Restore Mind Medicine
The Irrefutable Need For Change
Botched Regulatory Strategy of MM-110
Resulting in Program's Termination
Regulatory Failure:
MindMed dosed patients in a Phase I study 35x higher
than the FDA would allow without performing additional
preclinical safety studies. When MindMed was preparing
to initiate a Phase II study, the FDA reminded them of the
requirement, and then MindMed shuttered the program
because it would take "months to years" to complete.
Clinical Design Flaws:
MindMed stopped at a 7-day dosing regimen for
opioid withdrawal symptoms, a significantly smaller
market than treating opioid addiction which would
require a 30-day dosing regimen.
Source: Company SEC Filings, MindMed Press Releases, Clinicaltrails.gov. See [3], [4]
Flawed Strategy for Core Drug MM-120
Regulatory Failure:
MindMed embarked on a Phase Ilb dose finding study for
MM-120 which was unnecessary as evidenced by the
fact that every other approved CNS drug with successful
phase II studies did a phase III dose finding study or a
pivotal Phase Ilb; a cheaper and quicker path to approval.
Clinical Design Flaws:
The Phase Ilb only tests a one dose regimen while three
successful randomized Phase II studies used two doses.
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