Restore Mind Medicine
The Unprecedented Phase llb
Claim: First MindMed claimed that a Phase IIb Is a Required Step for a CNS Drug
FCM analyzed all 62 successful CNS drug candidates in the last decade and found that each either
used either a pivotal Phase Ilb or Phase III study in their regulatory strategy following a successful,
randomized Phase II.
See [11], [12]
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In other words, none of the developers of the 62 novel approved drugs found a need for the
study Phase IIb study MindMed has undertaken. Experienced developers do dose finding in
Phase III rather than Phase Ilb to save time and money.
FCM reviewed each of the 62 novel CNS drugs approved from 2012 to April
2023 and found that 66% did dose finding in Phase III instead of a Phase II.
MindMed claims that investigator-initiated (IIT) studies are for "hypothesis generating." In reality,
the FDA routinely allows IIT studies to be used to support a company's clinical development path.
In some cases, IIT studies were the only studies used for approval. The US government offers
tens of millions of dollars in grant money for Phase III IIT in CNS through NINDS.
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