Hemispherx Biopharma's Ampligen NDA for Chronic Fatigue Syndrome Accepted for Review by the FDA

Tuesday July 8, 9:45 am ET Marks the First Drug Candidate for Approval to Treat CFS, and the First Compound in the TLR Class PHILADELPHIA, July 8, 2008 (PRIME NEWSWIRE) -- Hemispherx Biopharma, Inc. (AMEX:HEB - News ) 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.... [read full story]