Expanded Access Policy
Catalyst Biosciences is committed to developing essential medicines to transform the lives of patients with hemophilia and other rare bleeding disorders.
At present, our therapies are considered investigational, which means that they have not been approved by any health authority, such as the Food and Drug Administration in the United States.
To secure health authority approval, we are focusing our development efforts on the conduct of clinical trials designed to answer specific questions about the safety and effectiveness of our therapeutics. It is our belief that this will have the greatest potential to address the needs of the patients whom they are intended to help. Whenever possible, we encourage patients to participate in our clinical trials to help us answer these questions as quickly as possible. Participants in these trials are closely monitored and receive quality care from clinical trial staff for all aspects of their disease.
Expanded access, sometimes called compassionate use, is a potential pathway for a patient with an immediately life-threatening condition or serious disease or condition to gain access to an investigational therapy for treatment outside of a clinical trial when no comparable or satisfactory alternative therapy options are available. This is different from a clinical trial, where more comprehensive safety and efficacy data are monitored and collected.
Given our desire to diligently adhere to a well-defined development program leading to a potential product approval, participation in one of our clinical trials is the only way we are currently offering access to any of our investigational therapies.
If you have questions, you may contact Catalyst Biosciences directly at email@example.com. We anticipate responding to any questions as soon as we can and within 1 week of receipt.
In line with the 21st Century Cures Act, Catalyst Biosciences may revise this policy at any time.