Rick Doblin

And so the people in the advisory committee are often more academics, and they're more focused on this double-blind issue, but they're not practical in a sense. So that the FDA realizes that the double-blind fails in practice a lot. It's a theory of how you want to do things. It's something to strive for, but it doesn't work a lot of the times.

Even with SSRIs, you think that Prozac or various drugs that you take that are not psychedelic, that those are easy to double-blind. But they're not because when people have sexual side effects, they have other side effects, and they report to their therapist what's going on, then they can tell from the side effect profile. So the double blind fails in practice a lot.

Even with SSRIs, you think that Prozac or various drugs that you take that are not psychedelic, that those are easy to double-blind. But they're not because when people have sexual side effects, they have other side effects, and they report to their therapist what's going on, then they can tell from the side effect profile. So the double blind fails in practice a lot.

Even with SSRIs, you think that Prozac or various drugs that you take that are not psychedelic, that those are easy to double-blind. But they're not because when people have sexual side effects, they have other side effects, and they report to their therapist what's going on, then they can tell from the side effect profile. So the double blind fails in practice a lot.

But the FDA is saying we can't just only approve drugs where the double blind is perfect. We have to weigh these different things. So that was one of the big issues that the FDA Advisory Committee objected to, was this functional unblinding. So when you asked about the timeframe, there was other issues, but where we're at right now,

But the FDA is saying we can't just only approve drugs where the double blind is perfect. We have to weigh these different things. So that was one of the big issues that the FDA Advisory Committee objected to, was this functional unblinding. So when you asked about the timeframe, there was other issues, but where we're at right now,

But the FDA is saying we can't just only approve drugs where the double blind is perfect. We have to weigh these different things. So that was one of the big issues that the FDA Advisory Committee objected to, was this functional unblinding. So when you asked about the timeframe, there was other issues, but where we're at right now,

is that there's going to be negotiations between Lycos and the FDA. With the new FDA, with the new people at HHS, and there's two, the proverbial fork in the road, there's either the FDA will say, Believe your data enough that you're not going to need to do another phase three study.

is that there's going to be negotiations between Lycos and the FDA. With the new FDA, with the new people at HHS, and there's two, the proverbial fork in the road, there's either the FDA will say, Believe your data enough that you're not going to need to do another phase three study.

is that there's going to be negotiations between Lycos and the FDA. With the new FDA, with the new people at HHS, and there's two, the proverbial fork in the road, there's either the FDA will say, Believe your data enough that you're not going to need to do another phase three study.

They might require what's called a phase four study, which is after approval, you gather information about safety, about durability, different things. And if that's the case, it's possible that within six months, the FDA could say yes to approving MDMA-assisted therapy for PTSD. If the FDA says we want another phase three study, that could delay approval for another three and a half years or so.

They might require what's called a phase four study, which is after approval, you gather information about safety, about durability, different things. And if that's the case, it's possible that within six months, the FDA could say yes to approving MDMA-assisted therapy for PTSD. If the FDA says we want another phase three study, that could delay approval for another three and a half years or so.

They might require what's called a phase four study, which is after approval, you gather information about safety, about durability, different things. And if that's the case, it's possible that within six months, the FDA could say yes to approving MDMA-assisted therapy for PTSD. If the FDA says we want another phase three study, that could delay approval for another three and a half years or so.

And that's just on an individual basis. So talk about frustration. I mean, we had incredible outcomes. So the two phase three studies that were done, The first one was severe PTSD.

And that's just on an individual basis. So talk about frustration. I mean, we had incredible outcomes. So the two phase three studies that were done, The first one was severe PTSD.

And that's just on an individual basis. So talk about frustration. I mean, we had incredible outcomes. So the two phase three studies that were done, The first one was severe PTSD.

And what we showed is that two-thirds of the people that had severe PTSD no longer had PTSD after the treatment, which was 42 hours of therapy, three MDMA sessions one month apart, 12 90-minute non-drug psychotherapy sessions. Two-thirds no longer had PTSD that got therapy plus MDMA. And those people that got therapy Without MDMA, with the inactive placebo, roughly one-third no longer had PTSD.

And what we showed is that two-thirds of the people that had severe PTSD no longer had PTSD after the treatment, which was 42 hours of therapy, three MDMA sessions one month apart, 12 90-minute non-drug psychotherapy sessions. Two-thirds no longer had PTSD that got therapy plus MDMA. And those people that got therapy Without MDMA, with the inactive placebo, roughly one-third no longer had PTSD.

And what we showed is that two-thirds of the people that had severe PTSD no longer had PTSD after the treatment, which was 42 hours of therapy, three MDMA sessions one month apart, 12 90-minute non-drug psychotherapy sessions. Two-thirds no longer had PTSD that got therapy plus MDMA. And those people that got therapy Without MDMA, with the inactive placebo, roughly one-third no longer had PTSD.

And then another roughly 20% had what's called clinically significant reductions of PTSD symptoms, means that their life has changed, their symptoms are not as burdensome, but they still have PTSD. So they're called responders. So we had 88% responders, only 12% non-responders. Wow. It's the best treatment.