Minerva Neurosciences Inc

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Minerva Neurosciences Says FDA Cautioned That NDA Submission Based On Current Data From Phase 2b And Phase 3 Studies Would Be Highly Unlikely To Be Filed

Published: 12/01/2020 12:32 GMT
Minerva Neurosciences Inc (NERV) - Minerva Neurosciences - on Dec 1, Got Official Meeting Minutes From Co's Nov 10, Type C Meeting With U.S. FDA.
Minerva Neurosciences - Objective of Meeting Was to Obtain FDA Input Regarding Roluperidone Data Package and Its Readiness to Support NDA Submission.
Minerva Neurosciences - FDA Advised That Phase 2b Study is Problematic Because It Did Not Use Commercial Formulation of Roluperidone.
Minerva Neurosciences - FDA Cautioned That NDA Submission Based on Current Data From Phase 2b and Phase 3 Studies Would Be Highly Unlikely to Be Filed.
Minerva Neurosciences - Intends to Continue Development & NDA Activities Consistent With FDA’s Dec 2019 Draft Guidance.