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February 4, 2013
19:39 EDTHEBFDA declines to approve Hemispherx's Ampligen new drug application
Hemispherx Biopharma announced that it received a complete response letter from the US Food and Drug Administration declining to approve its new drug application for Ampligen for Chronic Fatigue Syndrome. The FDA said Hemispherx should conduct at least one additional clinical trial, complete various nonclinical studies and perform a number of data analyses. In its complete response letter, the FDA set forth the reasons for this action and provided recommendations to address certain of the outstanding issues. The agency stated that the submitted data do not provide substantial evidence of efficacy of Ampligen for the treatment of CFS and that the data do not provide sufficient information to determine whether the product is safe for use in CFS due to the limited size of the safety database and multiple discrepancies within the submitted data. Hemispherx plans to request an end-of-review conference with the FDA as a precursor to submitting a formal appeal to the office of new drugs in the FDA's center for drug evaluation and research regarding the agency's decision
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April 8, 2014
08:39 EDTHEBHemispherx announces peer-reviewed publication on Apligen safety profile
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