Cyberonics to fight FDA's "inexplicable" VNS rejection
This article was originally published in Clinica
Executive Summary
Overruling its own panel's recommendation, the FDA has decided not to approve Cyberonics' application to market a pacemaker-like device to treat depression. The news, released before the market opened on August 12, sparked a major sell-off in Cyberonics stock. About 27 million shares changed hands, 10 times the stock's average volume, driving the price down 40% to $9.59.