Brief: Tricida Provides Regulatory Update On Veverimer

Tricida

15/07/2020 23:22

July 15 (Reuters) - Tricida Inc  TCDA.O :
    * TRICIDA PROVIDES REGULATORY UPDATE ON VEVERIMER
    * TRICIDA - AS PART OF ONGOING REVIEW OF NDA, FDA IDENTIFIED
DEFICIENCIES THAT PRECLUDE DISCUSSION OF LABELING &
POSTMARKETING REQUIREMENTS/COMMITMENTS
    * TRICIDA INC - FDA STATED THAT NOTIFICATION DOES NOT
REFLECT A
FINAL DECISION ON INFORMATION UNDER REVIEW
    * TRICIDA INC - PLANS TO WORK WITH FDA TO IDENTIFY AND SEEK
TO
RESOLVE DEFICIENCIES
    * TRICIDA INC - HAS NO CURRENT PLANS TO MODIFY OR SUSPEND
ONGOING
CONFIRMATORY POSTMARKETING TRIAL, VALOR-CKD
    * TRICIDA INC - IS UNABLE TO EVALUATE WHETHER IT WILL BE
ABLE TO
ADDRESS FDA'S CONCERNS

Source text for Eikon:  ID:nBw4Rgvnra 
Further company coverage:  TCDA.O 

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