Expanded Access Policy
ReNetX Bio is developing AXER-204 as treatment for chronic spinal cord injury. We are committed to advancing this investigational therapy as a safe and effective medicine for patients as quickly as possible.
At this time, ReNetX Bio is unable to provide unapproved medicines via expanded access (also referred to as compassionate use) and believes that participating in its clinical trial is the best way to access this medicine that is not yet approved by U.S. Food and Drug Administration. We have considered many factors, including our ability to maintain supply for the planned clinical trial, enroll and complete the upcoming clinical trial, and make reasonable assessments of potential risk versus benefit for patients outside the clinical trial setting. In the event that ReNetX Bio decides to consider expanded access use for AXER-204 in the future, we will evaluate and respond to each expanded access request on a case-by-case basis using criteria that ensures such requests are considered in a fair and consistent manner.
If you or a family member are/is interested in gaining access to our investigational therapy, we encourage you to consult with your physician regarding the possibility of participating in our clinical trial.
For additional information about this posted policy or if you are a treating physician requesting expanded access, please contact us via email at info@ renetx.com. We anticipate acknowledging receipt of such inquiries sent to this email within 2 business days.
The posting of this policy by ReNetX Bio shall not serve as a guarantee of access to any specific investigational drug by any individual patient. In accordance with the 21st Century Cures Act, ReNetX Bio may revise this expanded access policy at any time. The policy will be updated with a hyperlink or other reference to the expanded access record on clinicaltrials.gov after such record becomes active.
At this time, ReNetX Bio is unable to provide unapproved medicines via expanded access (also referred to as compassionate use) and believes that participating in its clinical trial is the best way to access this medicine that is not yet approved by U.S. Food and Drug Administration. We have considered many factors, including our ability to maintain supply for the planned clinical trial, enroll and complete the upcoming clinical trial, and make reasonable assessments of potential risk versus benefit for patients outside the clinical trial setting. In the event that ReNetX Bio decides to consider expanded access use for AXER-204 in the future, we will evaluate and respond to each expanded access request on a case-by-case basis using criteria that ensures such requests are considered in a fair and consistent manner.
If you or a family member are/is interested in gaining access to our investigational therapy, we encourage you to consult with your physician regarding the possibility of participating in our clinical trial.
For additional information about this posted policy or if you are a treating physician requesting expanded access, please contact us via email at info@ renetx.com. We anticipate acknowledging receipt of such inquiries sent to this email within 2 business days.
The posting of this policy by ReNetX Bio shall not serve as a guarantee of access to any specific investigational drug by any individual patient. In accordance with the 21st Century Cures Act, ReNetX Bio may revise this expanded access policy at any time. The policy will be updated with a hyperlink or other reference to the expanded access record on clinicaltrials.gov after such record becomes active.