Replies to post #1135 on Vascular Biogenics Ltd (VBLT)

[wcopeland]

No, Valueinvestor12, I do not think that DSMC's report will stop the trial for early approval. Also, they have probably achieved both 105 deaths and 50% with 12-month data by now. I imagine they would be given a few weeks to perform the interim analysis, so if their interim would have coincided with the DSMC report, the interim trigger likely happened. That said, skipping the Ph3 interim is really weird. How often does that happen?

Gr8, I agree, I think things are all positive still. Longer survival is likely attributable to VB111. If patients in the Avastin arm are living longer, it is probably because they drop out of the trial in favor of some other treatment rather than Avastin extremely outperforming. I would guess it would be nice to do an analysis of concurrent rGBM trials.

[Oren1976]

I published this response in seeking alpha and I think it may represent the options we have although of course I can be wrong

And one big thing I forgot to mention. If you check last pr and conference call earning you will surprised to hear that FDA decided to cancel futility analysis. Very weird , I never heard of SPA FDA trial that they decide to cancel futility analysis. It was suppose to happen in September 2017. Celdex tried a drug in ph3, did the FDA cancel futility ? No. Bristol Myers and much bigger company than VBL did they cancel futility ? No. actually I don't remember even one case that FDA decided to cancel futility analysis and jump directly to the top line data.

I am asking myself why did it happen here are the options:

First I tell you what it is not, it is not that VB-111 working great. If it was working so great they would say lets do futility and in the futility they would announce they stop the trial because VB-111 is doing so well. so this is not the case. VB-111 struggle with rgbm it is not winning in knock out

So what could it be ? and why the market took the stock from 4-5 in few days just because FDA cancel futility ?

1. It can be because the FDA is lazy like me. It can happen. Why to do futility now if we are so closed to the end of the trial BUT in order for this reason to be valid VB-111 must be a bit better or not less than avastin, if vb-111 was doing less than avastin they would never press the laziness button

2. They are not lazy but they see something. They see that VB-111 helps only to small group of patients but it helps them so well that the MRI show very small tumor and maybe even lack of tumor while in the avastin group they don't see anything but same as historical activity in the MRI. so they see that if they do futility now it is not fair for the drug and it shows the FDA is doing all they can to approve VB-111 and right now the way to do it is by canceling futility hoping the small group will live so long that it will affect in a positive way the top line data. A clue to that option we have in the last PR of the company if you look at the earning PR they speak about the long term effect of VB-111 look how many time the word long term is in the PR. It is an EYE wink from the fda and the market understood this clue by fda and company talking about long term survival by VB-111

So anyway I look at it we have here a drug that FDA is doing everything possible to approve and when the power decide to approve it who am I or you to decide ? They approved avastin only because they wanted to and it seems they want to approve VB-111