Expanded Access Program

We understand that there are patients who will not fit the clinical trial eligibility criteria and thus not be able to participate in clinical trials. Under these special circumstances, CNS Pharmaceuticals may consider providing a requesting physician with compassionate use (also referred to by the FDA as “expanded access”) for the treatment of an individual patient outside of a clinical trial where the patient has a serious or life-threatening illness or condition, and all the following criteria are met:

• Patient has a serious disease or condition, or whose life is immediately threatened by their 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.
• Potential patient benefit justifies the potential risks of treatment.
• Providing the investigational medical product will not interfere with investigational trials that could support a medical product’s development or marketing approval for the treatment indication.
• Treating physician accepts responsibility for the regulatory qualification and reporting requirements determined by the FDA.

If all these conditions are met, CNS Pharmaceuticals will consider the request; however, we cannot make a guarantee that such access will be available or offered. Requests will be considered on a case-by-case basis.

All requests must be submitted by the patient’s treating physician; we may require more detailed information to fully evaluate a request. The requesting physician must agree to obtain appropriate regulatory and institutional review board/ethics committee approvals and comply with regulatory obligations, including obtaining patient consent, patient monitoring and safety reporting. Each request will be given careful consideration by CNS Pharmaceuticals whose decisions are final.