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meirluc

08/08/19 8:31 AM

#238915 RE: Umibe5690 #238898

Umibe I disagree. First of all I would like to have more details as to roughly what you predict the top line results will contain.

Why in your opinion in this trial is the mPFS and mOS for placebo/control and treatment so important? Even more important can you envision the results concerning the 5 year OS and PFS for placebo/control and treatment?.

In my opinion in this trial, long tail survival and progression results for patients with methylated and unmethylated GBM will receive major emphasis and will be much more important than mPFS and mOS.

This is not a chemotherapeutic trial. It is an immunotheraprutic trial and the elaborate new SAP is designed to deal with this new reality.

The FDA is not the only player here. NICE and the two other RAs will make their own decision. Some posts here seem to subconsciously perhaps convey the impression that if the FDA withholds approval, automatically other RAs will follow suit. I doubt very much that this is true. I believe the trial will succeed and will be approved by all 4 RAs.