http://ir.minervaneurosciences.com/releasedetail.cfm?ReleaseID=1024767
“We recently had a meeting with the U.S. Food and Drug Administration (FDA) to obtain feedback and guidance related to the Phase III clinical development of MIN-101 as a treatment for negative symptoms of schizophrenia,” said Dr. Remy Luthringer, president and chief executive officer of Minerva. “We expect to initiate Phase III development of this compound in the second half of 2017.”
Clinical Development Updates
MIN-101:
An “end-of-Phase II meeting” with the FDA took place recently to review pre-clinical and clinical data generated to date with MIN-101 and to discuss Phase III and Phase IV clinical development of this compound to treat negative symptoms in patients with a diagnosis of schizophrenia, including pivotal trial design.