HEB: No FDA Approval for Ampligen

December 1, 2009 - The FDA has finally come out and decided on CFS Drug, Ampligen

The Ruling? No

Shares of Hemispherx Biopharma, Inc. (HEB) are trading in the $0.70's tonight in afterhours in the wake of this news.

This doesn't appear over quite yet as Hemispherx Biopharma, Inc. is requesting a meeting with the FDA.


Link


Hemispherx Biopharma Receives Complete Response Letter from FDA on Ampligen® New Drug Application for Chronic Fatigue Syndrome

Hemispherx Biopharma, Inc. (NYSE Amex: HEB) (the “Company” or “Hemispherx”), announced that it received a Complete Response Letter from the US Food and Drug Administration (“FDA”) which describes specific additional recommendations related to the Ampligen® NDA. In accordance with its 2008 “Complete Response” procedure, the FDA reviewers determined that they cannot approve the application in its present form and provided specific recommendations to address the outstanding issues. Hemispherx is carefully reviewing the Complete Response letter and will seek an expedited meeting with the FDA to discuss its recommendations. Management is pleased to have received specific advice on the remaining issues and is looking forward to making a thorough but expedited response its top priority, and plans to take all appropriate steps to seek approval and commercialization of Ampligen®.


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