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Berger & Montague, P.C., Files Class Action Against Hemispherx Biopharma, Inc. Extending the End of the Class Period to December 1, 2009, When the Company Announced That the FDA Found No Evidence of Efficacy of Its Drug
Date:12/10/2009

postponements of action on Hemispherx's New Drug Application ("NDA") for Ampligen with the U.S. Food and Drug Administration ("FDA"). Specifically, the defendants portrayed the postponements as due to matters such as FDA staffing issues, while concealing that: (a) the delays were due to the Company's failure to submit a number of reports that had been requested by the FDA and which were necessary before review of the drug could be completed; (b) questions had been raised about the adequacy of data submitted with the NDA to demonstrate the drug's efficacy; and (c) the drug could not be approved unless the FDA waived its requirement for two rodent carcinogenicity studies. When Hemispherx belatedly disclosed this information on November 2, 2009, the price of Hemispherx stock dropped 22% from $1.45 per share, to close at $1.13 per share on November 3, 2009.

Then on December 1, 2009, after the market closed, Hemispherx announced that the FDA had denied the Ampligen NDA. The December 1, 2009 press release stated that the FDA concluded that the Company had not submitted "credible evidence of efficacy of Ampligen," and also lacked required testing for carcinogenicity in animals, which defendants admitted they had asked the FDA to waive. On this news, the price of Hemispherx stock dropped an additional 40% from $1.20 per share, to close at $0.71 per share on December 2, 2009.


For more information about this case, please contact:

Sherrie R. Savett, Esq.
Carole A. Broderick, Esq.
Eric Lechtzin, Esq.
BERGER & MONTAGUE, P.C.
1622 Locust Street
Philadelphia, PA 19103
Telephone: 1-888-891-2289 or 215-875-3000

Berger & Montague, founded in 1970, is a pioneer in class action litigation. The firm's approximately 70 attorneys concentrate their practice in complex litigation including securities fraud and corporate governance, antitrust, civil and human rights, consumer protection and environmental and mass torts, and have recovered several
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SOURCE Berger & Montague, P.C.
Copyright©2009 PR Newswire.
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