Hemispherx Biopharma's Ampligen NDA for Chronic Fatigue Syndrome

Stocks mentioned in this article PHILADELPHIA, July 8, 2008 (PRIME NEWSWIRE) -- Hemispherx Biopharma, Inc. (AMEX:HEB) today reported that the U.S. Food and Drug Administration (FDA) has accepted for review the Company's New Drug Application (NDA) for Ampligen(r), an experimental therapeutic, to treat Chronic Fatigue Syndrome (CFS), originally submitted in October 2007. Hemispherx is seeking marketing approval for the first-ever treatment for CFS. At present, only supportive, symptom-based care is available for CFS patients. The NDA for Ampligen(r), whose chemical designation is poly I : poly C12U, is also the first ever accepted for review by the FDA for systemic use of a toll-like receptor (TLR) therapy to treat any condition. CFS is estimated to afflict approximately 4 million Americans according to the Centers for Disease... [read full story]