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Roluperidone NDA receives CRL from FDA 🙁
⚠️ FDA cited clinical deficiencies:
▪️ Insufficient substantial evidence of effectiveness
▪️ lacks data on concomitant antipsychotic admin.
▪️ lacks data to establish change in negative symptoms of schizophrenia
▪️ inadequate number of subjects exposed at proposed dose
▪️ Insufficient substantial evidence of effectiveness
▪️ lacks data on concomitant antipsychotic admin.
▪️ lacks data to establish change in negative symptoms of schizophrenia
▪️ inadequate number of subjects exposed at proposed dose
ℹ️Add'l info on Roluperidone…
⇒ for negative symptoms of schizophrenia
⇒ NDA
⇒ PDUFA: 02/26/24
⇒ for negative symptoms of schizophrenia
⇒ NDA
⇒ PDUFA: 02/26/24
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OptionalOptions : Do you just post all FDA info?