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>
Here is what MAPS (the organization running the Phase 3 trials of MDMA-assisted psychotherapy and the same organization that applied for expanded access) has to say about this: [1]<p>Donate to MAPS, people, if you believe in this!<p>[1] - <a href="https://maps.org/news/media/8008-press-release-fda-agrees-to-expanded-access-program-for-mdma-assisted-psychotherapy-for-ptsd" rel="nofollow">https://maps.org/news/media/8008-press-release-fda-agrees-to...</a>
There's an entire industry of psyche meds already. And they all have 'trials' proving their efficacy. Do those pills not work? Is it all a sham?