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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