Hemispherx Biopharma (HEB) Files Complete Response With the FDA Regarding Its Ampligen® New Drug Application for Chronic Fatigue Syndrome
8/1/2012 9:25:13 AM
PHILADELPHIA, Aug. 1, 2012 (GLOBE NEWSWIRE) -- Hemispherx Biopharma, Inc. (NYSE:HEB) (the "Company" or "Hemispherx") filed yesterday with the U.S. Food and Drug Administration its complete response to the FDA's November 25, 2009 Complete Response Letter ("CRL") in support of Ampligen®'s New Drug Application for Chronic Fatigue Syndrome ("CFS"). As previously reported, at a recent meeting with the Agency, Hemispherx reached agreement on the filing requirements for the Company's complete response (please see the Company's press release and Form 8-K dated July 11, 2012). The FDA has indicated that the new submission will be reviewed on a 6 month cycle. The Ampligen® data were organized and filed with the FDA 53 days after the June 8, 2012 meeting with the Agency. At present, no drug has received FDA approval to treat CFS, a chronic, seriously debilitating disease.
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