Clearmind Medicine Delivers Briefing to FDA Following Invitation to Historic Psychedelic Hearing in Washington, D.C.

Mary-Elizabeth Gifford, Chief of Global Impact at Clearmind Medicine ( CMND ), spoke on patient access and shared insights from Clearmind’s clinical trial at Yale and Johns Hopkins

Vancouver, Canada, Sept. 17, 2026 (GLOBE NEWSWIRE) — Clearmind Medicine Inc. ( CMND ) (the “Company” or “Clearmind”), a clinical-stage biopharmaceutical company advancing non-hallucinogenic psychedelic-derived neuroplastogen for scalable treatment of neuropsychiatric, metabolic, and addiction disorders including Alcohol Use Disorder (“AUD”), today announced that, following an invitation from the U.S. Food and Drug Administration (“FDA”), it testified at the FDA’s history-making psychedelic hearing in the nation’s capital on September 14, 2026. Clearmind’s Chief of Global Impact, Mary-Elizabeth Gifford, briefed a federal panel convened by the FDA to evaluate “Considerations for Potential Future Therapeutic Use of Psychedelic Drugs.”

The history-making hearing marked a dedicated federal forum convened by the FDA to gather public input on the potential future therapeutic use of psychedelic drugs, bringing together senior FDA officials and federal partners from Substance Abuse and Mental Health Services Administration (SAMHSA), the National Institutes of Health and the Veterans Health Administration.

Invited to address the question of “Patient Access” Gifford said: “At Clearmind Medicine, our clinical trial at Yale and Johns Hopkins have generated findings suggesting that a next-generation category of psychedelics, neuroplastogenic compounds, which retain the therapeutic benefits of neuroplasticity enhancement while eliminating the hallucinogenic effects of legacy psychedelics, may help mitigate the need for expensive supervised dosing. Our findings have led us to believe that this may represent a scalable treatment model that is a replicable and shareable opportunity for the future of American health.”

In addition to soliciting expertise on patient access, the FDA’s hearing also invited testimony on provider training and credentialing, patient safety, and best practices for data collection and standardization.

Tiffany R. Farchione, M.D., Director, Division of Psychiatry, Center for Drug Evaluation and Research (CDER) Office of New Drugs, sat on the day’s Federal Listening Panel, as did senior leadership from the Substance Abuse and Mental Health Services Administration (SAMHSA), the National Institute on Drug Abuse (NIDA), the Advanced Research Projects Agency for Health (ARPA-H) and the Veterans Health Administration. Approximately 1,800 participants attended the hearing in person and virtually.

At the hearing, Gifford told the FDA panel that next-generation psychedelic neuroplastogens that do not need expensive supervised dosing may reduce health disparities and achieve patient access for those with intractable substance use disorders and “myriad other diagnoses that could be treated safely under medical care.”

She concluded: “This secures responsible patient access, not through new expensive frameworks that are yet to be built, but through America’s already existing primary care and VA resources.”

MEAI, Clearmind’s proprietary drug candidate for the treatment of AUD, a condition that affects one in ten Americans, and is considered a leading cause of preventable deaths for working age adults, is currently being evaluated in FDA-approved clinical trial at Yale University Medical School and Johns Hopkins University. MEAI is also among a limited number of non-hallucinogenic, psychedelic-derived neuroplastogen candidates to have advanced to a Phase 2a clinical trial.

“We are grateful to the FDA and federal health officials for leading this important national conversation and for its visionary encouragement of responsible biopharma innovation in addiction treatment, including the treatment of AUD,” said Adi Zuloff-Shani, Ph.D., Chief Executive Officer of Clearmind Medicine ( CMND ). Zuloff-Shani, Ph.D. added, “We appreciate the opportunity to contribute to this emerging technological field, with MEAI representing our commitment to developing innovative treatments that could ultimately be both effective and more accessible to patients. Mary-Elizabeth Gifford speaks for all of us at Clearmind, articulating our collective mission to bridge rigorous evidence-based research with federal policy that could potentially help us to accelerate improved care for patients across the US and globally.”

Gifford, Clearmind’s Chief of Global Impact, anchors the biopharma’s presence in New York City and Washington, D.C., and has been described by Spirituality & Health magazine as “the most quietly influential woman working in psychedelics today.” Her pro-bono contributions to the field of psychedelic medicine include chairing the steering committee for the Psychedelic Medicine Coalition Annual Federal Psychedelic Summit at the National Press Club and heading the non-profit Global Wellness Institute’s Psychedelics & Healing Initiative.