Brief: Isofol Medical AB Will Not Reach 300 PFS Events In Agent Study With Current Censoring Rules Based On FDA Decision

Isofol Medical AB (publ)

03/12/2021 19:20

Dec 3 (Reuters) - Isofol Medical AB (publ)  ISOFOL.ST :
    * WILL NOT REACH 300 PFS EVENTS IN AGENT STUDY WITH CURRENT
CENSORING RULES BASED ON FDA DECISION
    * ISOFOL MEDICAL AB - U.S. FDA DENIED A REQUEST FROM CO TO
ADJUST
ANALYSIS OF PIVOTAL AGENT STUDY'S SECONDARY ENDPOINT OF
PROGRESSION-FREE SURVIVAL (PFS
    * DECISION WILL NOT AFFECT STUDY'S PRIMARY ENDPOINT,
OBJECTIVE
RESPONSE RATE, PREVIOUSLY AGREED UPON WITH FDA
    * SECONDARY ENDPOINT MAY HAVE TO BE SOMEWHAT MODIFIED
    * AGENT STUDY'S PRIMARY ENDPOINT OF OVERALL RESPONSE RATE
(ORR) IS
NOT AFFECTED, STUDY IS CONTINUING ACCORDING TO PLAN
    * DECISION MAY CAUSE A DELAY OF TOP-LINE RESULTS OF
ARFOLITIXORIN
IN ADVANCED, METASTATIC COLORECTAL CANCER

Source text for Eikon:  ID:nWkr6SRrhT 
Further company coverage:  ISOFOL.ST 

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