FDA's Sarepta ruling injects a shot of reality into the biotech world

11/14/2013 | Forbes

The FDA recently told Sarepta Therapeutics not to file for fast-track approval of eteplirsen, a drug candidate for Duchenne muscular dystrophy, sending the company's share prices down and dashing the hopes of children with the debilitating disease and their parents. The decision presents a warning for biotechnology investors, Matthew Herper writes. "One of the key ideas that has driven biotechnology stocks into a frothy bubble is the perception that the FDA has become friendlier to companies than it was before. Either that is no longer true or it never really was," he writes.

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