Friday, September 15, 2017 11:37:03 AM
'Top-line data after the occurrence of 189 events are expected in early ’18 based in interaction with FDA. And given our SPA agreement, the VB-111 GLOBE study should be the only trial we need for BLA and approval'.
From the official clinical trial: Estimated Primary Completion Date:
December 2017 (Final data collection date for primary outcome measure).
https://clinicaltrials.gov/ct2/show/NCT02511405
Even if we assume December as the month of the 189th event, the reasoning does not change much. We are talking about 17.5 months (ca 77 weeks) average duration with 25% survival vs ca 16-17% average of ph2 VB111 and historical BEV.
If BEV confirms historical survival then at 77 weeks we should have ca 15% and VBL111 plus BEV would show 35% survival
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