9/27/2012 8:00:02 AM
Three years after being rejected by U.S. Food and Drug Administration, Hemispherx Biopharma (HEB) is back seeking regulatory approval for Ampligen, its controversial therapy for chronic fatigue syndrome. Everyone loves a comeback story with a happy ending, but Hemispherx's second attempt won't turn out any happier than the first. FDA is likely to reject Ampligen again because Hemispherx ignored the agency's demand to run a new clinical trial in chronic fatigue syndrome. Instead, Hemipsherx has spent the past three years doing essentially nothing but re-analyzing data from the old Ampligen phase III trial completed in 2004. FDA reviewed the original study already, deeming it "lacking credible evidence of efficacy of Ampligen."
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