Expanded Access Policy
SAB Biotherapeutics, Inc. (“SAB”) is a clinical-stage biopharmaceutical company uniquely focused on the development of proprietary immunotherapeutic multi-epitope binding human antibodies to treat and prevent infectious diseases, immune and autoimmune disorders, and oncology.
Expanded Access Program (EAP), sometimes called compassionate use, refers to the use of an investigational new drug outside of a clinical trial for patients with serious or life-threatening conditions who have exhausted their treatment options and are not eligible for, or able to participate in, a clinical trial.
SAB believes that participation in one of our clinical trials is the most appropriate way to access our investigational drugs, consistent with U.S. Food and Drug Administration (FDA) recommendation. A list of SAB open clinical trials can be found here: https://clinicaltrials.gov/
However, SAB understands it may not always be possible to participate in or qualify for a clinical trial so SAB will review and evaluate individual requests for EAP. All requests must be initiated by the treating physician. Physicians can submit requests for expanded access to email@example.com. All requests will be responded to within 5 days.
A number of factors consistent with the FDA and other regulatory agencies’ guidelines are taken into account by SAB when considering requests for expanded access. These factors include:
- The patient’s condition must be serious or life-threatening with no other satisfactory treatment options available.
- Potential benefit to the patient justifies the potential risks of the treatment.
- There is an active Investigational New Drug application held by SAB for a desired drug.
- There is adequate supply of the investigational drug.
- Use of the investigational drug will not compromise or delay the conduct of clinical trials or associated regulatory review/approval of the investigational drug for broader patient access.
- The initiating physician is qualified and agrees to assume all responsibilities and obligations to comply with the regulations.
Posting of this policy does not guarantee access to investigational drugs and the policy is subject to change based on each investigational product under development.