Sarepta’s Golodirsen Rejection: Do We Really Need The US FDA’s Letter?
Rejection of Sarepta’s golodirsen has become latest flashpoint in debate over release of complete response letters. In this case, though, FDA’s reasoning seems fairly obvious, based on the prior eteplirsen review.
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Following Vyondys 53 rebuff, Sarepta CEO contends it would be "disrespectful" to release the complete response letter, while FDA contends that there is nothing stopping companies from publishing the letters.
The review manager most opposed to the eteplirsen approval offered his views of the process that led to the final decision and the 'circus' atmosphere of the advisory committee.