HEB: No FDA Approval for Ampligen

December 1, 2009 - The FDA has finally come out and decided on CFS Drug, Ampligen

The Ruling? No

Shares of Hemispherx Biopharma, Inc. (HEB) are trading in the $0.70's tonight in afterhours in the wake of this news.

This doesn't appear over quite yet as Hemispherx Biopharma, Inc. is requesting a meeting with the FDA.


Link


Hemispherx Biopharma Receives Complete Response Letter from FDA on Ampligen® New Drug Application for Chronic Fatigue Syndrome

Hemispherx Biopharma, Inc. (NYSE Amex: HEB) (the “Company” or “Hemispherx”), announced that it received a Complete Response Letter from the US Food and Drug Administration (“FDA”) which describes specific additional recommendations related to the Ampligen® NDA. In accordance with its 2008 “Complete Response” procedure, the FDA reviewers determined that they cannot approve the application in its present form and provided specific recommendations to address the outstanding issues. Hemispherx is carefully reviewing the Complete Response letter and will seek an expedited meeting with the FDA to discuss its recommendations. Management is pleased to have received specific advice on the remaining issues and is looking forward to making a thorough but expedited response its top priority, and plans to take all appropriate steps to seek approval and commercialization of Ampligen®.


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Hemispherx HEB Conference Call 7/22/09 - July 22, 2009

Hemispherx Biopharma, Inc. (HEB) stock is breaking out today, $2.92 Up 17.50%, one day before a conference call to update shareholders on influenza prevention. HEB is breaking out above the previous June 2009 high of $2.85 which is bullish.

Ampligen: HEB is also waiting for an FDA decision on their CFS drug Ampligen. Investors and Traders could be getting in with anticipation that we will hear an positive update on Ampligen. After seeing what happened to Human Genome Sciences Inc. (HGSI), an FDA approval for Ampligen could be explosive for HEB.

Update - 7/22/09 - " Still Waiting on Response from FDA on Ampligen "

HEMISPHERX BIOPHARMA TO PROVIDE UPDATE ON GLOBAL PANDEMIC INFLUENZA PREVENTION / TREATMENT INITIATIVES

Philadelphia, PA, Monday, July 20, 2009: Hemispherx Biopharma (NYSE AMEX: HEB) will provide an update on its Influenza research initiatives via teleconference on Wednesday, July 22, 2009, at 10:00 AM EDT. Initiatives to be discussed will include experimental programs planned or underway in Pacific Rim countries, Australia, South America and the United States. Background information may be sourced at Wall Street Journal, July 18/19, 2009, p. A3.

Hemispherx’s Medical Director, CEO, and the Managing Director of the Sage Group, a health care consulting firm retained by Hemispherx, will participate. Investigational products and protocols to be discussed will include Hemispherx’s Ampligen® (poly I: poly C12U), Alferon N (a natural cocktail of alpha 2 type interferons, FDA approved for treatment of refractory HPV) and Alferon LDO, an experimental formulation of Alferon-N for oral delivery. Full Article

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Hemispherx HEB Stock Rising! 6/2/09

Hemispherx Biopharma, Inc. (HEB) stock is soaring this afternoon ( June 2, 2009 ) on absolutely no news but anticipation for approval of their drug Ampligen. We have been discussing HEB since the stock was in the low $1's and many people are making a lot of money today. The FDA decision could make or break this stock in the next week.

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Below is the latest HEB news as of 6/2/09:

Hemispherx Biopharma Announces Possible Brief Delay in FDA Action On Ampligen(r) New Drug Application

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.

http://finance.yahoo.com/news/Hemispherx-Biopharma-pz-15344715.html?.v=2


Hemispherx Biopharma Presents Influenza Prevention / Treatment Platform at International Conference in Rome under Auspices of Italian Government

June 1, 2009 (GLOBE NEWSWIRE) -- Hemispherx Biopharma (NYSE Amex:HEB) announced today an invitation, funded entirely by the government of Italy, to present its technology platform for influenza control, at the upcoming "International Conference on Biotechnologies and Finance" in Rome on July 4-5, 2009, at the Sheraton Parco de Medici. According to the Conference Organizers, leaders of "private and public research centers, intellectual property holders and financial experts from Europe, Australia, Canada, Estonia, Singapore and the USA" will participate. Hemispherx will present in a Round Table Discussion on Pandemic Influenza, moderated by Dr. Elemer Piros, Senior Pharmaceutical Analyst at Rodman and Renshaw, a USA investment bank.

http://finance.yahoo.com/news/Hemispherx-Biopharma-Presents-pz-15398718.html?.v=1

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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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