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Jumpinjackas

09/15/17 11:36 AM

#1215 RE: Oren1976 #1214

You seem confused! You say June in one post and Jan or Feb in another!

"189 events and 75% of patients get treatment 12 month can happen in November . U assume it happen in January but it's an assumption. If u listen to CEO not long ago he spoke about top line end of year or just at the beginning of next year. CEO also assume 60-90 days to calculate the stats and still says q1 18 knowing that even if cutoff was Nov 17 the pr will come only Jan or Feb 18"

-vs-

oren1977
@Jackash @bigmit2011 @Steelcity2 the results may be delayed even to June 2018 considering 90 days to analyze top line data
oren1977
@bigmit2011 @Steelcity2 it won't move until around March 2018

staccani

09/15/17 11:37 AM

#1216 RE: Oren1976 #1214

From the latest conf call dated Aug 14th:
'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