Minerva Neurosciences, Inc: roluperidone

(1) You have not established substantial evidence of effectiveness (SEE) for the effects of roluperidone on the negative symptoms of schizophrenia.

Study MINI-101C03 (Study C03) demonstrated statistical significance on the primary efficacy endpoint.

You must provide additional data to demonstrate the safety and efficacy of roluperidone coadministered with antipsychotic medications, to support that observed effect on negative symptoms with roluperidone treatment corresponds to a clinically meaningful change, and to demonstrate the long-term safety of the proposed dose.

These submissions will not be reviewed in the current cycle because of the limited time remaining before the PDUFA date and the inability of these submissions to impact the overall regulatory decision-making related to this application.