The rejection of Sarepta Therapeutics Inc.’s proposed Duchenne muscular dystrophy therapy golodirsen caught investors and patients very much by surprise, and has thus become the latest rallying point for calls to make US Food and Drug Administration “complete response” letters public.
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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