Title is a little unclear, this is for an "Expanded Access Program", for individuals who are unable to participate in a clinical stage 3 trial. [1]<p>"Sometimes called “compassionate use”, expanded access is a potential pathway for a patient with an immediately life-threatening condition or serious disease or condition to gain access to an investigational medical product (drug, biologic, or medical device) for treatment outside of clinical trials when no comparable or satisfactory alternative therapy options are available. "<p>[1] <a href="https://www.fda.gov/news-events/public-health-focus/expanded-access" rel="nofollow">https://www.fda.gov/news-events/public-health-focus/expanded...</a>