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staccani

09/25/17 1:04 PM

#1322 RE: gr8db8 #1320

Sorry but you are missing the point here.
Safety analysis does NOT include efficacy analysis. They will not report efficacy analysis as they will not do an efficacy analysis.

Safety of course includes seeing who is experiencing adverse events including deaths and why and if this is due to treatment, but it is something completely different from efficacy review.
Based on safety analysis DMSC can only recommend trial early stop due safety, but not to efficacy.

So if trial continues as I think, this will not tell us anything about VBL111 efficacy. VBL111 could be very effective and yet will not and cannot be stopped now for efficacy.