Hemispherx Biopharma Reaches Agreement With FDA on Specific Steps to Achieve Complete NDA on Proposed CFS Treatment

PHILADELPHIA, March 6, 2008 (PRIME NEWSWIRE) -- Hemispherx Biopharma, Inc. (AMEX:HEB) announced today that, following its submission of a clarifying amendment on January 9, 2008, to its NDA application and a subsequent face-to-face meeting with the Agency, the number of items necessary to accomplish a complete NDA for filing purposes has been reduced from an original fourteen (14) to five (5). Specifically, for NDA filing purposes, 9/14 of the original incomplete items noted in FDA letter received December 5, 2007 are no longer considered filing-related issues. The remaining open items are being promptly addressed by the Company through a series of five (5) additional Amendments to its NDA as described below.
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