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HEB > SEC Filings for HEB > Form 8-K on 21-Dec-2012All Recent SEC Filings

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Form 8-K for HEMISPHERX BIOPHARMA INC


21-Dec-2012

Other Events


Item 8.01 Other Events.

On December 21, 2012, Hemispherx Biopharma, Inc. (the "Company") issued a press release regarding the results of a public U.S. Food and Drug Administration ("FDA") Arthritis Advisory Committee (the "AAC") meeting on December 20, 2012 which considered the Company's pending new drug application ("NDA") for Ampligen® for the treatment of chronic fatigue syndrome (CFS), including the 8 to 5 vote of the AAC against a finding that "the applicant provided sufficient efficacy and safety data to support marketing of Ampligen for the treatment of CFS."

The Prescription Drug User Fee Act date for completion of FDA review of the Ampligen® NDA is February 2, 2013. The AAC provides FDA with independent expert advice and recommendations, but the final decision regarding approval of a medication is made by the FDA.

For more information about the AAC hearing and the vote, please see the press release attached as Exhibit 99.1 to this Current Report on Form 8-K which is incorporated by reference herein

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