Expanded Access Intelligence

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Reagan-Udall Foundation Insights

Additional Information

Single-Patient EA Policies/Criteria At this time, TME Pharma is not offering Expanded Access for NOX-A12 (olaptesed pegol). Access to NOX-A12-based therapies is currently available only through participation in our clinical trials which allows us to allocate available supply to study the drug’s effectiveness and safety in a controlled and evaluable setting. For more information on our clinical trials that may be recruiting new patients, please consult www.clinicaltrials.gov . We understand the interest of patients in accessing NOX-A12 outside of clinical trials and prior to regulatory approval but we believe investigational products should be studied within the context of a clinical trial and encourage patients to enroll in a clinical trial wherever possible. We recognize the need for Expanded Access programs, and we will re-evaluate the status of our policy based on data from ongoing and future clinical trials.

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