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POLICY ON EXPANDED ACCESS TO INVESTIGATIONAL DRUGS
Denali understands that there are some cases when a patient is unable to participate in a clinical trial, and other treatment options have been exhausted. In those cases, the patient's physician may choose to request access to an investigational drug outside of a clinical trial via what is termed Expanded Access in the United States.
Currently, participation in clinical trials is the only way for patients to gain access to Denali's investigational therapies. As more clinical data on the safety and efficacy of these investigational therapies become available, we will review and update our policy on Expanded Access.