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Sarepta, US FDA Offer Sparring Positions Over Release OF Complete Response Letters

 
• By Michael Cipriano

Following Vyondys 53 rebuff, Sarepta CEO contends it would be "disrespectful" to release the complete response letter, while FDA contends that there is nothing stopping companies from publishing the letters.

As Sarepta Therapeutics Inc. begins to assess a path forward for its recently-rebuffed Duchenne muscular dystrophy (DMD) drug Vyondys 53 (golodirsen), the drugmaker and the US Food and Drug Administration have taken sparring positions about the decisions of companies to voluntarily release complete response letters (CRLs) to the public.

During a webinar conversation between Sarepta and Parent Project Muscular Dystrophy (PPMD) released on 22 August, company CEO Doug Ingram said multiple times that it might be "disrespectful" for Sarepta...

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