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ARTICLE | Clinical News

FDA requests additional trial for Ampio's osteoarthritis therapy Ampion

August 10, 2018 7:24 PM UTC

Ampio Pharmaceuticals Inc. (NYSE-M:AMPE) said FDA requested an additional randomized trial of Ampion to treat severe osteoarthritis (OA) of the knee prior to a BLA submission for the candidate.

According to the company, FDA stated in a letter that while it considers the Phase III AP-003-A trial to be adequate and well controlled, that study alone "does not appear to provide sufficient evidence of effectiveness to support a BLA." The agency did not consider the Phase III AP-003-C trial to be adequate and well controlled, and therefore requested Ampio perform an additional trial to support BLA submission. FDA recommended that Ampio request an SPA for the new trial prior to initiation...

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Ampio Pharmaceuticals Inc.