TJG Wednesday, 11/25/20 09:19:16 AM Re: None Post # of 1282 Nebulizer trial continues to move forward as progress is positive from the 3 safety trials. Ampio Updates Regulatory and Clinical Trial Events 9:15 AM ET 11/25/20 | Dow Jones ENGLEWOOD, Colo., Nov. 25, 2020 /PRNewswire/ -- Ampio Pharmaceuticals, Inc. (NYSE American: AMPE), a biopharmaceutical company focused on the advancement of immunology-based therapies for prevalent inflammatory conditions, announced today the following updates: -- Patients experiencing respiratory distress due to COVID-19: In the Phase I inhaled Ampion(TM) clinical trial (AP-014), the third of three initial safety groups of patients have completed their five days of treatment and three days of follow up for Safety Monitoring Committee (SMC) review (as inhalation is a new delivery method of Ampion cleared for clinical use by the FDA). Once the SMC provides confirmation regarding no safety concerns for this third group, the trial will accelerate to complete the remaining thirty-four patients at the speed of recruitment with additional hospital groups added as required to support enrollment. -- Patients with severe osteoarthritis of the knee (OAK): The amendment to the OAK Phase III clinical trial (AP-013), that harmonizes the FDA agreement on the Special Protocol Assessment (SPA) with FDA guidance for clinical trials on hold due to COVID-19, has been received by the FDA. The FDA notified the Company that a formal response will be provided by the end of this year.