Hemispherx Says FDA Will Accept Ampligen Analyses

Law360, New York (July 11, 2012, 7:56 PM EDT) -- Hemispherx Biopharma Inc. said Wednesday that regulators will accept and review new analyses of data from a Phase III clinical trial of its chronic fatigue syndrome drug Ampligen, which could relieve the drugmaker from conducting an additional study originally requested by regulators in 2009.

Pennsylvania-based Hemispherx said that after meeting with U.S. Food and Drug Administration officials in June, the agency agreed to accept and review analyses of data from the Phase III clinical trial of Ampligen published in November 2010 and March of this year....
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