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Tuesday, May 26, 2009

Hemispherx HEB FDA Delay News May 2009

Hemispherx Biopharma, Inc. (HEB) stock is very active this morning, 5/26/09, as the company has issued the following press release:

HEB Stock News - May 26, 2009

HEMISPHERX BIOPHARMA ANNOUNCES POSSIBLE BRIEF DELAY IN FDA ACTION ON AMPLIGEN® NEW DRUG APPLICATION

Philadelphia, PA, Tuesday, May 26, 2009: Hemispherx Biopharma, Inc. (NYSE/AMEX -HEB) today announced that the U.S. Food and Drug administration (“FDA”) has advised the company that it may require up to 1-2 additional weeks to take action beyond the scheduled Prescription Drug User Fee Act action date of May 25, 2009 on the New Drug Application for Ampligen® (Poly I Poly C12U), a selective TLR3 modulator, for the management of Chronic Fatigue Syndrome. Reason for the possible delay was attributed by the Agency to certain staff scheduling changes which might (or might not) delay the report. Accordingly the Company’s development plan for Ampligen® continues as described in the recently filed 10Q and 10K, as the FDA did not request additional information from the Company at this time.

http://www.hemispherx.net/content/investor/default.asp?goto=631

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