** DUE TO LIMITED SUPPLY OF BERUBICIN, WE ARE CURRENTLY UNABLE TO CONSIDER COMPASSIONATE USE (ALSO KNOWN AS EXPANDED ACCESS) REQUESTS. WE ARE ADDRESSING THIS ISSUE AS RAPIDLY AS POSSIBLE TO BEGIN OFFERING BERUBICIN UNDER THIS POLICY. **
CNS Pharmaceuticals, Inc (“CNS”) is committed to developing novel treatments for brain tumors designed to address significant unmet medical need.
CNS is focused on bringing our lead drug candidate, Berubicin, to the patients who need treatment via clinical trials. We understand that there are patients who will not fit the clinical trial eligibility criteria and thus not be able to participate in our clinical trials or clinical trials being conducted by other pharmaceutical/biotech companies. Under these special circumstances, CNS 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 of 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 will consider the request; however, CNS 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; CNS 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 whose decisions are final.
Physicians seeking pre-approval access for patients with no alternative treatment options should submit their requests to: [email protected]
CNS will use all best efforts to acknowledge each submitted request within 7 business days after receipt.