| Ampio Pharmaceuticals announces the FDA has issued a written response and accepted the Ampio plan for beginning production of Ampion(TM) in the new facility. | ENGLEWOOD, Colo., July 30, 2014 /PRNewswire/ -- Ampio Pharmaceuticals, Inc. (NYSE MKT: AMPE) today announced a positive written response from the FDA in regards to the company's plans to begin production of Ampion(TM) in our new drug manufacturing facility.
Dr. Vaughan Clift, Ampio's Chief Regulatory Officer explained, "Satisfying the Chemistry, Manufacturing and Controls (CMC) requirements of a Biological License Application can be one of the most complex elements of the Biologics License approval process and generally requires face-to-face meetings and teleconferences with the FDA to resolve issues. However, based on a review of our submitted proposal to satisfy the CMC requirements, the FDA suggested that the planned face-to-face meeting was no longer necessary, and all minor remaining issues can be resolved by written exchange prior to the BLA filing".
Mr, Macaluso, Ampio's CEO, noted that,"This decision by the FDA was greatly encouraging to our management team as it supports the quality of our efforts to develop and implement a comprehensive plan to manufacture Ampion(TM) in our new facility, fully compliant with all FDA regulations. This plan requires no additional clinical trials to bring our manufacturing facility online. Our Colorado facility will be a show piece as well as a significant asset to the company." |
