Brief: Santhera: Finalization Of NDA Submission For Vamorolone Postponed

Santhera Pharmaceuticals Holding AG

29/06/2022 06:08

June 29 (Reuters) - SANTHERA PHARMACEUTICALS HOLDING AG
 SANN.S :
    * SANTHERA UPDATES ON ONGOING NDA SUBMISSION FOR VAMOROLONE
    * ROLLING SUBMISSION HAS BEEN PROCEEDING ACCORDING TO PLAN
WITH
CLINICAL MODULE SUBMITTED ON JUNE 28, 2022
    * CLINICAL MODULE OF ITS ROLLING NEW DRUG APPLICATION (NDA)
FOR
VAMOROLONE IN DUCHENNE MUSCULAR DYSTROPHY (DMD) HAS BEEN
SUBMITTED TO U.S. FDA
    * FINALIZATION OF NDA SUBMISSION TO START FDA OFFICIAL
REVIEW IS
POSTPONED BY 4-6 MONTHS TO Q4-2022
    * FINALIZATION OF NDA SUBMISSION POSTPONED AFTER THIRD-PARTY
CONTRACT MANUFACTURING ORGANIZATION COMMUNICATED DELAY IN
ESTABLISHING FDA-INSPECTION READINESS

Source text for Eikon:  ID:nGNE40gCDb 
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