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|Item 8.01|| |
On September 2, 2020, the U.S. Food and Drug Administration (FDA) granted Minerva Neurosciences, Inc. (the “Company”) a Type C meeting, and scheduled it to take place via teleconference on November 10, 2020.
This meeting will provide an opportunity for the Company to review clinical data generated to date with roluperidone, including the recently completed Phase 3 trial of roluperidone for treatment of negative symptoms in schizophrenia, and to solicit comments and recommendations from the FDA regarding these data and the readiness of the roluperidone data package to support a new drug application submission.
It is possible that the FDA could cancel or reschedule this meeting, and the Company does not expect to receive the official minutes of the meeting until mid or late December, 2020.
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
|MINERVA NEUROSCIENCES, INC.|
|Title:||Executive Vice President, Chief Financial Officer and Chief Business Officer|
Date: September 8, 2020