Vascular Biogenics Ltd (VBLT)

[davidal66]

I'm also confused a bit by the companies explanation. Enrollment is occurring faster than expected and--since it's randomized--about equal amounts of VB-111/Avastin versus Avastin, so I believe they're equally balanced. The problem 'may' be overall survival benefit in the open label study treatment arm versus Avastin. I'm not sure the company can comment on this further in public as the FDA decision awaits. Second, is the issue of the drop out rate. One of my worries was I saw two cases on the INSPIRE thread where the patents were randomized to Avastin only and immediately dropped out of the trial because they wanted VB-111 and then dropped out of the Avastin only--and are gunning for other trials. So, the other issue in eventing deaths that might be problematic if you have an imbalance b/w the two groups(not because of deaths or events), but because of drop outs. Dror--the CEO--commented this is no longer a problem.

So the two potential pitfalls is event timing and two will drop outs of the Avastin only arm complicate matters. Bottom line: the more time passes by with the more events taken into consideration, these issues are less important. I also believe the company wants more events to hit the predetermined endpoint of stopping the trial. Just my 3 cents on the matter.