Clovis Oncology Inc

NASDAQ:CLVS   4:00:00 PM EDT
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Clovis Oncology Inc Says On Nov 14, At Request Of FDA, Co Met With FDA To Discuss The Overall Survival Data From The Co's ARIEL3 Clinical Trial

Published: 11/16/2022 22:42 GMT
Clovis Oncology Inc (CLVS) - Clovis Oncology Inc - on Nov 14, at Request of FDA, Co Met With FDA to Discuss the Overall Survival Data From the Co’s Ariel3 Clinical Trial.
Clovis - FDA Requested Co Voluntarily Revise Label to Limit Indication of Rubraca in This Second-line Maintenance Treatment to Tbrca Patients Only.
Clovis - FDA Further Indicated to Co That If an Agreement Could Not Be Reached on Revised Indication, FDA Would Convene Odac Meeting to Review Matter.
Clovis - Company is Currently Evaluating FDA’s Request.
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