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Wednesday, August 8, 2018

-=Ampio Pharmaceuticals (AMPE) plunges below $1 threshold after FDA comments on clinical trial



Shares of Ampio Pharmaceuticals (AMPE) plunged more than 70% Wednesady, to fall back below the $1 threshold for the first time in 10 months, after the biopharmaceutical company said the Food and Drug Administration said a current trial for a treatment of osteoarthritis of the knee did not support a biologics license application (BLA). The FDA said the that as a single trial, the AP-003-A trial on its own does not appear to provide sufficient evidence of effectiveness to support a BLA. The FDA recommended an additional randomized trial. "Despite our belief that the APC-003-C trial design was based on FDA guidance and feedback and consistent with FDA precedent for similar products (in intended use, in origin, and in regulatory pathway), which we reiterated with the FDA multiple times, the FDA does not consider the AP-003-C trial to be an adequate and well-controlled clinical trial," Ampio said in a statement filed with the Securities and Exchange Commission. The stock has now lost 79% year to date, while the iShares Nasdaq Biotechnology ETF (IBB) has climbed 10% and the S&P 500 (SPX) has gained 6.8%.

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