Controversial Cyberonics Gets FDA "Approvable" Letter

February 3, 2005 -- In an extremely unexpected turn of events, Houston-based Cyberonics got some good news when the FDA sent an approvable letter to the company for use of its VNS Therapy device in cases of chronic depression--cases in which the depression has failed at least 4 previous medication therapies. Last August, the FDA rejected a similar application from Cyberonics, an unusual example of the FDA overruling its own advisory committee. The company’s stock price soared on the news, climbing 35%. We look at the background to the decision and the company...