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Rare Diseases Drug Review Regulation

Sarepta Complained To Woodcock About Exondys 51 Review Early And Often

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Executive Summary

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

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This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

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