Among them was the August 2024 letter to Lykos Therapeutics, which declined approval of MDMA-assisted therapy for Posttraumatic Stress Disorder (PTSD).
For the first time, the public can read the FDA’s reasoning behind its rejection.
The Cole Memo received the following statement from MAPS Founder Rick Doblin.
“We commend the FDA, Commissioner Makary, and HHS Secretary Kennedy for making the Complete Response Letter public so the entire field can understand FDA’s reasoning. But let’s be clear: the CRL reveals a devastating truth — the FDA moved the goalposts. In 2017, FDA selected the Phase 3 protocol design after a formal Special Protocol Assessment process, then, after the trials were complete and the application accepted, FDA shifted its standards regarding the approach to the challenge of conducting double-blind studies. In addition, FDA demanded more information after patients and researchers had already poured years of their lives into this process.
The cost of this bureaucratic backpedaling is not abstract. Thirteen million Americans live with PTSD today. Every year of delay means more will die by suicide and more remain trapped in cycles of trauma and despair. They deserve better.
The science is clear, the urgency is undeniable, and the human suffering is immense. Lykos will continue negotiations with the FDA. MAPS will keep driving forward: incubating and accelerating new MDMA-focused research, training therapists around the globe, catalyzing humanitarian projects in high trauma/low resource areas of the world, and building the infrastructure for a future where psychedelic-assisted healing and personal growth is not delayed by shifting politics, but delivered as a matter of compassion and justice.
This is bigger than one agency’s decision. This is about the future of mental health, the integrity of science, and the moral responsibility we all share. We will not stop until safe, legal access to psychedelic-assisted therapies and psychedelics for personal growth are a reality for everyone who needs it.”
FDA’s Complete Response Letter
MAPS Responds to FDA Decision
The Cole Memo is in communication with MAPS leadership, who will be sharing analysis of the FDA’s decision, updates on ongoing research initiatives, and perspectives on the broader implications for the psychedelic field. I will publish these details once they are provided.
My Question to Rick Doblin at a Press Briefing
You can watch my last interaction with Rick Doblin below.
The Cole Memo 
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