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FDA Postpones Advisory Committee Meeting to Review Eteplirsen Due to Severe Weather Storm in the Washington D.C. Area; A future meeting date will be announced in the Federal Register

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SRPT

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Additional Information

Additional Relevant Details  In the event of a change in the February 26, 2016 PDUFA date, the company will provide an update at that time.The Advisory Committee was scheduled to review Sarepta’s New Drug Application (NDA) for eteplirsen, for the treatment of Duchenne muscular dystrophy (DMD) amenable to exon 51 skipping. The new drug application (NDA) for eteplirsen is being reviewed under the FDA accelerated approval pathway, which allows early approval of a drug for a serious or life-threatening illness that offers a benefit over current treatments.
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Catalyst Date
Occurred on:
Jan 20, 2016
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Related Keywords Fda, Delay, Advisory Committee Meeting, Eteplirsen