Brief: Beyondspring Pharmaceuticals Receives Complete Response Letter From FDA For Plinabulin New Drug Application For Prevention Of Chemotherapy-Induced Neutropenia

Beyondspring

01/12/2021 13:26

Dec 1 (Reuters) - Beyondspring Inc  BYSI.O :
    * BEYONDSPRING PHARMACEUTICALS RECEIVES COMPLETE RESPONSE
LETTER
FROM THE FDA FOR PLINABULIN NEW DRUG APPLICATION FOR PREVENTION
OF CHEMOTHERAPY-INDUCED NEUTROPENIA (CIN)
    * BEYONDSPRING PHARMACEUTICALS RECEIVES COMPLETE RESPONSE
LETTER
FROM THE FDA FOR PLINABULIN NEW DRUG APPLICATION FOR PREVENTION
OF CHEMOTHERAPY-INDUCED NEUTROPENIA (CIN)
    * BEYONDSPRING INC - FDA'S CRL INDICATED THAT RESULTS OF
SINGLE
REGISTRATIONAL TRIAL (106 PHASE 3) WAS NOT SUFFICIENTLY ROBUST
TO DEMONSTRATE BENEFIT
    * BEYONDSPRING -  CRL INDICATED A SECOND WELL CONTROLLED
TRIAL
WOULD BE REQUIRED TO SATISFY SUBSTANTIAL EVIDENCE REQUIREMENT TO
SUPPORT CIN INDICATION
    * BEYONDSPRING INC -  FDA ISSUED CRL TO INDICATE THEY HAVE
COMPLETED REVIEW OF NDA AND HAVE DETERMINED THAT IT CANNOT BE
APPROVED IN ITS PRESENT FORM

Source text for Eikon:  ID:nGNX9V9vfc 
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