Roanna Ruiz: Yeah. That’s helpful. Thanks a lot.
Jay Luly: Good. Thank you.
Operator: Thank you. And I show our next question comes from the line of Jay Olson from Oppenheimer. Please go ahead.
Jay Olson: Hey. Congrats on the progress, and thanks for taking the questions. At a very high level, how long do you anticipate it will take to get regulatory approval for 235? So are we talking about a couple of years, or is it going to be several years? And how will COVID treatment dynamics evolve over that time frame? And then what are your latest thoughts about a potential partnership for the development and commercialization of 235? And then I have a follow-up question on 514, if I could, please. Thank you.
Jay Luly: Sure. So those are some big questions, actually, the future of the pandemic and how that will play out over time is, one, that’s continued to vaccine. Clearly, we’re — at least for now, we seem to be getting into an endemic phase. Maybe we’re at the beginning of the end of the pandemic phase shifting toward endemic, that even that’s going to be probably several years away before it’s truly in the endemic phase. I think the trends in terms of regulatory pathway that’s available, I think that’s also going to be something that will be looked at carefully as we progress through development. There’s different assumptions depending upon what variants that might emerge. But right now, our focus is on finishing up SPRINT and having data in the first half, moving into a Phase 3 study in the back half of the year, and conducting that as expeditiously as we can.
I think EUA is still an option as far as we are aware, at least in certain patient populations. And so — but will that be the case later? Really you really need to let it play out in terms of the timing of the program, juxtapose the backdrop of the environment that’s going on. One of the interesting things about the variants is they’re changing all the time. It was not that long ago that, we were talking about BA.4 and BA.5. Within the last few weeks BQ.1 and 1.1 have all been taken over and immersively, the €“ they don’t seem to be as lethal as certainly some of the earlier variants, which is good, but these things can switch all around. So yeah, we’ll just be watching the landscape and that’s going to dictate a lot of how our Phase III enrolls in what patient population, what regulatory pathways are available to us at that time.
There’s still an unmet €“ huge unmet need for antivirals. The vaccination rates have probably stabilized to a great degree and there’s some vaccination fatigue out there. The antibodies also continue to be losing efficacy. And many of them, as you know, have dropped off in terms of being effective so far, and there really aren’t that many therapeutics that are mechanism-based and well understood that are going forward. So this is a really large market opportunity. It’s going to be one pretty much going forward and one in which there aren’t €“ I would submit that, the optimal therapies are not yet approved. We look at 235 as having a very strong profile in that regard. So that part, I think the need for therapeutics will be very high. It’s been extraordinarily well too, as you know, with our respiratory portfolio, not just in COVID, but obviously, the breadth of all the RSV set that we just have been talking about this evening as well as human metapneumo.
Again, human metapneumo something you’re going to continue to hear more and more about as these things are being under the spotlight increasingly. Partnering is still the plan. Again, this is going after a pandemic virus on a global scale is the bigger than we are, and it’s our goal to really maximize 235 globally to the greatest patient base we could possibly serve and in order to achieve that, we will be seeking a global partner in our efforts here.
