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FDA Accepts Complete Response Submission Regarding Hemispherx Biopharma Inc's Ampligen New Drug Application For Chronic Fatigue Syndrome
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.
Latest Developments for Hemispherx Biopharma Inc
- Hemispherx Biopharma Inc Receives Complete Response Letter From FDA on Ampligen New Drug Application For Chronic Fatigue Syndrome
- Hemispherx Biopharma, Inc. Files Complete Response With FDA Regarding Ampligen New Drug Application For Chronic Fatigue Syndrome
- Hemispherx Biopharma, Inc. Announces Filing New Drug Application In Argentina For Ampligen To Treat Chronic Fatigue Syndrome
- Hemispherx Biopharma, Inc. And FDA Reach Agreement On Filing Requirements For Complete Response In Support Of Ampligen New Drug Application For Chronic Fatigue Syndrome Treatment
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