Ampio Pharma Gets Feedback From FDA On Its Treatment For Osteoarthritis

(RTTNews) - Ampio Pharmaceuticals Inc. (AMPE) Tuesday said it received feedback from the FDA on its proposed modifications to the special protocol assessment for Ampion treatment of severe Osteoarthritis of the knee.

The AP-013 study is being conducted under a Special Protocol Assessment which provides a documented framework for communication and gaining agreement with the FDA to support a commercial Biologics Licensing Application.

In their feedback, the FDA agrees that OAK is a highly prevalent condition that affects millions of patients in the United States. In addition, the FDA provided practical guidance for the AP-013 study to navigate the pandemic, and to complete the study without re-running the trial.

AMPE is currently trading at $1.70, down $0.26 or 13.27%, on the Nasdaq.