Hemispherx Files Complete Response With FDA For Ampligen NDA - Quick Facts

(RTTNews.com) - Hemispherx Biopharma Inc. ( HEB ) filed its complete response with the U.S. Food and Drug Administration to the FDA'sNovember 25, 2009 Complete Response Letter for Ampligen's New Drug Application or NDA for Chronic Fatigue Syndrome or "CFS". Hemispherx entered into an agreement on the filing requirements for the company's complete response, as reported earlier. The FDA has indicated that the new submission would be reviewed on a 6 month cycle. The Ampligen data were organized and filed with the FDA 53 days after the June 8, 2012 meeting with the Agency.

At present, no drug has received FDA approval to treat CFS, a chronic, seriously debilitating disease.

The FDA has agreed to accept, for review, further analyses of data from Hemispherx's AMP-516 Phase III trial and other Ampligen studies in lieu of the additional confirmatory Phase III trial originally called for in the Agency's CRL. Whether these data provide adequate evidence of efficacy will ultimately be a review issue, and there can be no assurance the FDA would conclude the data are adequate to support approval of the Ampligen New Drug Application or "NDA".

Hemispherx believes that the data and analyses provided in its complete response may be relevant to the potential for approval of Ampligen under this expanded statutory authority.