Hemispherx Biopharma (HEB) Announces FDA Advisory Committee Will Review Ampligen® for Chronic Fatigue Syndrome
9/24/2012 9:30:00 AM
PHILADELPHIA, Sept. 24, 2012 (GLOBE NEWSWIRE) -- Hemispherx Biopharma, Inc. (NYSE MKT:HEB) (the "Company" or "Hemispherx") today announced that the U.S. Food and Drug Administration ("FDA") has tentatively scheduled an Advisory Committee ("AC") meeting to discuss the Ampligen® New Drug Application for Chronic Fatigue Syndrome ("CFS") which is currently under review by the FDA. The date of the AC review has been tentatively set for December 20, 2012. As previously announced, the Prescription Drug User Fee Act ("PDUFA") review goal for the FDA to complete its review is February 2, 2013.