CDER Director Janet Woodcock gave a candid opinion of the importance of the approval of the Duchenne muscular dystrophy drug Exondys 51 (eteplirsen), as well as the health of its sponsor,Sarepta Therapeutics Inc., during FDA's internal battle over the decision.
Woodcock's Consideration of Sarepta Financial Issues Raises Eyebrows
CDER Director tells FDA appeals board that Duchenne muscular dystrophy development could suffer if Sarepta's drug not approved.