pharmiweb.co.uk
08-Jul-2008
said Tuesday the Food and Drug Administration has accepted for review the company's new drug application for Ampligen, an experimental chronic fatigue syndrome treatment. The Philadelphia biotechnology company has been developing Ampligen for more than three decades. Initially, the drug was tested as a potential treatment for cancer and later for AIDS. Hemispherx (AMEX:HEB) originally submitted an NDA for the compound in last October. The FDA raised numerous questions about the application and the supporting clinical trial, which the company had to resolve before the FDA would accept the application. Chronic fatigue syndrome afflicts an estimated 4 million Americans, according to the Centers for Disease Control and...
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