Sarepta Therapeutics, Inc. (NASDAQ:SRPT) Q4 2022 Earnings Call Transcript

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Doug Ingram: It won’t be a major amendment because our BLA went in with the assumption that we would have a narrower exclusion. We already had good scientific rationale for why the labeled exclusions needed should be narrower, that we were being overly exclusive in those mutations. And then to support that thesis we’ve started this and we’re nearly done enrolling a study to explore those mutations. It’s going quite well right now. But our initial BLA went in with the request that we have a narrower exclusion in our proposed label in connection with our initial BLA submission made that same assumption.

Operator: Our next question comes from the line of Salveen Richter .

Unidentified Analyst: It’s Tommy on for Salveen . Congrats on the progress. Just wondering how you’re thinking about uptake in between that period after the Accelerated Approval but before EMBARK reads out. Any physician or payer commentary that some might wait to prescribe to see EMBARK? And can you just remind us how long it takes for patients to get tested for eligibility?

Doug Ingram: So we don’t — with our current thinking based on all of our discussions both with thought leaders and with certainly patient groups and families is that people wouldn’t wait — waiting is not a viable option for people with this degenerative disease. I would note that by the end of this call, somewhere around the world, a kid with Duchenne will have died and another kid will be going on event. And another kid will go into a wheelchair, never to get back out of a wheelchair. So the luxury of patients isn’t there for these families. So we don’t intend to — we don’t imagine that people would wait for other readouts down the road and put their kids at risk, at least that’s not our current assumption nor do we think it’s the assumption of the treating physicians either. Certainly, those who have seen what 9001 can do, I don’t think would want to wait. As far as the process, Dallan, do you want to touch on the process itself.

Dallan Murray: Yes. Yes. And just to underscore what you said about the urgency, Doug. That’s what we’re seeing out there as well. And I think in terms of what the team has for the process, the data is to have a fully enrolled confirmatory trial at the time of approval is just — is such an incredible position to be in. And so that’s going to inform all of our dialogue going forward on this.

Operator: I’m showing no further questions at this time. I’d like to turn the call back over to Doug Ingram for any closing remarks.

Doug Ingram: Well, thank you very much, everyone, for joining us this evening and for your very good questions. It is a point any. I think as Dr. Rodino-Klapac back noted that today is indeed Rare Disease Day. We are completely committed to using great science and moving as fast as possible to bringing a better life to Duchenne patients and beyond Duchenne patients to other rare disease patients. And I look forward to updating people along the way. Although I will note yet again that as it relates to the BLA for 9001, the next substantive update you’ll get is on or around May 29 which is our action date. So, thank you all very much and have a lovely evening.

Operator: Thank you. Ladies and gentlemen, this does conclude today’s conference. Thank you all for participating. You may now disconnect. Have a great day.

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