The FDA spells out 4 reasons why it hates Minerva’s NDA ideas — but the biotech is going for it anyway
To put it mildly, regulators at the FDA have a few problems with Minerva’s $NERV failed schizophrenia drug roluperidone.
The biotech spelled it out in a statement Tuesday morning, noting that in their Type C meeting the agency noted:
— The Phase IIb did not use the commercial formulation of the drug.
— The trial was conducted completely outside the US.
— The Phase III failed — at both doses — and “does not appear to be capable of supporting substantial evidence of effectiveness.”
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