Restore Mind Medicine
MM-120 Background
MindMed has the rights to two successful, randomized Phase II trials in LSD for GAD,
a Phase I/Ila trial of LSD, and many other supportive studies for psychedelic drugs.
Under Dr. Freeman's leadership, MindMed initiated its pivotal and
fruitful relationship with the University Hospital Basel ("UHB") which
provided this data.
Currently, MindMed has embarked on an ill-conceived, non-pivotal Phase IIb dose
finding study as a prelude to two Phase III trials which are needed for FDA approval.
A Phase IIb dose finding would select the lowest effective dose for the
Phase III study.
We believe this is a flawed strategy as it fails to leverage UHB's randomized
Phase II trials in showing efficacy and safety of LSD in GAD patients.
All CNS drugs approved in the last decade who had a successful Phase II study
did a Phase III dose finding study or a pivotal Phase llb.
Source: Company SEDAR Filings, Company SEC Filings, MindMed Press Releases. See [4]
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