Georgi Yordanov: Thank you. Thank you. Yeah, we’re very excited about the asset. And then just finally, can you remind us of the powering assumptions for DAVIO 2 and specifically, if the trial is positive, and you hit in terms of non-inferiority, could it potentially serve as one of the two pivotal studies?
Nancy Lurker: Yeah, let me — we’ve stated this before but I’m going to say it again, this is not powered for a P value of 0.5, I want to be very clear about that. And I’ve said that multiple times. We did not believe, first of all you also have to go out longer in time, as you saw the FDA just issued guidance on these Phase 3 pivotal trials, and wet AMD, and they were very clear. You have to go out nine months, you have to have two dose arms, and a number of other things. The good news is, because we’ve had our type teaming with the FDA, our planned Phase 3 pivotals, which takes time, I want again reiterate to plan for and develop the right doses and begin to produce the clinical supplies, so that you’re ready to go. We followed what the FDA said and based on the guidance that was just issued, we feel we’re in a great spot in terms of our pre-planning that’s occurred and we don’t have to deviate at all.
So that’s the great news. But we do not expect that this will count as a pivotal and again, why did we do that? Because these are expensive, large global trials. I can point to any number of companies in this space, I shouldn’t say any number, but a few that went from Phase 1 straight to pivotal and failed. You have to have a robust database, you’ve got to be confident in the data that you’ve got, and we look forward to the readout of our Phase 2. As I mentioned, we expect that to be 144 patients, coupled with our Phase 1, and what was done in the oral database, we think we’ll have a robust database to make wise decisions going into pivotal studies. By the way, we do plan to run those both in parallel and as a result, we still believe that we are in a great spot competitively to get to market in a fast way.
Jay Duker: Can I just add one more comment to that? It really — it won’t be a pivotal for reasons that Nancy stated. But I think if you look at our Phase 2 design and say how will the pivotal differ, basically, in just two ways. The major way that it’s going to differ is we’re going to do reinjection and the second is the time. The FDA asks for nine months after your study drug is injected at a minimum for efficacy and they want to your safety. So this we’re having a readout in DAVIO 2 of six months after 1901 goes in. So that’s the — will be the at least in the planning stage right now, the major differences between the Phase 2 in the pivotals.
Georgi Yordanov: This is great. Thank you so much. It’s super helpful. And congratulations again on the progress.
Nancy Lurker: Thank you.
Operator: Thank you. One moment for our next question. And that will come from the line of Jennifer Kim with Cantor Fitzgerald. Your line is open.
Jennifer Kim: Hey, everyone, thanks for taking my questions. I have a few here. Maybe to start off with timelines for 1901. I think you said that the data is coming by year-end of this year and I’m wondering, does that language reflect anything in terms of, I guess, like what you’re seeing in terms of enrollment? And then same with PAVIA, that seems all on track, so how does enrollment look for that trial? And then DME, I think that timeline, you said later this year or early next year, is there anything that sort of like pushed that timing? Thanks.
