Hemispherx Biopharma, Inc. (AMEX Symbol: HEB) (Price: $7.25) confirmed that it had an “exchange of communications” with the U.S. Food and Drug Administration (“FDA”) a week prior to its 6:00 P.M. EST, Friday, October 23, 1998 disclosure. This confirms that Hemispherx’s earlier claim that it has received the Notice of Infraction on October 22, 1998 was false. Hemispherx received notice of the FDA’s determination that Hemispherx had violated Federal law by promoting Ampligen as a safe and effective drug prior to its approval for marketing no later than October 15, 1998.
Hemispherx failed to disclose and then distorted the facts surrounding its FDA Notice of Infraction. Hemispherx has violated the law by claiming Ampligen is a safe and effective drug and violated the law by claiming its CFS Phase II study showed efficacy and safety. None of Hemispherx’s claims concerning Ampligen’s safety and efficacy or the results of the Phase II CFS trials have been approved by the FDA. Any information to the contrary released by Hemispherx is merely another example of its intent to defraud investors.
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