Operator: Our next question comes from Alex Nowak with Craig-Hallum. Please go ahead.
Alex Nowak: Okay, great. Good morning, everyone. With the enrollment ramping here, 220 sites, multiple countries, you’re now looking — you’re doing the indication expansion into prostate, what additional investment in the talent side, resources, whether it be in Minnesota or other geographies, do you need to plan for here?
Brian Sullivan: We’re adding staff to our team throughout. We have added people to our team. We’ll continue to add people to our team. They typically will not be at the senior executive level. And those folks are there to support just the day-to-day activities of managing a study as significant as VIKTORIA-1, but also to help us prepare ourselves for a new drug application, or NDA. And so, we have to simultaneously execute our Phase 3 study while also preparing for an eventual NDA submission. And so, as we get closer to an NDA submission, that activity starts to ramp up, we’ll add staff accordingly. But the investments from a G&A perspective will still be relatively modest, but there will be some increase in headcount as a result of our progress towards the NDA.
Alex Nowak: Got it. That makes sense. And then, the R&D expense pick-up this quarter, I mean, is that — is it fair to say that’s a direct indication that the enrollment for the trial is going, let’s say, better than initially expected?
Brian Sullivan: I would say it’s just in line with what we expected. So, as you enroll more patients, you have certainly expenses associated with that. As more patients are on the drug, there’s more expenses associated with that. And so, I think what we’ve reported is pretty consistent with what the expectations have been for our expenses.
Alex Nowak: Okay. Makes total sense. And then just recently, with enrollment creeping higher here, has there been any major kind of recruitment protocol changes that have been made to the study?
Brian Sullivan: No. So far, so good. It clearly requires a lot of very hands-on work with the sites, ensuring that trial has visibility not only with the principal investigator, but they’re typically multiple investigators, sub-PIs that can enroll patients. And so, we have a very deliberate approach to staying in contact with the multiple individuals involved with the study. We’re constantly assessing the patients they may have who could potentially be eligible for the study down the road if they progress on their current CDK4/6 therapy. And so, we have multiple ways of gauging what the potential activity could be at the site, and also just multiple ways of ensuring that we’re as top of mind as we can, and so far, so good. But we have roughly 220 sites.
So that means we have to stay in touch with a lot of individuals. And — but we think we have a very good approach to not only execute that, but also keep track of it. And then, to the extent that we see any site that may be not living up to our expectations, we’re following up with them and digging into any potential obstacles that they may think they have that could be preventing them from screening patients.
Alex Nowak: All right. Well, great to hear. Appreciate the effort. Thank you.
Brian Sullivan: You’re welcome.
Operator: There are no further questions at this time, so that concludes our Q&A session. I would like to turn the floor back over to Brian Sullivan, CEO, for closing comments.
Brian Sullivan: Well, thanks again for participating in our call today and for your ongoing support. We’ll be participating in the upcoming Stifel Healthcare Conference and Jefferies London Healthcare Conference next week, and look forward to hopefully seeing many of you there. Good-bye.
Operator: This concludes today’s teleconference. You may disconnect your lines at this time. Thank you for your participation.
