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Golodirsen Rebuff: Did Exondys 51 Review Strife Influence US FDA's Decision?

20 Aug 2019
Analysis

Michael Cipriano @mcipriano93 michael.cipriano@informa.com

Executive Summary

Sarepta cited two safety issues when announcing a complete response letter for its exon 53 skipping DMD drug golodirsen, but the US FDA's decision may be a result of the Exondys 51 approval from 2016, analysts suggest.

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BioPharmaceutical

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Sarepta Therapeutics Inc.

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Complete Response Letters Drug Review Regulation

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Golodirsen Rebuff: Did Exondys 51 Review Strife Influence US FDA's Decision?

Analysis

Executive Summary

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Golodirsen Rebuff: Did Exondys 51 Review Strife Influence US FDA's Decision?

Analysis

Executive Summary

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