Sponsor Overview
Explore verified public information about TME Pharma's expanded access programs, compassionate use policies, and patient eligibility pathways. This report aggregates official statements, independent research, and regulatory data to help patients, providers, and sponsors collaborate efficiently.
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ClinicalTrials.gov data sources power this status.
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Expanded Access Intelligence
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Reagan-Udall Foundation Insights
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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