At CymaBay, we are committed to improving the lives of patients with liver and other chronic diseases by developing and providing access to safe, effective, and innovative therapies. For those patients with serious or life-threatening diseases that our investigational medicines may treat, we understand there may exist an urgent need for new treatment options prior to formal approval by regulatory health agencies. While we believe the best way for patients to access investigational medicines is through clinical trials, we also believe in supporting expanded access and compassionate use programs when and if it is appropriate to do so. This is at the core of our commitment to patients and healthcare providers.
CymaBay will consider compassionate use access to its investigational medicines outside of a clinical trial when all the following criteria are met:
Requests for access to investigation medicines must be made by a qualified and licensed physician through CymaBay Medical Information at firstname.lastname@example.org.
CymaBay will acknowledge such requests within approximately 5 business days of receipt of the request. All eligible requests will be evaluated by a review committee in a fair, unbiased manner.
Information about CymaBay clinical trials can be found here. This policy is not a guarantee of access to any CymaBay investigational medicine. CymaBay reserves the right to revise or revoke this policy at any time.