FDA denies Minerva's pre-NDA meeting request for roluperidone, recommends Type C meeting

Minerva Neurosciences, Inc.

FDA denied pre-NDA meeting for roluperidone (negative symptoms of schizophrenia); recommends Type C guidance meeting instead.
Minerva plans to request the Type C meeting; still targeting NDA submission in first half of 2022.
No FDA-approved drugs exist in the U.S. for negative symptoms of schizophrenia.

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