Sarepta Therapeutics Inc SRP-9001 BLA Update Call Transcript

Mar 16, 2023 / 08:30PM GMT
Operator

Good day, and thank you for standing by. Welcome to the Sarepta Therapeutics SRP-9001 BLA update conference call. (Operator Instructions) Please be advised that today's conference is being recorded.

I would now like to hand the conference over to your speaker today, Doug Ingram, President and Chief Executive Officer. Please go ahead, sir.

Douglas S. Ingram - Sarepta Therapeutics, Inc. - President, CEO & Director

Thank you, Norma. Good evening, and thank you for joining our update call regarding the Biologics License Application, or BLA, for SRP-9001, our investigational gene therapy to treat Duchenne muscular dystrophy. As you will have seen in our accompanying release, we completed our late-cycle review this week and the FDA's Office of Therapeutic Products, or OTP, has now determined that they will hold an advisory committee, or Adcom, meeting for the SRP-9001 BLA.

As Duchenne muscular dystrophy is a devastating and life-ending disease and time is of the essence for the thousands of families living with Duchenne, the Center for Biologics

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