Thanks for this breakdown. Any thoughts on how this process might unfold for psilocybin as opposed to a drug that's subject to a chemical patent? Funding, timing, etc.
E.g., the company that did the major trials for ketamine actually studied the s-enantiomer of ketamine using a nasal spray, which is quite distinct from the years of data we've accumulated on racemic ketamine with prolonged IV infusion. But this let them get a patentable version of ketamine on the market.
They could get a “method of use” patent that describes treating a co diction with psilocybin.
Even without either of those, the FDA will give them 3 years of market exclusivity (no other drugs will be approved).