The Food and Drug Administration is delaying what will probably be the most controversial decision it will make this year. But what does that delay mean?
Sarepta Therapeutics, a start-up firm developing a drug called eteplirsen for Duchenne muscular dystrophy, said yesterday the FDA won’t meet its official deadline for a decision, which was supposed to be today. Sarepta shares popped 20% yesterday because investors see the indecision as better than the rejection they were expecting. The FDA gave no guidance on timing, and can essentially take as long as it needs.
