Expanded Access Policy

Before our therapies currently in development are fully reviewed and approved by regulatory authorities (including the U.S. Food and Drug Administration (FDA)), they can be accessed only through participation in our clinical trials. Clinical trials are controlled research studies designed to evaluate whether a new therapy is safe and effective for patients, and they provide the most direct opportunity for patients to access a new product before regulatory approval. While we are very mindful of the serious impact that neurological diseases such as Alzheimer’s disease and Parkinson’s disease have on those affected, and are committed to completing the regulatory review and approval process as diligently as possible through our ongoing clinical trials, we are not currently in a position to offer access to our therapies in development outside of these trials, either through what is known as “expanded access” or otherwise.

What is “expanded access”? Expanded access, also known as “compassionate use,” is a process by which a limited number of qualifying patients may be granted access to an investigational product on a case-by-case basis. Requests for expanded access must be initiated by a treating physician and generally apply to patients who do not qualify for clinical trials, have exhausted all available treatment options, and have an immediately life-threatening condition or serious disease or condition, among other criteria. You can learn more about expanded access by visiting the FDA website at: Expanded Access | Information for Patients