CBER Director Peter Marks’ decision to file Sarepta Therapeutics, Inc.’s Duchenne muscular dystrophy gene therapy application over review team objections was apparently intended to avoid controversy, but instead appears only to have escalated it as the US Food and Drug Administration heads toward an advisory committee meeting on the product.
CBER Director Marks’ Intervention On Sarepta Gene Therapy Filing Decision Appears To Backfire
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.
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