FDA Accepts Hemispherx's Complete Response Submission On Ampligen NDA For CFS

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8/14/2012 8:23 AM ET

Hemispherx Biopharma Inc.(HEB: Quote) said that the US Food and Drug Administration has accepted the company's complete response submission regarding the Ampligen New Drug Application for Chronic Fatigue Syndrome or CFS.

Hemispherx Biopharma had said it filed on July 31, 2012 with the U.S. Food and Drug Administration its complete response to the FDA's November 25, 2009 Complete Response Letter in support of Ampligen's New Drug Application for Chronic Fatigue Syndrome.

On August 10, 2012, the FDA acknowledged in writing receipt of the Company's August 1, 2012, response stating, "We consider this a complete, class 2 response to our November 25, 2009, action letter. Therefore, the user fee goal date is February 2, 2013."

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