Run trials with an astounding number of easily avoidable flaws, win stupid prizes. It would be a shame for this to turn into an overall setback for psychedelic therapy.
Sure, the FDA could go against the recommendation, but that’s a political nonstarter given the problems included sexual assault. We need studies that are unassailable on the data collection such that the psychoactive (qualitative) effects are just an outlier in the list of quantitative results.
I was rooting for this therapy, but not at the expense of exposing vulnerable people to all the hokum that Lykos was apparently trying to spike it with. FDA made the right call for now.