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FDA requires additional study of Ampio Pharma's Ampion to support marketing application; shares down 11% premarket

Dec. 13, 2018 7:10 AM ETAmpio Pharmaceuticals, Inc. (AMPE) StockBy: Douglas W. House, SA News Editor1 Comment
  • Ampio Pharmaceuticals (NYSE:AMPE) is down 11% premarket on the heels of its announcement that the FDA will require a new clinical trial evaluating lead candidate Ampion in patients with knee osteoarthritis to support a marketing application.
  • The company intends to file its Special Protocol Assessment (SPA) for the 150-subject study in the near future. Its design will allow for the expansion of enrollment to 300 if necessary.

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