Brief: Acer Therapeutics And Relief Therapeutics Announce Update On U.S. FDA Review Of NDA For Acer-001

MindMaze Therapeutics Holding SA

21/06/2022 14:27

June 21 (Reuters) - Acer Therapeutics Inc  ACER.O :
    * ACER THERAPEUTICS AND RELIEF THERAPEUTICS ANNOUNCE UPDATE
ON
U.S. FDA REVIEW OF NEW DRUG APPLICATION (NDA) FOR ACER-001
    * ACER THERAPEUTICS INC - FDA HAS NOT RAISED ANY
APPROVABILITY
CONCERNS RELATED TO EFFICACY, SAFETY OR PHARMACOKINETICS OF
ACER-001
    * ACER THERAPEUTICS INC - FDA HAS NOT RAISED ANY
APPROVABILITY
CONCERNS RELATED TO EFFICACY, SAFETY OR PHARMACOKINETICS OF
ACER-001
    * ACER THERAPEUTICS INC - FDA HAS ISSUED A COMPLETE RESPONSE
LETTER REGARDING NEW DRUG APPLICATION (NDA) FOR ACER-001 (SODIUM
PHENYLBUTYRATE)
    * ACER THERAPEUTICS INC - CRL INDICATES THAT FDA CANNOT
APPROVE
NDA IN ITS CURRENT FORM
    * ACER THERAPEUTICS INC - FDA REQUESTED ADDITIONAL EXISTING
NONCLINICAL INFORMATION TO BE PROVIDED IN RESUBMISSION OF NDA
FOR ACER-001

Source text for Eikon:  ID:nGNX1BcYcY 
Further company coverage:  ACER.O 

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