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Article: FDA Wants More Trials Neurocrine Falls 49% On Second Approvable Letter For Indiplon.
- Article from:
- BIOWORLD Today
- Article date:
- December 14, 2007
- Author:
CopyrightCOPYRIGHT 2007 A Thomson Healthcare Company. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan. All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)
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Byline: Trista Morrison, Staff Writer
The FDA delivered a second approvable letter for Neurocrine Biosciences Inc.s insomnia drug indiplon, surprising the company and investors with requests for additional clinical and preclinical studies.
During a conference call, Neurocrine President and CEO Gary Lyons said the company had been in labeling discussions with the agency for three weeks and had received no evidence that it should expect anythingshort of an action going forward allowing us to market and commercialize this product.
Neurocrines unnamed potential commercialization partner for indiplon was also surprised by the news. Lyons said ...