptors in the brain. And so, we think it should have applicability on a broad basis for various forms of nicotine addiction. The data we’ve seen historically has all been focused on cigarette cessation. So we’ve got a high degree of confidence that works there. But it should have applicability, whether it’s vaping, chewing tobacco, snooze, any form of nicotine addiction. But we haven’t tried it there. So we’ve got to run the experiment and see if we can again show that efficacy in this new segment. And this is from a market perspective, the category that we’re most excited about. I think when you look at 30 plus million e-cigarette or cigarette users here in the US.
The e-cigarette market is the next largest segment behind it with more than11 million users. So we think it’s the right place to be. We see that as a segment that will only grow over time as big tobacco continues to redirect their marketing dollars there. And as we mentioned on the call today, seeing more and more data points coming out around the harms associated with e-cigarettes, we do see more and more folks in this category looking for solutions to help them quit, and we think we can be a viable solution there.
François Brisebois: All right. Thanks, John, and congrats on the progress.
John Bencich: Yes, thanks, Frank.
Operator: And our next question comes from Michael Higgins from Ladenburg Thalmann. Go ahead, Michael.
Michael Higgins: Thanks, John for taking the questions, and congrats from me as well on ORCA-V1’s enrollment and the progress in your development efforts. A couple of questions on the Sopharma construction of the API suite. Just trying to understand, what are the next steps going forward here into gaining FDA approval of that supply and then the obligations that they additionally may have to you guys.
John Bencich: Yes. Thanks, Michael. So the API suite, we see as a nice milestone just in terms of our partnership with Sopharma and getting a dedicated facility specifically for our product. And I think having that in the same location is their tableting facility in Sofia, which is a less than 10-year-old facility really is state-of-the-art computer-controlled I think, puts their best foot forward as we think about moving this forward to an NDA submission. So I think there will be a lot of efforts as we move ahead to an NDA filing, continuing to work with Sopharma to make sure that they are ready for an FDA inspection. And so that is a high area of focus for us as we drive things forward in parallel in the clinic with ORCA-3 data coming together in the second quarter of next year.
Michael Higgins: Just to follow-up with that, are you able to share with us when the FDA may be coming in to take a look at that facility?
