Hemispherx Biopharma Inc. (HEB) announced the outcome of the meeting of the Arthritis Advisory Committee of the U.S. Food and Drug Administration on the New Drug Application or "NDA" for Ampligen for Chronic Fatigue Syndrome or "CFS".
The vote was 8 to 5 against recommending the approval of Ampligen. However, the Advisory Committee backed safety profile of Ampligen.
Hemispherx said it is committed to the Ampligen clinical development program and to bringing Ampligen to market to ease the suffering of those seriously afflicted with CFS. The company said it will also continue to work closely with the FDA to support the review of this investigational compound. Hemispherx will seek to do everything necessary to confirm in a scientifically rigorous manner that Ampligen is a safe and effective treatment for CFS.
The Prescription Drug User Fee Act ("PDUFA") review goal for the FDA to complete its review of the NDA is February 2, 2013.
HEB is currently trading at $0.28, down $0.08 or 21.39 percent.
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