Fore Biotherapeutics

“Fore Biotherapeutics is an oncology-focused biotechnology company dedicated to developing innovative treatments that provide a better outcome for cancer patients. Our goal is to efficiently bring safe and effective medicines to all appropriate patients by conducting rigorous clinical trials and obtaining marketing approval by regulatory authorities. Drugs which are being studied in clinical trials and not yet been approved as safe and effective by regulatory agencies such as the FDA are called investigational drugs. Prior to such approval, participation in a clinical trial is the best way for patients to gain access to our investigational drugs. Information on clinical trials can be found here. However, we understand that some patients may not be able to participate in a clinical trial and may wish to seek access to investigational drugs before they are approved. Expanded access, also called “compassionate use” or “named patient access” at Fore Biotherapeutics is the use of an investigational drug outside the clinical trial setting. It is intended to provide a treatment option for patients with a serious or life-threatening condition who are not eligible for or able to participate in a clinical trial and where there may be no other treatment options available. When requested by a treating physician for a patient, Fore Biotherapeutics may provide access to the investigational product for individual patient use outside of the clinical trial setting when appropriate, and under requesting physician supervision. Due to variations in regulatory requirements in different territories concerning the provision of investigational products for expanded access, regional policies and local regulations will be considered prior to granting each request.”