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Woodcock's Consideration of Sarepta Financial Issues Raises Eyebrows

Executive Summary

CDER Director tells FDA appeals board that Duchenne muscular dystrophy development could suffer if Sarepta's drug not approved.

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Sarepta Should Gain Clean Slate With CBER Review of DMD Gene Therapy

Sarepta will face a US FDA staff with which it does not have a controversial history, the Center for Biologics Evaluation and Research, likely avoiding the reviewers that evaluated its Duchenne muscular dystrophy treatment Exondys 51.

Sarepta Complained To Woodcock About Exondys 51 Review Early And Often

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

Woodcock's 'Bias' In Sarepta Case Made Jenkins Worry About Future Drug Reviews

In memo to then-Commissioner Califf during review of Sarepta's Exondys 51, Jenkins wrote that he was concerned about leaving OND in hands of CDER director upon his retirement.

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