Ampio Pharma (AMPE) Says It Met FDA to Seek Guidance on Best Path Forward for Ampion
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Ampio Pharmaceuticals, Inc. (NYSE: AMPE) announced the Company has met with the CBER Division of the FDA to seek guidance on the best path forward to obtain a Biological License for Ampion™ to treat patients suffering from pain caused by severe osteoarthritis of the knee (OAK).
Michael Macaluso, Ampio's CEO noted, "We are grateful to CBER for their thorough review of our data, which referenced over 1800 patients across multiple trials. We appreciate their thoughtful and helpful guidance. CBER's guidance included a number of very good options and as a result, we are continuing discussions. As soon as we have further information we will update our shareholders."
Mr. Macaluso also reported completion of enrollment for AP-011, a Study to Evaluate the Safety of a Single Intra-Articular Injection of Ampion™ for Arthritis of the Basal Thumb Joint. https://clinicaltrials.gov/ct2/show/NCT02762760?term=Ampio&rank=1"The purpose of this initial 'hand' study was to ensure that Ampion™ would be well tolerated (safe) when injected into a small joint at the base of the thumb. OA in the basal thumb joint is common, troublesome, and has limited treatment options. We expect to release further information as soon as all patients have completed the trial."
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