John Bencich: Sure. Thanks, Michael. Yes. On the payer front, we’ve had a number of discussions with payers over the last two or three years and I think one thing to keep in mind is that the Affordable Care Act does mandate that all FDA approved smoking cessation medications be covered. So from an access perspective, this is one of the better categories out there. With that being said, the open label trial, I think, will have the ability, like I mentioned before, to look at what happens with repeat administration. So both success initially and then retreatment again, or perhaps lack of success in an initial treatment and having success a second time around. All those sorts of data points can be used with payers as we have those discussions leading up to and on the other side of approval of this product.
So I think those are probably the most important pieces. But I think as we kind of dig in further with the data sets that we get, there could be other interesting learnings that we can leverage with the payer community.
Michael Higgins: That makes sense. Thanks for that feedback. One quick follow-up, if I could, is the monthly visits, if you find, because it’s different than the weekly before, that patients just aren’t as compliant as they were in the previous trials. Are you able to adjust along the way and seeing that and try to reach out to them more often?
Cindy Jacobs: Oh, absolutely, yes. And that’s one of the things we will be monitoring in that regard.
Michael Higgins: Very good. Appreciate it. Thanks and congrats, again.
John Bencich: Thanks, Michael.
Operator: Thank you. Our next question comes from the line of John Vandermosten with Zacks. Please proceed with your question.
John Vandermosten: Great, thank you. And hello, John, Cindy and Jerry. Good afternoon. How many – since there’s a delay relative to the first expectations on the trial, how it is this affect the work with Sopharma preparing for the FDA inspection and all the other work that you were planning to do with them?
John Bencich: Yes. Hi, John. Thanks for the question. So as we’ve spoken about further, one of the key areas of focus for us will be and continue to be working with Sopharma to ensure FDA inspection readiness. So that will continue. This gives us effectively another 12 months of preparation timing with respect to that. One of the items that we are working with Sopharma on is looking at additional CDMOs that could be side by side with Sopharma groups from both a drug substance and drug product perspective that have already been FDA approved historically that could continue to minimize any risk from an inspection perspective. So that’s something that we’re working with in addition to the continued work at Sopharma and their site.
John Vandermosten: Great. And then we saw, I guess, an explosion of generic options for varenicline recently, and I don’t know if you had seen any of the news on that or had any update for us. I know you’re keeping an eye on that on the generic side and how that’s progressing. Any new observations over the last several months?
John Bencich: Yes. With respect to generic varenicline, I believe there are six generics on the market now. So over the last 12 months that has expanded beyond endo [ph], who was the first to market. So something we continue to monitor as we proceed. And we have seen some data points. I believe there’s some recent IQVIA data that was suggesting the generic market for varenicline was on an annual run rate of roughly $450 million. And from what we’re seeing in the marketplace, that’s somewhere north of a 30% discount to where Chantix the brand left off.
John Vandermosten: Okay. Great. Thank you, John. Appreciate it.
Operator: Thank you. Our next question comes from the line of Ilya Zubkov with Freedom Broker. Please proceed with your question.
Ilya Zubkov: Good afternoon. Thank you for taking my question. Notable event a week ago, SRNT Annual Meeting, could you share any feedback received from the professional community on the presented results of ORCA program and have there any concerns about potential chronic use of the drug?
John Bencich: Yes. Thanks, Ilya, for the question. So as we talked a bit on the call, we did have a very strong reception at the SRNT meeting last week. We were able to present three different data sets, two from the Phase 3 program and then the ORCA-V1 trial results presented by Dr. Nancy Rigotti from Harvard, Mass General. I would say, overall, very well received, and I think we continue to see cytisinicline as the lead compound driving to market. There’s really not much else going on behind it that’s anywhere near the phase of development that we have with our product candidate here. So I think that’s refreshing. I think overall, the perspective is that this is a viable treatment option and a very needed treatment option in a category that hasn’t seen any new options in nearly two decades. So I think overall, great, very warm reception from a lot of the folks that we look to for input as we’ve developed this program over the last several years.
Ilya Zubkov: Thank you. And one more for me, please. Could you elaborate on the safety endpoints requested by FDA for open-label trial? Have any changes to the protocol been made in safety parameters comparing to the previous studies?
John Bencich: Cindy?
Cindy Jacobs: Sure. They – we have kind of a primary one of looking at just serious adverse events, and then after that it would be any related serious adverse events, just general treatment emergent adverse events, related treatment emergent adverse events, any clinically significant laboratory abnormalities, and pretty much after that looking at any problematic vital signs. I mean, most of these we haven’t seen in the Phase 3, but we have all of those objectives or endpoints in the open-label as similarly as we did in the Phase 3 studies.
