Yale Jen: Okay, great, that’s helpful. And then maybe just add one more that regarding spots from the competitors’ news, kind of this morning. Was that something you guys also consider or it still depends?
Jay Duker: Well, yeah, like, again, I think I did address this earlier, but I’ll reiterate. We have what we believe is an agreement with the FDA it’s in writing, that we have an acceptable protocol for our pivotal trials. If that is the fastest, least risky way to proceed that’s our plan. And we’ve seen nothing at this point alter that. Obviously, it’s dependent on good-to-great data from DAVIO 2. But there may be learnings from other companies’ approach and we’ll be studying that to see if there are any learnings for us. So until the details are out, I really can’t make any comment on that except to reiterate once more, we’re very comfortable with where our program is at right now.
Yale Jen: Okay, great, and congrats on the other progress and look forward in early-December.
Operator: Thank you so much. Your next question comes from the line of Yi Chen of H.C. Wainwright & Company. Your line is now open.
Yi Chen: Thank you for taking my question. So my question is by positioning 1901 as a maintenance therapy, well, your competitors seems to target treatment naïve patient in their Phase 3 trial. Does that mean you could potentially lose part of the market in the future? I mean, could you use 1901 for treatment naive patients as well? Thank you.
Jay Duker: So if we get a label for maintenance therapy, and the label includes follow — the use of 1901 after induction with EYLEA or any anti-VEGF, let’s say hypothetically. I think doctors knowing the retina specialist community the way I do. I think doctors will try it earlier than after three induction doses, in some cases. If we’re safe, effective and tolerable, I think the argument might be, why not use it after a second induction or first induction dose? Will it be used as solo therapy initially? I think that needs to be shown that it’s effective that way. So again, the market share depends on a lot of things. And once again, one of the things we just talked about was reinjection. And the hope and expectation is we would get a label for every six months reinjection.
The FDA was clear that if we wanted to label for reinjection, we needed to test reinjection in the pivotal trials. And so I think that — if that is the way our label reads, eventually, I think that will have an advantage also. So it’s hard to predict, I will certainly admit that. But once again, we are very comfortable with where our program is at and the approach that we’re taking. And the retina community that we’ve talked to, I think, is in favor of the approach that we’re taking. And if we get that label, I think retina specialists will figure it out.
George Elston: And yeah, maybe if I can add to that, just keep in mind, the vast majority of the market is previously treated patients, and the fact that we are going to be able to read those every six months is going to be meaningful on our label. And, I think ultimately, physicians will have the opportunity to use it sooner. But as we think about our approach and the market approach, we’re addressing a very significant portion of a $10 billion-plus market. So we’re comfortable with our pathway.
Jay Duker: And I could add one more, George that was an excellent point you made about for every newly diagnosed patient, a retina specialist probably has a dozen or more previously treated patients in their practice. So once again, from a recruitment perspective, and from speed to filling a trial, there’s a lot more maintenance therapy patients out there than there is newly diagnosed. And that’s one of the many reasons why we’ve chosen this pathway, speed to approval.
Yi Chen: Thank you.
Jay Duker: Could we see if Colleen is still on the line and wants to ask a question?
George Elston: Yes. She responded. She’s having issues, number of calls this morning. So she’s — we’ll find her later.
Operator: All right. And we actually don’t have any further questions in the queue at this time. So ladies and gentlemen, thank you for participating in today’s conference. This does conclude your webcast on your program. You may now disconnect. Everyone, have a great day.
Jay Duker: Thanks, everybody.
