TheStreet.com reported on this apparent discrepancy between the FDA’s comment and the Company’s repeated representations that the FDA had “agreed to accept” the post-hoc data analyses proposed by the Company in lieu of an additional clinical trial, asserting that: “Hemispherx Biopharma (HEB) lied to investors and to the Securities and Exchange Commission by failing to disclose serious concerns raised by the U.S. Food and Drug Administration about its chronic fatigue syndrome drug Ampligen.” The price of Hemispherx shares fell from $0.64 to $0.37 on December 18.On Monday, February 4, 2013, Hemispherx announced the receipt of a Complete Response letter from the FDA regarding Ampligen, which conveyed that the FDA’s review of the Ampligen application was complete and that it would not approve the application in its present form.
Cohen Milstein Sellers & Toll PLLC Continues To Investigate Hemispherx Biopharma, Inc. Following The FDA’s Rejection Of The Ampligen New Drug Application
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