Patients
Expanded Access
65Bio is focused on developing Bio-001 for the treatment of mCRC. Expanded access, also called compassionate use, refers to a pathway in which patients with serious or immediately life-threatening diseases may gain access to an investigational therapy outside the context of participation in clinical trials designed to evaluate safety and efficacy.
General Criteria
65Bio believes that investigational drugs should be studied in patients as part of clinical trials designed to obtain data on safety and efficacy that may be used to support approval of the product which would lead to subsequent wider availability for patients. 65Bio strongly encourages patients to speak with their treating physicians and when possible, to participate in clinical trials. 65Bio is aware that in rare cases patients with serious life-threatening diseases are unable to participate in clinical trials and may have exhausted all available therapies. In these rare cases, 65Bio may consider in the future providing an investigational product outside of a clinical trial. Currently, we do not have an expanded access program that allows patients to have access to our investigational products prior to FDA approval.
Contact Details
Currently 65Bio does not have any investigational product candidates available for expanded access. If you have any questions about our investigational product candidates or expanded access policy, please contact 65Bio through the following email address: info@65bio.com.
Requested Procedure
65Bio is not currently making its investigational products available on an expanded access basis anywhere in the world. In the event that 65Bio decides to consider making one or more of its investigational products available through an expanded access program, requests for expanded access to 65Bio investigational products must come from the patient’s treating physician.
Timing of Acknowledgment
65Bio anticipates that it will acknowledge receipt of any expanded access questions or requests within five to ten business days of receipt.
Clinicaltrials.gov
As stated above, 65Bio is not currently making its investigational product candidates available for expanded access use anywhere in the world. In the event that 65Bio decides to make its investigational product candidates available on an expanded access basis, this policy will be updated with a hyperlink to the expanded access record on clinicaltrials.gov after such record becomes active. As authorized by the 21st Century Cures Act, 65Bio may revise this expanded access policy at any time. Additionally, the posting of this policy by 65Bio shall not serve as a guarantee of access to any specific investigational drug by any individual patient.