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Hemispherx Vows To Fight FDA’s Second Rejection Of Ampligen

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

In a “complete response” letter, FDA requested at least one new clinical trial, along with nonclinical studies and numerous data analyses, before approval of the chronic fatigue syndrome drug. Hemispherx continues to assert the existing data support approval and plans an appeal to FDA’s Office of New Drugs.

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