CBER Director Marks’ Intervention On Sarepta Gene Therapy Filing Decision Appears To Backfire

 
• By Derrick Gingery

Former OTAT Director Wilson Bryan says Peter Marks’ order to file Sarepta’s DMD gene therapy application was mainly a public relations move, which does not seem to have worked in the FDA’s favor. Upcoming advisory committee could now involve as much scrutiny of the agency as the application itself.

backfire
Stakeholders likely will closely watch the upcoming FDA advisory committee meeting on Sarepta's DMD gene therapy candidate. • Source: Shutterstock

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