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Hemispherx Biopharma, Inc. Message Board

  • helterskelterheb helterskelterheb Jun 7, 2013 2:03 PM Flag

    FDA's Ampligen Letter

    "For many years FDA has worked with Hemispherx Biopharma, Inc. (Hemispherx) on an approval pathway for Ampligen. Since the time of the original New Drug Application (NDA) submitted by Hemispherx for the use of Ampligen to treat CFS in 2007, FDA’s review division has provided many specific recommendations on how best to address deficiencies in the application. In 2009, the review division asked Hemispherx to conduct at least one additional controlled clinical study showing a convincing effect in the CFS population. No new trials were conducted. Hemispherx conducted additional analyses of their existing data, which FDA agreed to review in a resubmitted NDA.

    A public meeting of FDA’s Arthritis Advisory Committee (AC) on December 20, 2012, was held to provide FDA with independent scientific and clinical expertise regarding the Ampligen NDA. At the meeting, both Hemispherx and FDA reviewers presented assessments and analyses of the NDA data to the experts, including physicians with expertise in CFS, a CFS patient representative, and an industry representative. The majority of AC members were concerned about the lack of consistency within the clinical trial results, as well as the limited size of the database available to evaluate Ampligen. The members shared FDA’s concerns, as well, about how the studies had been conducted, including multiple discrepancies and gaps in the safety data. At the end of a full day of discussion AC members voted 8-5 against the approval of Ampligen for the treatment of patients with CFS because of insufficient safety and efficacy data."

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    • The FDA just does not understand the power or TLR3 science....


    • Yep. Carter won't do the addtional trial because WHEN it would fail, so would his "hope pumping" stock selling machine that keeps him in is million dollar + a year job. The company still has 30 million shares to sell in the maxum agreement. Not to mention he is getting up in the years and HEB has enough current cash keep the stock selling machine running for another couple of years without having to do ANYTHING. The latest "coverage" HEB has been getting I'm sure Carter paid for and I'm also sure they dumping those remaining 30 million shares as we speak as I'm sure he is planning his retirement and how to keep this scam going for a little longer.

      American Greed at it's finest.

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