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FDA Decision on Ampligen® as Treatment for ME/CFS Delayed Beyond May 25 Target Date

  [ Not Yet Rated ]   [ Discuss This Article ] • 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(r) (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(r) continues as described in the recently filed 10Q and 10K, as the FDA did not request additional information from the Company at this time.
Source: Hemispherx Biopharma news release, May 26, 2009

[Note: an earlier HB release dated April 27 indicated the Japanese National Institute of Infectious Diseases has reported on preclinical trials of Ampligen for treatment of the H1N1 flu virus and may extend the program to human volunteers.]

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