Hemispherx Biopharma (HEB) and the FDA Reach Agreement on Filing Requirements for the Company's Complete Response in Support of Ampligen(R) New Drug Application for Chronic Fatigue Syndrome Treatment
7/11/2012 9:45:30 AM
PHILADELPHIA, July 11, 2012 (GLOBE NEWSWIRE) -- Hemispherx Biopharma, Inc. (NYSE:HEB) (the "Company" or "Hemispherx") recently met with representatives of the U.S. Food and Drug Administration (the "FDA"). At that meeting, the FDA agreed to accept, for review, new analyses of data from Hemispherx's AMP-516 Phase III Clinical Trial ("AMP-516 Trial") in support of its New Drug Application ("NDA") for Ampligen® (Poly I : Poly C12U). If found sufficient to support approval of the drug, these new analyses will be in lieu of an additional confirmatory Phase III study called for in the Agency's November 25, 2009, Complete Response Letter ("CRL"). The FDA has advised that whether the new analyses provide adequate evidence of Ampligen®'s efficacy in treating Chronic Fatigue Syndrome ("CFS") will ultimately be a review issue.