Hemispherx Biopharma,HEB - Losing Ground
Hemispherx Biopharma, Inc
Rochester, NY 6/05/2009 06:16 PM GMT (TransWorldNews)
Hemispherx Biopharma,HEB - Losing Ground
Hemispherx Biopharma, Inc,HEB
CEO of Hemispherx Biopharma is proported to regularly use an eight year old government report to assure investors the company's chronic fatigue syndrome drug will be approved soon.
The evidence is mounting that Carter is seeking to divert investors' attention away from the delayed approval of Ampligen as a treatment for chronic fatigue syndrome. The U.S. Food and Drug Administration was supposed to announce its decision May 25, but on May 26, Hemispherx said the FDA asked for a "brief delay" of one to two weeks.
Wed, May 27, 2009
The Sage Group, a privately held international health care consulting group, announced recently that HemispherX Biopharma has expanded the mandate for The Sage Group to include, in addition to the strategic partnering efforts related to Ampligen (an experimental immunotherapeutic) for Chronic Fatigue Syndrome, additional partnering efforts related to Ampligen's use to increase the effectiveness of preventative pandemic flu vaccines and the additional role of Alferon LDO (an experimental therapeutic) for treating various types of pandemic flu.
In particular, Sage is assisting HemispherX in its work with the Japanese government in the rapid development of a response strategy for pandemic flu. According to Time Magazine, the number of swine flu cases in Japan are escalating with surprising speed, and health officials are not sure why.
Tue, 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.
Hemispherx Biopharma, Inc., a biopharmaceutical company, engages in the clinical development, manufacture, marketing, and distribution of new drug therapies for the treatment of viral and immune based chronic disorders. The company's products include Alferon N Injection for the treatment of genital warts; and Ampligen, an experimental drug that is in human clinical development for the treatment of myalgic encephalomyelitis/chronic fatigue syndrome, HIV, renal cell carcinoma, and malignant melanoma. Its products also comprise Alferon LDO, a low-dose, oral liquid formulation of natural alpha interferon for influenza and viral diseases, which is in the early stage of development; and Oragens for the treatment of viral diseases and disorders of the immune system. Hemispherx Biopharma, Inc. was founded in 1990 and is headquartered in Philadelphia, Pennsylvania.
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