TWi Biotechnology, Inc. (“TWiB”) is a clinical-stage biopharmaceutical company dedicated to developing innovative treatments for patients suffering from diseases with unmet medical needs.

In accordance with Section 561A of the U.S. FD&C Act, an expanded access request may only be considered for patients with serious or immediately life-threatening conditions who lack comparable alternative therapies, provided that the potential benefits justify the risks and the investigational drug supply will not interfere with ongoing clinical trials.

Our Policy on Expanded Access

TWiB has established the following policy regarding expanded access (compassionate use):

• Physician-Initiated Requests: Expanded access requests must be initiated and submitted exclusively by a qualified, licensed treating physician on behalf of their patient(s). TWiB does not accept or review direct requests from patients or families.
• Physician-Initiated Requests: Expanded access requests must be initiated and submitted exclusively by a qualified, licensed treating physician on behalf of their patient(s). TWiB does not accept or review direct requests from patients or families.
•  Case-by-Case Evaluation: TWiB will evaluate each physician-initiated request on a case-by-case basis. Approval is strictly contingent upon investigational drug supply availability, production capacity, and the establishment of appropriate clinical, logistical, and safety supporting mechanisms to ensure patient safety.
  

Contact Information

Licensed treating physicians seeking to submit a formal expanded access inquiry or proposal may contact our medical affairs team:

• Contact Email: EAP_info@twibiotech.com 
• Anticipated Response Frame: TWiB will acknowledge receipt and respond to formal inquiries as promptly as practicable following the receipt of all required clinical and administrative information.
  
  

Disclaimer: This statement is posted to comply with U.S. statutory requirements. Publication of this policy or submission of an inquiry does not guarantee access to any investigational drug. TWiB reserves the right to modify or terminate this policy at its sole discretion.