Expanded Access/Compassionate Use Policy

Scope

This policy applies to expanded access and compassionate use requests for our investigational product that has not been approved for any purpose in any country. For purposes of this policy, an expanded access or compassionate use request is any request for the use of our investigational product outside the scope of a clinical study.

Policy

Ampio’s development resources are focused on conducting clinical studies and obtaining regulatory approval of our investigational product. Ampio does not have an Expanded Access Program at this time and is not accepting or considering requests for expanded access and/or compassionate use requests. Should an Expanded Access Program be developed, this policy statement will be updated.

Updated December 2021