- Ampio Pharmaceuticals Inc's (NYSE:AMPE) independent special Committee of the Ampio Board of Directors has started an internal investigation regarding Ampio's AP-013 trial with the assistance of independent legal counsel.
- FDA has communicated to Ampio that it does not consider data from AP-013 to be sufficient to demonstrate efficacy as a second pivotal trial for Ampion.
- Further analysis suggests that data from AP-013 will not be sufficient to support regulatory approval in the US or other countries.
- Related: Ampio Pharma Shares Fall As FDA Rejects Proposed Change In Knee Osteoarthritis Trial.
- The management's recent analyses also indicate no clinically meaningful treatment effect signals from Ampio's three COVID-19 trials, AP-017, AP-018, or AP-019.
- The Ampio board has also begun a process to consider strategic alternatives for Ampio and Ampion, positioning the Company for a strategic transaction or other alternatives.
- The Committee is overseeing a review of unauthorized use of Ampion by individuals not participating in clinical trials.
- Price Action: AMPE shares are down 7.32% at $0.19 during the market session on the last check Tuesday.
