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News Breaks | | | | December 21, 2012 | | 15:02 EDT |  | HEB | FDA recommends against marketing of Hemispherx' Ampligen fatigue drug
Hemispherx Biopharma announced the outcome of the meeting of the Arthritis Advisory Committee of the U.S. FDA on the New Drug Application for Ampligen for Chronic Fatigue Syndrome, or 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?," 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?," 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 chronic fatigue syndrome?," the AAC voted 8 yes, 5 no and 1 non-vote. On the question: "Based on the information included in the briefing materials and presentations, has the applicant provided sufficient efficacy and safety data to support marketing of Ampligen for the treatment of chronic fatigue syndrome?," the AAC voted 8 no, 5 yes and 1 non-vote. | |
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News For HEB From The Last 14 Days Check below for free stories on HEB the last two weeks. |
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| There are no results for HEB |
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