Overview
Expanded access is a potential pathway for a patient with a serious or immediately life-threatening disease or condition to gain access to an investigational medical drug, biologic, or device for treatment outside of clinical trials when no comparable or satisfactory alternative therapy options are available. It is also known as ‘compassionate use.’
Investigational drugs, biologics or medical devices have not yet been approved or cleared by the FDA, and the FDA has not found these products to be safe and effective for their specific use. Furthermore, the investigational medical product may or may not be effective in the treatment of the condition, and use of the product may cause unexpected serious side effects.
Information regarding Perspective Therapeutics’ ongoing clinical studies can be found on ClinicalTrials.gov using this link.
Criteria for Expanded Access
Perspective Therapeutics may grant expanded access in response to a written request from a licensed treating physician when all the following criteria are met.
- The patient has a serious or immediately life-threatening disease or condition.
- There is no comparable or satisfactory alternative therapy for the disease or condition.
- Patient enrollment in a clinical trial is not possible.
- Potential patient benefit justifies the potential risks of treatment.
- The treating physician and their institution have adequate training, facilities, equipment, and personnel to administer the investigational product.
- Perspective Therapeutics has an adequate supply of the investigational product and the provision of such will not interfere with investigational trials’ objectives.
- There is a legal and regulatory framework in the country or region that permits and supports expanded access/compassionate use of investigational products, and Perspective Therapeutics has the resources and abilities to provide investigational product to such country or region.