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

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.

Wilson Bryan, former director of the Office of Tissues and Advanced Therapies, now known as the Office of Therapeutic Products, in the US Food and Drug Administration’s Center for Biologics Evaluation and Research, confirmed to the Pink Sheet in an interview that