Robin Carhart-Harris

And so they were very vulnerable in that regard.

And so some of the data quality issues in terms of all AEs being reported, I can sort of see how that could

happened some of the some of the sites you know they weren't traditional clinical research sites some of the dosings happening in people's you know homes these are clinicians but still it wasn't very much wasn't the traditional model and so i can see how it went that way

I think the FDA made some errors in terms of their misunderstanding of psychedelic medicine and therapy.

Ultimately, they're a regulatory body that approved drugs, drugs as medicines.

And so they want to be able to look at the profile of the drug.

And as this treatment was presented to them,

It was a combination treatment.

Even in the framing of it, I think it was psychedelic-assisted therapy or MDMA-assisted therapy for post-traumatic stress disorder.

So that's leaning emphasis on the therapy.

And the FDA say, well, this isn't our remit.

We're not a body to approve psychotherapy.

So this is confusing to us.

And I think that tripped things up quite considerably.

And I say compass pathways with psilocybin are playing it very differently.

They're much more traditional.

How do you think about the promise of psychedelics?

Is it inextricably bound up with the role of a therapist or some sort of therapeutic context, or do you think the compounds and their utility are totally divorceable from context in that way?

Certainly not.

Yeah, I've