John Bencich: Yes. So those three are obviously critical in terms of having those key components that we knew were going to be needed for the NDA. I think as we finalize the pre-NDA discussions, we get those file written minutes, we’ll be able to clarify further timing on the NDA piece. And I think the key piece of this is getting clarity going forward and that feeds back into the partnering discussions and making sure that the path towards approval is fully clarified, and that’s exactly what we’re getting out of the pre-NDA meeting. Makes sense. Appreciate it. Thanks, guys.
John Bencich: Thank you.
Operator: Our next question is from the line of Francois Bridge with Oppenheimer. Please proceed with your questions.
Unidentified Analyst: Hi. This is Dan on for Frank. Thanks for taking my questions. Firstly, congrats on JAMA publication, also the ORCA-V2 presentation at the V1 presentation at the SRNT. Can you give us a sense of the KOL feedback that you’re hearing from these conferences? Anything in particular in terms of cytisinicline features, tolerability, efficacy that is standing out, that is coming up? Any color there?
John Bencich: Yes. Thanks for the question. I’m going to hand this over to Cindy.
Cindy Jacobs: Yes. Well, Nancy Rigatti actually presenting and our other KOLs are pretty excited as far as the efficacy that cytisinicline shows but actually, there are even more impressed and excited about the safety profile, which allows them individuals to stay on treatment and get the benefit. So it’s really a combination of the efficacy and safety profile that they are the most excited for smokers and in the future of vapors to actually have a new therapy to help their nicotine dependence.
Unidentified Analyst: Great. And just any updates on the FDA inspection readiness on the – Sopharma front? And also any updates regarding preparations with regard to supply chain, getting the registration batch are all those processes on track?
John Bencich: Yes. Thanks for the question there. So I think the Sopharma and CMC attributes are going to continue to be focus as we move forward through NDA submission. As we’ve indicated historically, we’ve been working very closely with Sopharma and their readiness efforts including numerous mock FDA inspection audit. So that work will continue. As we progress and Sopharma continues to be confident that they can be ready for a future inspection. But it will continue to be a high area of focus for us as we proceed.
Unidentified Analyst: Thank you. Thanks for taking my questions.
Operator: [Operator Instructions] The next question is from the line of John Vandermosten with Saks. Please proceed with your questions.
John Vandermosten: All right. Thank you. Is there any reason to think that the potential vaping Phase 3 trial would be much different from ORCA-3. Are there any considerations there? Might it be smaller or I know it’s kind of early, but just thinking ahead on that.
John Bencich: Yes. So in terms of overall sizing, I think looking back at ORCA-2 and ORCA-3 is probably a good proxy in terms of overall sample size. As we’ve indicated before, our belief is a single Phase 3 trial is what would be required for approval in this indication. But ultimately, we’ll need to get guidance from FDA on that. But the ultimate design, we’ll still be working on in terms of what that looks like. But yes, that sort of size is what you should anticipate.
John Vandermosten: Okay. Great. And I was doing some reading on varenicline and there’s thoughts that it could be used for other types of addiction, perhaps cocaine and things like that. Is that something that you might consider as well to pursue beyond nicotine addiction.
