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Re: staccani post# 1322

Monday, 09/25/2017 1:12:17 PM

Monday, September 25, 2017 1:12:17 PM

Post# of 2099
My understanding all along is that the DSMC safety review includes efficacy (factoring it in but not reporting it out). This is also mentioned in numerous documents. Dror's comments seem to support what I've said.

Dror Harats

Basically, we are looking safety and that’s their charter. But as we all know, they look at survival as part of or the death event as part of safety of course. And because our primary endpoint is death, or the event are actually survival, then of course there is no way that you can separate it completely. But the major thing is that they are looking at safety, but of course, we do understand that they look at survival as well.
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