Restore Mind Medicine
MM-120: Greenleaf Report
MindMed hired a paid consultant Greenleaf to justify its current FDA strategy.
Greenleaf's report is supported based on the facts MindMed provided to them.
Greenleaf did not talk to FCM or ask for supporting materials which resulted in a seriously
deficient report predicated on strawman arguments and misrepresentation of our plans.
Greenleaf did not dispute FCM's analysis of each CNS drug approved in the last decade which
found that none of those drugs have followed the long, expensive, and tortuous path to drug
approval as the plan initiated by MindMed for LSD.
Greenleaf does not deny the ability of MindMed to execute FCM's plan with the FDA nor does
Greenleaf say it believes MindMed's current path is the best way forward.
Greenleaf states that Liechti's published data cannot be used; but did not dispute FCM's plan to
use Dr. Liechti's published and unpublished original data owned by MindMed in a clinical study
report to show LSD's effectiveness in Phase II to meet FDA's requirement of "preliminary evidence."
Greenleaf quotes FDA regulations, which supports FCM's approach stating that “[Phase 3 studies]
are performed after preliminary evidence suggesting effectiveness of the drug has been obtained in
Phase 2." Dr. Liechti's randomized Phase II studies satisfy this requirement as FCM has stated.
Source: Company SEC Filings, Greenleaf Report. See [3].
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