John Bencich: Yes. In terms of timing, it will be unlikely that the FDA makes any business until after an NDA is on file. So we’re still more than a year out from an anticipated NDA filing date. So between now and then, again, we’ll continue to be working with Sopharma to make sure they’re prepared for a future inspection.
Michael Higgins: Makes sense. Turning to ORCA-V1. What can you share with us and you may not be able to, but if you could share with us any make-ups of the patients that have been enrolled, such as how many are dual users age, duration of smoking, that sort of thing. Thanks.
John Bencich: I think for this one, I’ll hand this over to Dr. Jacobs again.
Cindy Jacobs: Sure. For the study, no one could be dual users. That’s just too complicated. So the subjects in the vaping study were vaping nicotine only. And the demographics is we’re seeing a younger crowd, obviously, where they’re in their 20s and 30s versus the smoking cessation, most were in their 40s, 50s and 60s. So it will be a younger population in this study.
Michael Higgins: Do you know if the — thanks Cindy. Do you know if the patient or receiving any text messages or anything unique about the, what’s called standardized behavioral support? Thanks.
Cindy Jacobs: Yes. Standard, there is no really standard behavioral support for vaping cessation. So we basically took a lot of the materials for smoking and applied it then in a vaping cessation. We did this with our PI, Dr. Nancy Rigotti and our key opinion leaders in the area. So the study does have standardized vaping cessation material. There was no like elaborate text messaging for that. We obviously have texting as far as taking meds on three times a day, that’s part of the study. But everyone has the same counseling for stopping nicotine dependence. Basically, we’re focusing on that when they come into the clinics every week as well.
Michael Higgins: That’s helpful. And then, one last one. Maybe you can help with here is the Q1 we’re looking for renally impaired patient trial to finish up in the Phase I QTc study. Still on track for those?
Cindy Jacobs: We’re just — we’ll be initiating those by the end of this year. And so, they will be completed sometime early to mid next year.
Michael Higgins: Sounds great. Appreciate it. Thanks, guys.
John Bencich: Thanks, Michael.
Operator: And our next question comes from John Vandermosten from Zacks. Go ahead, John.
John Vandermosten: Hey, thank you. And John, Jerry, Cindy, good afternoon to your guys. I wanted to ask — extend the question on the demographics of the patients. They were younger. Any other details you can give us on perhaps such economic makeup or something else about them that perhaps is different than the normal smoker?
Cindy Jacobs: Yes, we did not collect any socioeconomic information as they came in. We do see that roughly females and males are coming in, maybe a little more females, but that — it’s pretty average. I think the younger age is probably the one that stood out the most. Like, I said in the 20s and 30s, where our average on ORCA-2 was about late 50s.
John Vandermosten: Okay. And I think vapers are actually taking material enough more nicotine than smokers are. Does that change the potential efficacy of cytisinicline in any way, maybe perhaps a longer duration treatment or something may be more effective or shorter, but wondering if you have any comments on that?
