Rick Doblin

So it was just a chance. Just turned out that way. Turned out that way. How many people were in this group? 26 people were in the entire study. Okay.

So it was just a chance. Just turned out that way. Turned out that way. How many people were in this group? 26 people were in the entire study. Okay.

Yeah.

Yeah.

Yeah.

Yeah. But it meant to us that this dose of 75 was indeed more therapeutic than we anticipated. So there was no real sweet spot where there was a dose of MDMA that didn't either make people uncomfortable and reduce the effectiveness compared to therapy with no MDMA, or it It tipped over into being very effective.

Yeah. But it meant to us that this dose of 75 was indeed more therapeutic than we anticipated. So there was no real sweet spot where there was a dose of MDMA that didn't either make people uncomfortable and reduce the effectiveness compared to therapy with no MDMA, or it It tipped over into being very effective.

Yeah. But it meant to us that this dose of 75 was indeed more therapeutic than we anticipated. So there was no real sweet spot where there was a dose of MDMA that didn't either make people uncomfortable and reduce the effectiveness compared to therapy with no MDMA, or it It tipped over into being very effective.

So when in November 29th, 2016, when the FDA had what we call the end of phase two meeting, after we got approved to go to phase three, the final studies where you need to prove safety and efficacy. I knew that we shouldn't do that because of this, we shouldn't go directly to phase three. The FDA offers this opportunity that most pharma companies don't take called special protocol assessment.

So when in November 29th, 2016, when the FDA had what we call the end of phase two meeting, after we got approved to go to phase three, the final studies where you need to prove safety and efficacy. I knew that we shouldn't do that because of this, we shouldn't go directly to phase three. The FDA offers this opportunity that most pharma companies don't take called special protocol assessment.

So when in November 29th, 2016, when the FDA had what we call the end of phase two meeting, after we got approved to go to phase three, the final studies where you need to prove safety and efficacy. I knew that we shouldn't do that because of this, we shouldn't go directly to phase three. The FDA offers this opportunity that most pharma companies don't take called special protocol assessment.

And you negotiate every aspect of the phase three design with FDA. And it can take, for us it took eight months. And so pharma companies are thinking there's nothing unusual what I'm doing, my patent life is expiring. But I knew we needed to do that to discuss how to deal with the double blind. And so we presented this information to the FDA.

And you negotiate every aspect of the phase three design with FDA. And it can take, for us it took eight months. And so pharma companies are thinking there's nothing unusual what I'm doing, my patent life is expiring. But I knew we needed to do that to discuss how to deal with the double blind. And so we presented this information to the FDA.

And you negotiate every aspect of the phase three design with FDA. And it can take, for us it took eight months. And so pharma companies are thinking there's nothing unusual what I'm doing, my patent life is expiring. But I knew we needed to do that to discuss how to deal with the double blind. And so we presented this information to the FDA.

We said, we will give you blinding if you want with these lower doses, but it's going to make our job easier to find a difference between the full dose and these lower doses because it's going to compromise the therapy as compared to therapy with no MDMA at all. And so we said to the FDA, you tell us what you want.

We said, we will give you blinding if you want with these lower doses, but it's going to make our job easier to find a difference between the full dose and these lower doses because it's going to compromise the therapy as compared to therapy with no MDMA at all. And so we said to the FDA, you tell us what you want.

We said, we will give you blinding if you want with these lower doses, but it's going to make our job easier to find a difference between the full dose and these lower doses because it's going to compromise the therapy as compared to therapy with no MDMA at all. And so we said to the FDA, you tell us what you want.

And the FDA chose therapy with inactive placebo to make our job harder, which made sense to me. And they said that there's two things that you can do to reduce experimenter bias because the whole purpose of the double blind is to sort of reduce bias that you don't know what's going on and everybody just treats everybody the same. They said the first is this random assignment.

And the FDA chose therapy with inactive placebo to make our job harder, which made sense to me. And they said that there's two things that you can do to reduce experimenter bias because the whole purpose of the double blind is to sort of reduce bias that you don't know what's going on and everybody just treats everybody the same. They said the first is this random assignment.

And the FDA chose therapy with inactive placebo to make our job harder, which made sense to me. And they said that there's two things that you can do to reduce experimenter bias because the whole purpose of the double blind is to sort of reduce bias that you don't know what's going on and everybody just treats everybody the same. They said the first is this random assignment.