Expanded Access Policy
Last Updated: January 23, 2024
This document reflects Elicio’s position and corporate policy on a potential pathway to gain access to an investigational medical product when no comparable or alternative therapy options are available for seriously ill patients who are not eligible for our clinical trials. Such access is sometimes referred to as “expanded access” or “compassionate use.” In these circumstances, Elicio will consider providing a requesting physician with pre-approval access to a specific Elicio investigational product, for the treatment of an individual patient outside of a clinical trial, when certain conditions are met. These conditions include the following:
- Patient has a serious or immediately life-threatening disease or condition, and there is no comparable or satisfactory alternative therapy to diagnose, monitor, or treat the disease or condition.
- Potential patient benefit justifies the potential risks of treatment, and the potential risks of treatment are not greater than the risk of the disease or condition to be treated.
- Patient is ineligible for, or otherwise unable to, participate in a clinical trial for the investigational product.
- Providing the investigational medical product will not negatively impact broader patient access by delaying or interfering with the conduct of clinical trials that could support the development, regulatory review, or marketing approval of the investigational product.
- A licensed physician is responsible for treating the patient with the investigational product.
- FDA and all other legal and regulatory requirements have been met.