Expanded Access Policy
What is Expanded Access?
Expanded access, also referred to as compassionate use, is one potential pathway for people with life-threatening diseases to gain early access to an investigational medicine outside of a clinical trial when no satisfactory alternative treatment is available.
At Evergreen Therapeutics, we fully understand and endorse the importance of Expanded Access Programs in certain circumstances. Treating physicians and patients should note that investigational drugs have not established safety and efficacy and have not yet been approved by the U.S. Food and Drug Administration (FDA) for their specific use(s). It is important to carefully evaluate all potential risks and benefits before seeking expanded access to investigational drugs.
FDA considerations for Expanded Access eligibility
The FDA generally considers whether all of the following criteria are met when evaluating Expanded Access requests:
- The patient has a serious or immediately life-threatening disease or condition.
- There is no comparable or satisfactory alternative therapy to diagnose, monitor, or treat the disease or condition.
- Patient enrollment in a clinical trial is not possible.
- The potential patient benefits justify the potential risks of treatment.
- Providing the investigational product will not interfere with ongoing clinical trials that could support development or marketing approval for the treatment indication.
At this stage in our clinical development, Evergreen does not offer an Expanded Access Program for its investigational medicines. We encourage patients to discuss potential participation in clinical trials with their treating physicians. For information about clinical trials conducted by Evergreen, please visit https://clinicaltrials.gov.
In line with the 21st Century Cures Act, Evergreen Therapeutics may revise this policy at any time. Should expanded access become appropriate in the future, this web page will be updated accordingly, and information on how to apply for expanded access will be provided.
For questions regarding Evergreen’s Expanded Access Policy, please contact: medical@egmedai.com. We anticipate acknowledging receipt of requests for information sent to this email within 5 business days.
Effective Date: 09/14/2026