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  "notes": "Two-column layout: left side has line illustration of clinical documents (vial, briefcase, paper); right side stacks claim label, FCM analysis, highlighted finding callout, and IIT study commentary. Source citation '[11], [12]' bottom-left.",
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      "text": "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.",
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      "text": "Claim: First MindMed claimed that a Phase IIb Is a Required Step for a CNS Drug",
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      "text": "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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      "text": "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 IIb to save time and money.",
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      "text": "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.",
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      "text": "FCM analyzed all 62 successful CNS drug candidates in the last decade and found that each either used either a pivotal Phase IIb or Phase III study in their regulatory strategy following a successful, randomized Phase II.",
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      "text": "The Unprecedented Phase IIb",
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