Jun. 4 at 5:51 PM
$CGTX ââŚWhat we're looking at is, as I said, the indication being psychosis, we're working with the psych division of the FDA. We met with them a week and a half ago. We anticipate a 1 to 1 randomization for 100mg of placebo. We're considering a nine month trial. The endpoint will be the NPI two or something like that. And then an open label extension. Of course, to follow these patients over time. So we're in the planning stages. Is this a domestic trial? Is it an international trial? Are there two registrational studies? Is there one single one? All of these very important questions are things we're considering now with our team as we wait for the FDA meeting minutes, which we anticipate having in several weeks. I've talked a lot about the FDA. We've had a very strong partnership with the agencyâŚ.â
Nice
