Minerva sciences press release: roluperidone

Looks like they are still pushing to have it approved!

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“Although the trial did not meet its primary endpoint due, we believe, to an unexpected high placebo response, we are encouraged by the study results. The consistency of reduction in overall negative symptoms and in the most important subtypes of these symptoms is similar to that observed in the previous Phase 2b study.”

I wonder if the FDA will make them do another study.

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They didn’t make lumeteperone do another study. They just approved it, didn’t they?

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Yes, but it seems Intracellular was able to show that the problem was just at a few sites and if you took those sites out it met the criteria; additionally, if you averaged the several studies they did together, it met the criteria even including the problematic sites. If Minerva can do that, they’re probably good.

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