HEB Hemispherx Biopharma Announces Possible Brief Delay in FDA Action

shyla

http://money.aol.com/news/articles/_a/hemispherx-biopharma-announces-possible/rfid217064570

PHILADELPHIA, May 26, 2009 (GLOBE NEWSWIRE) -- 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.

RGS

oh~ thanks~

zhao

wustler

From this PR I think HEB could receive a response at any time from now on:

"...it may require up to 1-2 additional weeks...the possible delay was attributed by the Agency to certain staff scheduling changes which might (or might not) delay the report...

shyla

4# wustler


‘’My imaginary GF told me that FDA asked for extension because they felt
sorry for us the investors over the past two weeks since the stock did
not realize its full potential in anticipation of the approval because
of Dr. Dilution. So, they decided to give us investors a chance by
extending 1-2 more weeks so we can build the momentum again. ‘’

http://finance.google.com/group/ ... d/b054fef653bcdd37#