FDA Declines Application for Ampligen

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Thursday, 07 February 2013 00:00 Last Updated on Thursday, 07 February 2013 07:29 Written by Administrator

News - INTERNATIONAL NEWS

Hemispherx Biopharma Receives Complete Response
Letter From FDA on Ampligen(R) New Drug Application for
Chronic Fatigue Syndrome

PHILADELPHIA, Feb. 4, 2013 (GLOBE NEWSWIRE) -- 

Hemispherx Biopharma, Inc.

(NYSE MKT:HEB) (the "Company" or "Hemispherx"), announced that it received a Complete Response Letter from the US Food and Drug Administration ("FDA") declining to approve its new drug application ("NDA") for Ampligen®

for Chronic Fatigue Syndrome ("CFS"). The FDA said Hemispherx should conduct at least one additional clinical trial, complete various nonclinical studies and perform a number of data analyses.

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