Brief: Clovis Oncology Says Had A Type A Meeting With The FDA

Clovis Oncology

06/07/2022 21:42

July 6 (Reuters) - Clovis Oncology Inc  CLVS.O :
    * CLOVIS ONCOLOGY - ON JULY 1, HAD A TYPE A MEETING WITH THE
FDA -
SEC FILING
    * CLOVIS ONCOLOGY - MEETING WITH FDA TO DISCUSS PLANS FOR
SNDA
SUBMISSION FOR FIRST-LINE MAINTENANCE TREATMENT FOR WOMEN WITH
ADVANCED OVARIAN CANCER
    * CLOVIS ONCOLOGY - FDA MAINTAINS THEIR RECOMMENDATION THAT
THE
COMPANY WAIT FOR MORE MATURE OVERALL SURVIVAL DATA TO SUBMIT THE
SNDA
    * CLOVIS - FDA MAINTAINS IF CO CHOOSES TO SUBMIT SNDA PRIOR
TO
RECEIVING MORE MATURE DATA, THEN SNDA MAY NEED TO BE DISCUSSED
AT ADVISORY COMMITTEE MEETING
    * CLOVIS - IN ADDITION, FDA WILL CONSIDER OVERALL SURVIVAL
DATA
FROM OTHER RUCAPARIB CLINICAL TRIALS WHEN IT REVIEWS THE
ATHENA-MONO DATASET
    * CLOVIS - FOLLOWING THE TYPE A MEETING WITH THE FDA,
CURRENTLY
INTENDS TO SUBMIT THE SNDA DURING THE THIRD QUARTER OF 2022
    * CLOVIS - CONTINUES TO PREPARE TYPE II VARIATION FOR
SUBMISSION
TO EMA FOR SAME INDICATION, PLANS TO SUBMIT THAT FILING IN THIRD
QUARTER OF 2022

Source: (https://bit.ly/3yNgseP)
Further company coverage:  CLVS.O 

 ((Reuters.Briefs@thomsonreuters.com;))