Criteria for Considering Requests for Expanded Access
- The patient has a serious or immediately life-threatening disease or condition.
- There is no comparable or satisfactory alternative treatment for the disease or condition.
- Sufficient clinical evidence of safety and effectiveness in the indication has been established and the potential benefit justifies the potential risks. In this context, the investigational product would have generally completed Phase 2 clinical studies.
- The product is under active development in the indication and expanded access will not interfere with the development of the product.
- KalVista has adequate supply of the investigational product.
- There is a regulatory mechanism in the country or region to support expanded access.
Process for Requesting Expanded Access
Patients interested in seeking expanded access to a KalVista investigational product should talk to their physician. A treating physician may request information about applying for access to one of KalVista’s investigational products by email at email@example.com. KalVista will aim to acknowledge receipt of a request for expanded access within five business days.
All physicians who receive any of KalVista’s investigational products through expanded access are required to comply with all applicable laws and regulations, and contractual conditions, including those relating to safety reporting.