Cogent Biosciences’ Policy on Access to Investigational Therapies
Cogent Biosciences Inc. (Cogent) is a clinical-stage biotechnology company committed to developing novel precision therapies to treat genetically defined diseases. We are a Company of people who are passionate and dedicated to turning the promises of our therapies into reality in order to transform the lives of patients. To accomplish this, we work with researchers, clinicians, patients and caregivers impacted by these diseases throughout the clinical development process.
Expanded access refers to the use of an investigational therapy outside a clinical trial when the primary purpose is to diagnose, monitor, or treat a serious condition in a patient. This is different from a clinical trial, where more comprehensive information on the safety and effectiveness of an investigational therapy is collected. We understand the need for expanded access programs for patients.
At this time, we are not considering requests for access to our investigational therapies outside of clinical trials. We believe that the most appropriate way to deliver on our commitment to patients is through completion of our clinical trials and subsequent successful registration of our medicine(s) as this will provide us with the greatest opportunity to potentially provide long-term access to as many patients as possible.
For more information regarding our current clinical trials, please visit www.clinicaltrials.gov.
Consistent with the 21st Century Cures Act, Cogent may revise this policy at any time.