Ilya Zubkov: All right. Thank you.
John Bencich: Thanks, Ilya.
Operator: Thank you. And our next question comes again from Michael Higgins with Ladenburg Thalmann. Please proceed with your question.
Michael Higgins: Thanks again, guys, for taking a few more follow-ups here. Can you help us with your conversations with the FDA and NIH on vaping, what that may look like throughout this year? I know you want to get that going. You’ve had your hands full with OLE and all that’s been happening there, but just trying to get a better sense for the timing with the vaping programs and your discussions. Thanks.
John Bencich: Yes. So the focus on the vaping indication really is going to be the end of Phase 2 meeting with the agency. So now that we’ve got the ORCA-V1 trial complete. We’re able to share that with the agency again under the guides of an end of Phase 2 meeting to get clarity on the path forward. As we’ve indicated before, our belief is that a single Phase 3 trial is what will be required to open up the label and expand into nicotine e-cigarette cessation. But we need clarity on that. So that is a high priority for us this year and something, we’d hope to get clarity on in the second half of this year.
Michael Higgins: Okay. Sounds good. We’ll sit tight for that. Thanks for that. And then second one here being manufacturing, it sounds like the sites are open and so forth. You have enough supply at this point? Is that still coming on board in the summer months and into the fall? Just trying to understand that the manufacturing is ready to go for OLE. Thanks.
John Bencich: Yes. Thanks, Michael. On the manufacturing side of things, this probably is the gating item to initiating centers and getting folks back into the clinic for the ORCA-OL trial. The tablets have all been made, and we’re in the process here in the coming weeks to get that blister packed and ready for the clinic. So everything’s on track to move that ORCA forward here in the coming weeks, so we can initiate the ORCA-OL trial.
Michael Higgins: Awesome. Okay. Sounds good. And then finally, I noticed the OpEx in Q4 was lighter than we had expected. Congrats on that. And then we look ahead to ORCA-OL and trying to get an assessment or some sort of a gauge as to how the cost may be compared to ORCA-2 and ORCA-3. It’s longer, but less frequent visits. Just trying to get a sense in comparison to the trials, how this cost may come out. Thanks.
John Bencich: Yes. Thanks, Michael. With respect to the costs for ORCA-OL, we’ve currently estimated this as a roughly $20 million trial that will come in basically over the course of 2024 and 2025. So while the visits are less frequent, the overall number of visits is similar to what we’ve seen in our previous studies, just over a longer period of time. And as Cindy articulated, what we’re doing at those visits is very consistent. And the bulk of the cost of these studies is the patient recruitment cost. So the bulk of the expense will come in as the patients are enrolled and complete their therapy. So we’ll see some of that cost kick off here in Q1 and then drive the bulk of it through the first part of next year. So hopefully that’s helpful in kind of modeling out the OL expensive.
Michael Higgins: That certainly is. Appreciate all the feedback. Thanks, guys. Congrats again.
Operator: Thank you. And we have reached the end of the question-and-answer session. I’ll now turn the call back over to John Bencich for closing remarks.
John Bencich: Thanks, operator, and thanks, everyone, for joining us today. Appreciate all the continued support. We’ve made a huge amount of progress here recently to get clarity from FDA and really move forward quickly with the ORCA-OL trial, and we look forward to providing additional updates as we proceed and look forward to continue to stay in contact. Thanks again, everyone.
Operator: And this concludes today’s conference, and you may disconnect your lines at this time. Thank you for your participation.
