FDA denies third Genasense appeal

Genta (OTCBB:GNTA) said that in response to the company's appeal of a December 2008 complete response letter for Genasense oblimersen to treat relapsed or refractory chronic lymphocytic leukemia (CLL), FDA reiterated that an additional trial would be required before approval. In July 2008, Genta had submitted new data to FDA after the agency denied the company's second formal appeal of a 2006 not approvable letter for the antisense agent targeting Bcl-2 mRNA. The company is now considering its next steps. ...