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Sarepta Complained To Woodcock About Exondys 51 Review Early And Often

 
• By Derrick Gingery

Documents also show that Sarepta officials begged CDER director for approval on multiple occasions prior to the agency's September 2016 decision.

FDA entrance sign 2016

Sarepta Therapeutics Inc. officials appeared unafraid of asking Center for Drug Evaluation and Research Director Janet Woodcock questions or even complaining about review division requests, while the US FDA was reviewing its application for the Duchenne Muscular Dystrophy Treatment Exondys 51 (eteplirsen).

Emails and other documents released Sept. 6 as part of a Freedom of Information Act request appear to show that a more casual relationship had developed between Woodcock and the company

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