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Keyword: ampligen

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  • Panel rejects experimental chronic fatigue syndrome drug

    12/23/2012 9:17:26 PM PST · by Seizethecarp · 9 replies
    Nature ^ | December 21, 2012 | Heidi Ledford
    A drug for chronic fatigue syndrome that spent decades in clinical development and won fervent patient support has been turned down for approval by a committee of advisers to the US Food and Drug Administration (FDA) who voted 9–4 against it. The drug, named Ampligen (rintatolimod), has not been shown to be effective or safe, the committee determined on 20 December. “Key deficiencies included inadequate evidence of effectiveness or safety, inadequacy of drug–drug interaction studies, lack of carcinogenicity assessment, lack of anti-drug antibody determination, and inadequate analytical methods and drug product specifications,” the agency wrote in one of several sections...