Which patients qualify for Expanded Access?

Qualifications for Expanded Access

(as per federal regulations, CFR Title 21):

1. Patient has a serious disease or condition, or whose life is immediately threatened by their disease or condition;
2. Patient has no comparable or satisfactory alternative therapy to diagnose, monitor, or treat the their disease or condition;
3. Patient enrollment in a clinical trial is not possible;
4. Potential patient benefit justifies the potential risks or treatment;
5. Providing the investigational medical product will not interfere with clinical trials that could support a medical product’s development or marketing approval for the treatment indication.