Vascular Biogenics Ltd (VBLT)

[davidal66]

Any thoughts on what exactly beating futility at the interim actually means?

It's my understanding if a drug doesn't hit futility the interim, that it means the drug is unlikely to hit the primary endpoint of the trial--to see a clear separation in overall survival events b/w VB-111 and Avastin. Dror notes the interim is more meaningful here b/c 50 % of the patients will have undergone potential 12 months of study drug / or 105 events, which every occurs later.

But I wonder what this means in concrete terms? Can somebody give some examples to qualify/quantify with an example or two? I also wonder how much information the company will be given at the interim analysis.

My guess on the timing would be mid to late July would be the 50 % potential 12 month threshold; that with a accelerating enrollment, mid to late July would mark the threshold wherein 50 % potential 12 month threshold would be met.

For example, if there is no separation of the curves with an equal death rate in both arms, I would assume the trial would be stopped for being futile to continue. But what if there is a 1 month separation between KM curves? I wonder what the threshold for what is futility actually is.