Hemispherx Ampligen chronic fatigue NDA in Q4
This article was originally published in Pharmaceutical Approvals Monthly
Hemispherx plans to submit an NDA in the fourth quarter for its chronic fatigue syndrome agent Ampligen, the firm says. The company originally had planned a 2004 submission, but was delayed by manufacturing complications and safety issues. While Ampligen has been in development for over a decade, Hemispherx believes the double-stranded RNA drug could be viewed positively at FDA in light of recent findings on chronic fatigue from the Centers for Disease Control & Prevention, which it believes will validate an unmet need for the experimental immunostimulant...
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