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MindMed is a clinical-stage biopharmaceutical company developing novel product candidates to treat brain health disorders. We believe that the most efficient way to bring safe and effective medicines to all appropriate patients is by conducting rigorous clinical trials. Therefore, MindMed is currently conducting clinical trials to evaluate the safety and efficacy of our investigational medications to obtain the necessary approvals as required by the United States Food and Drug Administration (FDA) and other regulatory agencies.
Expanded access programs, also known as compassionate use, are potential pathways for patients to receive investigational medications that are not approved by the FDA but that may be beneficial for life-threatening or serious conditions, or conditions for which no satisfactory authorized therapies are available. Under strict guidelines, patients unable to participate in a clinical trial may be provided with investigational medication prior to regulatory approval.
MindMed recognizes the value that expanded access programs provide; however, at this time, we believe that the most appropriate way to receive our investigational medication is through one of our clinical trials. The structure and oversight provided in the context of our clinical trials help to ensure that important safety and efficacy monitoring practices are in place, protecting patients and ensuring that the development of our investigational medications proceed as quickly as possible, allowing for the greatest distribution of our products to patients in need of treatment.
Patients and physicians are encouraged to visit clinicaltrials.gov listings for information about our ongoing trials. If you have additional questions regarding our policy, please have your physician contact [email protected]. We anticipate acknowledging receipt of requests sent to this email within five (5) business days.
MindMed recognizes that patients in need may not be able to participate in clinical trials and is evaluating the appropriate timing and conditions under which Expanded Access may be made available.
MindMed’s Expanded Access Policy may be revised at any time, in line with the 21st Century Cures Act. Hyperlinks to clinicaltrials.gov listings will be updated after the trial record becomes available. This policy is current as of 15 March 2024.
Click here for links to our clinical trials.
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