We are committed to developing new medicines to transform the lives of patients with life-altering brain health disorders. As part of this mission, we conduct clinical trials to determine if our investigational medicines are safe and effective for patients with a particular disease, disorder or condition which may allow us to seek the necessary regulatory approvals to provide wide access to these medicines.
We understand that, in some cases, patients with serious diseases or conditions may not be eligible for clinical trials and may not have other treatment options. Under very limited circumstances, we will consider making investigational medicines available for qualifying patients to treat a serious disease or condition outside of a clinical trial prior to regulatory approval. This type of access is often referred to as "early access," "expanded access" or "compassionate use".
Our differentiated approach to drug discovery and development has allowed us to create a broad portfolio of fully-owned product candidates with the potential for development in a wide range of psychiatric, neurological and related central nervous system (CNS) disorders.