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FDA Accepts Complete Response Submission Regarding Hemispherx Biopharma Inc's Ampligen New Drug Application For Chronic Fatigue Syndrome


Tuesday, 14 Aug 2012 08:00am EDT 

Hemispherx Biopharma Inc announced that it filed on July 31, 2012 with the U.S. Food and Drug Administration complete response to the FDA's November 25, 2009 Complete Response Letter in support of Ampligen's New Drug Application for Chronic Fatigue Syndrome (CFS). On August 10, 2012, the FDA acknowledged in writing receipt of the Company's August 1, 2012, response stating, "It considers this a complete, class 2 response to November 25, 2009, action letter. Therefore, the user fee goal date is February 2, 2013. 

Company Quote

0.2508
8.0E-4 +0.32%
3:59pm EDT