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Compassionate Use and Pre-Approval Access

Our primary focus is on enrolling patients in clinical trials to obtain the data required for review and approval by regulatory authorities around the world to secure timely and broad availability and access of our products. For information on TB Alliance’s current clinical trials, go to https://www.tballiance.org/portfolio/trials

TB Alliance does not currently have a compassionate use/pre-approval access program. However, TB Alliance recognizes there may be circumstances under which patients with life-threatening or seriously debilitating tuberculosis may seek access to our late-stage investigational medicines and, therefore, TB Alliance is in discussions with potential partners to establish and fund a compassionate use/ pre-approval access program for pretomanid, our proprietary compound in late-stage clinical development. TB Alliance continues to make good faith efforts to comply with the new expanded use access requirements. Once a partnership is established and a compassionate use program operationalized, TB Alliance anticipates that it will take approximately twenty-four (24) to forty-eight (48) hours to process and acknowledge receipt of such requests. TB Alliance will provide a publicly available hyperlink to the clinical trial record containing information about expanded access and use for pretomanid, including the criteria to be used to evaluate patient requests, soon after one is developed and becomes available. If you are interested in learning more about our efforts to establish such a program, please email cu-inquiries@tballiance.org