Guest guest Posted December 2, 2009 Report Share Posted December 2, 2009 PHILADELPHIA, Dec. 1, 2009 (GLOBE NEWSWIRE) -- Hemispherx Biopharma, Inc. (NYSE Amex:HEB) (the " Company " or " Hemispherx " ), announced that it received a Complete Response Letter from the U.S. 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®. Thursday 10:00 there will be a conference call. This call will be webcast via the Company's website at: http://www.hemispherx.net. Quote Link to comment Share on other sites More sharing options...
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