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Re: mantoo123 post# 1308

Monday, 09/25/2017 10:49:47 AM

Monday, September 25, 2017 10:49:47 AM

Post# of 2099
1) ca 50 patients were enrolled before June 2016 as stated in the following interview dated June 5th
http://www.onclive.com/conference-coverage/asco-2016/survival-in-recurrent-gbm-surpasses-historical-results-with-gene-therapy
2) ca 75 more patients were enrolled between June and Aug 2016 (as triggering the interim review in Aug 2017 hence reached 50% 12 months follow up)
3) ca 125 patients were enrolled between Sept and Nov 2016
4) ca 2 patients were enrolled in Dec 2016 (as stated in one conf call by the CEO when an analyst asked him when the enrollment was completed, confirming that basically the trial was fully enrolled as of Nov 2016)
Assuming BEV behaves as in historical data (and BEV historical rates are quite solid with more than 600 patients and also let us not forget that this trial enrolled patients also with big tumors so we should not see an improvement vs historical in BEV cohort) depending on when the 189th event is reached , we should have the following estimated survival rates in the two arms, at the cut off:

1) September ca 20% BEV vs 30% VB111
2) October ca 18% BEV vs 32% VB111
3) November ca 16% BEV vs 34% VB111
4) December ca 15% BEV vs 35% VB111
5) January ca 12% BEV vs 38% VB111

Hence VB111 should have already met the primary endpoint of significant survival improvement, also because CEO lately stated that results are expected in q1 2018 and no announcement about reaching the 189th event has been made yet.
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