Tim Lugo: Thanks for the question. You mentioned earlier in the week that you didn’t expect an additional advisory committee for broadening the label. But we can all remember when we did expect one for the accelerated approval discussion. I guess why not request an AdCom? It seems like listening to the AdCom, the participants were much more amenable to non-age-restricted approval than the agency was.
Douglas Ingram: Yes. Okay. So it’s a good question, and I’m not surprised by the comment. There are those that might say that I have a poor historical track record of predicting AdComs. Notwithstanding the factor the last time I said we were going to have AdCom, I did have that in writing. The reason that we don’t believe we’re going to have an AdCom is that we don’t believe that we will need one. And I think that — I believe, as we sit here today, that, that is a view that would be shared by us and FDA leadership. As we’ve said before, — we had a very productive and encouraging discussion with the FDA leadership on the data and on the possibility of submitting it for a broad label. And I would also note that the agency has changed the division, in particular, has gone through some pretty significant changes over the course of this year.
There’s been a reorganization just to remind you where OTAT has been replaced by the super office OTP. And not too long ago, a new leader, Dr. Nicole Verdun, took the helm as the Head of OTP. So I would say were not to remember that the division is evolving. Obviously, in the event that there was an advisory committee, we would be well prepared for it. And I believe we would perform exceptionally well there. I think Dr. Rodino-Klapac and team just did a fabulous job representing us. And as one may recall, we did ultimately win that AdCom. But as we sit here today, we feel pretty confident that we can get a little expansion without an advisory committee.
Tim Lugo: Alright. Thank you.
Douglas Ingram: Thank you very much.
Operator: Please standby for the next question. The next question comes from Gil Blum with Needham & Company. Your line is open.
Gil Blum: Good afternoon and congratulations on all the progress. Going back to a question, a follow-up on Alan’s [Ph] earlier questions about any questions ago. So if you are on Study 102. Is there — any chance that there would be some follow-up, especially on the patients that were older and were crossed over in part 2 of Study 102 regarding time to rise. It will be interesting to see how that data looks in comparison to the EMBARK data. Thanks.
Douglas Ingram: Sure. Louise, any thoughts on that?
Louise Rodino-Klapac: Okay. Although one or two patients are continued to follow for up to 5 years. So that’s certainly something that we can look at over time. We don’t have that data at hand, so we can look at that.
Operator: Please standby for the next question. The next question comes from Brian Abrahams with RBC Capital. Your line is open.
Brian Abrahams: Hi there, congrats on the strong first full quarter of the ELEVIDYS launch. Thanks for taking my question. Can you remind us of the protocols in place in EMBARK to protect against functional unblinding — was this a topic that ever came up with the FDA in your recent discussions? And why you expect any differences in the effect functional and blinding, if there was any, it might have on time tests versus on NSAA? Thanks.
Douglas Ingram: Yes. I can allow Louise to discuss the protocol aspects of the blinding process, which was exceptionally rigorous. We can generally assume that if that these are very objective time test would be less subject to any kind of influence in the event there wasn’t unblinding. But I would say also that I think the protocol was very good about the blinding process and the study itself, one should remember, was actually very well run. I want to be clear about that. Louise any thoughts on the blinding process.
Louise Rodino-Klapac: Just specifically so the patients and caregivers obviously blinded the PIs as well as the physical therapist doing the functional tests are all completely blinded. So the studies is maintain blinded, study staff disrupt is blinded. It’s maintained by a third party. So there is a rigorous process in place to make sure that the blinded remains intact.
Brian Abrahams: That’s helpful. Thank you.
Operator: Please standby for the next question. The next question comes from Kristen Kluska with Cantor Fitzgerald. Your line is open.
Jason Bouvier: Hi, good afternoon. This is Jason Bouvier on for Kristen Kluska. Thank you for taking my question and congrats on the strong quarter for ELEVIDYS. One question from us, the cadence treating patients is going faster than the original time lines you laid out. So we’re just wondering what the biggest drivers are there? And how might this also impact the potentially broader launch next year? Thank you.
Douglas Ingram: Well, I’m going to take the question even though Dallan wants to be, because I want to brag about our team. I mean I think there’s two significant reasons why the cadence of this launch is going exceptionally well and why this launch is it, from my perspective, an unprecedented success in gene therapy, the first of which, of course, is the therapy itself. ELEVIDYS is an extraordinarily needed therapy that patients who have been on it and families that share their experience with strongly of the belief that they need this therapy, and these kids have been stabilizing or doing things age-specific that untreated kids haven’t been able to do. And then if you don’t mind me bragging a little bit about the team. I mean this is an example of exceptionally great execution by the Sarepta folks led by Dallan — Customer Officer, by going beyond that, this is our manufacturing and distribution folks as well, just a large team effort to execute on this.
And this isn’t new for us. I want to remind everyone now that we have now four therapies that we have launched. Every one of those therapies and their launches have gone exceptionally well. I mean if we look at the P&L, it’s just digress for a moment. I mean we are now from our first PMO that was approved in late 2016. We’re still growing. We grew at 16% quarter over the same quarter last year, even as we’re launching ELEVIDYS is doing brilliantly there. So I think there’s a combination both of the great therapy as all of our four therapies, I believe, have been and exceptional focused, granular, well-informed execution. And what does this mean for the future? It means that we know how to serve the Duchenne community and one of the things that excites us about a broader label is we’ll be able to bring ELEVIDYS to the majority of children and young men in the United States that are living with and generating irreparably from this ferocious disease.
And so I’m really excited about the opportunity to bring this therapy to more patients even as we’re doing really well with the launch right now. Thank you very much for your question. Thank you very much for your question.
Operator: Please standby for the next question. The last question comes from Joseph Schwartz with Leerink Partners. Your line is open.
