Ampio pharmaceuticals, inc. provides updates regarding the continued progress of its phase iii ap-013 clinical trial; provides updates on its manufacturing facility

Ampio pharmaceuticals, inc. announced updates regarding the continued progress of its phase iii ap-013 clinical trial and its manufacturing facility. as of december 3, 2019, of the 1,034 patients to be enrolled in ap-013, more than 700 have been injected and an additional 50 patients have been approved for injection in the near term. as more than 350 patients have now reached the study's 12-week primary endpoint, the clinical trial is more than 33% complete. exclusions from the more than 1,050 consented patients continues to average 29% in order to ensure enrollment of only patients with severe osteoarthritis of the knee who do not have other pain or medical conditions that could interfere with their assessment of the pain and function in the injected knee.the company also announced that it has built a compact, highly efficient and cost-effective, gmp manufacturing facility at its corporate headquarters to enable the company to have direct oversite and control over the ongoing manufacturing and commercial launch of ampion shortly after fda approval of ampion. this facility utilizes sterile, single-use processing disposables in an automated, proprietary process that creates a market advantage with flexible pricing, strong operating margins and capacity to meet global demand. all cmc validation lots for bla submission have been completed and documented.
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