I’m completely confused. I thought this failed phase 3 trials.
They’ve said they’re continuing development based on FDA draft guidance. I guess the first step for that is showing the phase 2 study used a bioequivalent of what was used in the phase 3 study. (Which is what the news article reports on.)
I think they’re planning to do something like was done with Lumateperone where they combined study results. Minerva has also said they had problems with one (or more) sites, implying that was what caused the lack of statistically significant response.
If they’re willing to keep doing studies, the FDA is willing to review them. I think it is an uphill battle but they could pull it off.
I know someone who takes roluperidone, said it was helpful
Published: 09/30/2021 13:58 GMT
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