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BioPharmaceutical United States Advisory Committees

Sarepta's Additional Data Doesn't Sway FDA On Eteplirsen

This article was originally published in The Pink Sheet Daily

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Executive Summary

Agency reviewers raise more concerns about efficacy of proposed Duchenne muscular dystrophy treatment despite new information.

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Witnesses call for political pressure on FDA to approve the Duchenne drug; patients and advocates also urge general approval reciprocity with Europe and incentives for pediatric trials; agency was not invited to testify.

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