At Recursion Pharmaceuticals, we are committed to radically improving the lives of patients and their families by developing therapies that will make a lasting, positive, and transformative impact on diseases and conditions for which there are high unmet needs.
We believe that the best way to succeed in our mission is through well-designed clinical trials that determine the safety and effectiveness of investigational medicines. We understand that in some rare and specific circumstances, when enrollment into a clinical trial is not possible, physicians caring for patients with serious or life-threatening conditions or diseases may seek special access to investigational medicines. When appropriate and through an expanded access protocol, Recursion will consider individual Expanded Access, sometimes called “Compassionate Use” or “Early Access”, requests for an investigational medicine outside of an ongoing clinical trial for the indication being investigated by the company.
There may be additional requirements, but to start, a licensed treating physician must submit the request for Expanded Access in writing by contacting ExpandedAccess@Recursion.com. The physician must be able and willing to obtain a treatment IND, or regional equivalent, and Institutional Review Board or Ethics Committee approval, for the patient prior to initiating treatment with our investigational medicine.
We will consider applications to provide the investigational drug that will not, among other things, compromise the scientific validity of our broader development programs, or interfere with or delay clinical trials or regulatory filings designed to make the drug available to a larger patient population.
We endeavor to respond to Expanded Access requests within one week after the steps for submission are completed.
It is important to remember that investigational medicinal products have not yet received regulatory approval; thus, their potential risks and benefits are not yet established. Physicians and patients should consider all possible benefits and risks when seeking access to an investigational medicinal product. For information on available clinical trials visit: www.ClinicalTrials.gov.
cts have not yet received regulatory approval;
thus, their potential risks and benefits are not yet established. Physicians and patients should consider all
possible benefits and risks when seeking access to an investigational medicinal product. For information on
available clinical trials visit: