WASHINGTON (dpa-AFX) - Hemispherx Biopharma Inc. (HEB) announced that the Food and Drug Administration granted an extension for the Company to modify its New Drug Application or 'NDA' in response to a Complete Response Letter or 'CRL' received November 25, 2009 for the Chronic Fatigue Syndrome or 'CFS' therapeutic indication. The extension will remain open while Hemispherx submits an amended NDA.
In year 2011, a team of researchers at the Centers for Disease Control and Harvard University reported new data on the magnitude of medical and economic impact of untreated CFS.
According to the study, 'CFS patients, their families, employers and society bear significant costs associated with the illness. The symptoms characterizing CFS are common to many illnesses, hence diagnosis is complex... and requiring extensive diagnostic testing and clinical assessment.'
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