Hemispherx files response to FDA for Ampligen treatment of Chronic Fatigue Syndrome

Hemispherx Biopharma filed its complete response to the FDA�s November 25, 2009 Complete Response Letter in support of the New Drug Application for Ampligen for Chronic Fatigue Syndrome (�CFS�). As previously reported, at a recent meeting with the Agency, Hemispherx reached agreement on the filing. The FDA has indicated that the new submission will 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.