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Hemispherx Biopharma, Inc. Message Board

  • northtick northtick Jul 14, 2009 5:14 AM Flag

    HEB FDA FORM 483 violations

    THERE WILL BE NO APPROVAL COMING ANY TIME SOON:


    The New Jersey District Office of the FDA conducted an inspection of the New Brunswick, New Jersey facility in late January and early February 2009. A one-page Form FDA 483 was issued citing a need to reperform four method validations to generate data in the New Brunswick Laboratories. These validations had been performed at another site also owned and operated by us prior to transferring the equipment to New Brunswick. The validations have been completed and the reports were forward to the FDA on April 28, 2009 for review.

    The FDA conducted a field inspection at Hollister-Stier Laboratories in Spokane, Washington in mid-2008. The Ampligen� final fill operations are performed under contract with Hollister-Stier. The inspection resulted in a FDA Form 483 with two observations dealing with reviews and validations of process variability. We continue to work with Hollister-Stier to finalize specific actions to address the FDA Form 483 issues and Hollister-Stier has submitted a specific action plan to the Seattle, Washington office of the FDA.

    On September 19, 2008, we executed an agreement with Lovelace Respiratory Research Institute in Albuquerque, New Mexico to perform certain animal toxic studies in support of our Ampligen� NDA. These studies were requested by the FDA and will be done in collaboration with the resources of the New Brunswick facility. We expect these studies to be complete in mid- 2009.

    We are also engaged in ongoing, experimental studies assessing the efficacy of Ampligen�, Alferon N Injection�, and Alferon� LDO against influenza viruses as a single adjuvant agent antiviral with Japan's National Institute of Infectious disease, Biken (the non-profit operational arm of the Foundation for Microbial Diseases of Osaka University) and St. Vincent's Hospital in Darlinghurst, Australia. As a result of focusing our limited resources on the Australian and Japanese studies, no further experiments have been undertaken by the Defence R&D Canada with respect to their independent study assessing the efficacy of Ampligen� against Influenza viruses as a single agent antiviral

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