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Traditional drug approvals deal with molecules. The therapy, if any, is incidental. Psilocybin doesn't fit that model cleanly because the psychological experience appears to be part of what makes the treatment work though the field hasn't fully resolved whether that's because the journey itself is therapeutic, or because the underlying neurobiological and synaptic effects operate independently of what the patient consciously experiences. That distinction matters enormously for how you design your development program.
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