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Company News: Page (1) of 1 - 12/21/12 Email this story to a friend. email article Print this page (Article printing at MyDmn.com).print page

FDA Advisory Committee Makes Recommendations on Ampligen (R) for Chronic Fatigue Syndrome By Globenewswire

PHILADELPHIA, Dec. 21, 2012 (GLOBE NEWSWIRE) -- Hemispherx Biopharma, Inc. (NYSE MKT:HEB) (the "Company" or "Hemispherx") today announced the outcome of the meeting of the Arthritis Advisory Committee (the "AAC") of the U.S. Food and Drug Administration (the "FDA") on the New Drug Application ("NDA") for Ampligen® for Chronic Fatigue Syndrome ("CFS").



On the question: "Considering the totality of the data, is there substantial evidence of efficacy for Ampligen for the treatment of patients with chronic fatigue syndrome (CFS)?," the AAC voted 9 no, 4 yes and 1 AAC member left the room and did not vote.



On the question: "Has the safety of Ampligen been adequately assessed and characterized for the treatment of chronic fatigue syndrome (CFS)?," the AAC voted 9 no, 4 yes and 1 AAC member left the room and did not vote.


On the question: "Is the safety profile of Ampligen adequate for approval for the treatment of CFS?," the AAC voted 8 yes, 5 no and 1 non-vote.



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