Minerva Neurosciences Inc

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Minerva Neurosciences Announces Outcome Of Type C Meeting With FDA And Next Steps In The Development Of Roluperidone

Published: 12/01/2020 13:14 GMT
Minerva Neurosciences Inc (NERV) - Minerva Neurosciences Announces Outcome of Type C Meeting With FDA and Next Steps in the Development of Roluperidone.
Minerva Neurosciences - FDA Advised Phase 2b Study is Problematic As It Did Not Use Commercial Formulation of Roluperidone, Was Conducted Solely Outside U.S.minerva Neurosciences - FDA Commented That Phase 3 Study Does Not Appear to Be Capable of Supporting Substantial Evidence of Effectiveness.
Minerva Neurosciences - FDA Cautioned That NDA Submission Based on Current Data From Phase 2b & Phase 3 Studies Would Be Highly Unlikely to Be Filed.
Minerva Neurosciences - FDA Acknowledged That Data From Phase 2b and Phase 3 Studies Appear to Show Promising Signals.
Minerva Neurosciences - FDA Encouraged Co to Continue Development of Roluperidone for Treatment of Negative Symptoms in Schizophrenia.
Minerva Neurosciences - Believes FDA's Comments Can Be Addressed Based on Published Regulatory Guidance & Precedents.
Minerva Neurosciences - Intends to Continue Development and NDA Activities Consistent With FDA's Dec 2019 Draft Guidance.
Minerva Neurosciences - Plan to Continue to Move Forward With Clinical Pharmacology, Non-clinical, Cmc Work to Support NDA Submission for Roluperidone.
Minerva Neurosciences - Expect to Request Pre-nda Meeting With FDA to Discuss NDA Submission Plans Based on Clinical Efficacy and Safety Data.