Eteplirsen Review Offers Lessons For FDA, Advocacy Groups, Industry

21 Sep 2016
Analysis

Sue Sutter @PinkSheetSutter sue.sutter@informa.com

Executive Summary

Agency reviewers believed the line between patient input and external intimidation had been crossed; early data from the Sarepta muscular dystrophy drug's flawed development program stoked patient community expectations and made regulatory review difficult.

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Eteplirsen Review Offers Lessons For FDA, Advocacy Groups, Industry

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