Monday, June 26, 2017 9:24:44 AM
Charles Duncan
Good morning, guys; first of all, congrats and progress in the quarter, and thanks for taking our questions. Dror, I wanted to ask you couple of questions about the GLOBE program in GBM. The first is regarding this recent data safety monitoring committee review. Could you confirm whether or not that was just safety review or was there an efficacy component to that, and what specifically were they look at?
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.
Charles Duncan
And then going on to the -- the trending of the first real efficacy interim, I think you mentioned 105 deaths or 50% of patients having six month follow up, whichever is later. Your perspectives on timing, is that primarily driven by good clarity on the 50% having six months follow up, or are you tracking at least on a blinded basis the number of deaths. And I know it's not a blinded trial, so what gives you confidence about the timing of that interim?
Dror Harats
So first everybody should understand that we are completed blinded on the data. And we have no way to know much on the data and that clearly is only the data monitoring committee that can take look at the data. And we insist on being completed blinded and we never try or allow anybody to tell us anything different that can hint anything. We know when we recruited patients and of course we know when we are going to get to the 12 months follow up of half of the patients. And that's not going to happen before Q3 2017. And therefore, we know that the interim will be at that time. Because we were recruiting ahead of time, we could expect to have more deaths earlier. It's not happening so far and we are looking at we have care that's -- is according to what we hope and expected. It does not mean anything and I want everybody to be very careful about it. But we know now that the interim won't happen before Q3 2017. Now the cut of date will be at the certain date in Q3, and of course it takes couple of weeks or up to four weeks to analyze the data. So we know that we won't be able to talk about interim analysis before the second part of Q3 2017. And we wanted to actually let the market know that that's a situation as we know it, right now, because the study is progressing and we have more information.
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