It is in the last conference here what Dror said:
Dror Harats
So thank you very much Sara, and actually that's a very good question. The DSMC, whenever they meet I guess the full non-blinded data for safety and of course part of the safety is a number of additional mortality, which of course look for safety reasons. But because our primary endpoint is overall survival and the number of deaths actually, so they look at efficacy on each time. So far they looked at it twice and gave us a green light to go forward; actually in April, and that's why we came with a press release at that point, because it's not just safety, they’re actually looking at the primary endpoint of this each time that they are looking at the data.
They felt that we don't even need the phone call and we suggest now that everything looks great and we should go forward. And later on when we discuss DSMC meeting that we are -- that they are going to have in the third quarter, in September, actually we had called to discuss this and they told us that everything looks quite right, and we should go forward. What they’re going to do in the meeting, in September, they're going to get data which is going to be cut -- the cutting date going to be sometimes in August. But of course, you have to make sure that the data is relatively clean.
And then they look at the data where they get listing and tables that include all the safety issues, but there also includes the survival of the two different -- includes the number of tests of the two different cohorts. The cohorts that’s getting VB-111 with of Avastin and the cohort to control arm that getting just Avastin. So of course, it’s not a formal efficacy look but whenever they look, they look at efficacy. The only difference between formal survival analysis, which actually or utility analysis, which was planned for this time, but unfortunately or fortunately, because we recruited patients ahead of time, it will actually almost clash with the end of the trial is that when you do a formal futility analysis you have to clean the data the same way that you do when you look at the data at the end of the trial. And that usually take about 60 to sometimes 90 days and that’s going to clash actually with the end of the trial and closing the data. And therefore, in the discussion with the FDA, it was clear that the way to do it is the regular look that the DSMC going to look. But they will have all the information. And of course, you’re saying we’ll see any alarming safety or mortality data, we will know about it right away.
