Shares of Ampio Pharmaceuticals (NYSEMKT: AMPE) were tanking by 18.6% as of 3:42 p.m. EST on Tuesday. The big drop came after the company announced that it had received feedback from the U.S. Food and Drug Administration (FDA) on proposed modifications to the special protocol assessment (SPA) for its AP-013 late-stage study of Ampion in treating severe osteoarthritis of the knee.
Under the FDA's SPA process, companies are allowed to discuss the designs of clinical trials with the FDA to ensure that they meet all of the criteria to support regulatory approval. Ampio stated that the FDA provided guidance that gives the company options allowing it to complete its late-stage study of Ampion without rerunning the trial.
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Why Ampio Pharmaceuticals Stock Tanked Today