Brief: Minerva Neurosciences Receives Refusal To File Letter From FDA For Its New Drug Application For Roluperidone

Minerva Neurosciences

17/10/2022 13:58

Oct 17 (Reuters) - Minerva Neurosciences Inc  NERV.O :
    * MINERVA NEUROSCIENCES RECEIVES REFUSAL TO FILE LETTER FROM
FDA
FOR ITS NEW DRUG APPLICATION FOR ROLUPERIDONE FOR THE TREATMENT
OF NEGATIVE SYMPTOMS IN SCHIZOPHRENIA
    * MINERVA NEUROSCIENCES INC - FDA HAS INDICATED THAT COMPANY
CAN
REQUEST A TYPE A MEETING TO DISCUSS CONTENT OF REFUSAL TO FILE
LETTER
    * MINERVA NEUROSCIENCES INC - INTENDS TO REQUEST A TYPE A
MEETING
AND LOOKS FORWARD TO CONTINUED DISCUSSIONS WITH FDA

Source text for Eikon:  ID:nGNX4V1TS8 
Further company coverage:  NERV.O 
 ((Reuters.Briefs@thomsonreuters.com;))