Vascular Biogenics Ltd (VBLT)

[memeil26]

Hi David, I believe when FDA reviews data of a new investigation drug,
it's much effort is by looking at the risk/reward to the patient.
So from what we know and can tell at this point:

1. The drug sounds to be very safe, when compared to other drugs in the market treating cancer in general terms.

2. The reward may be - for extending the life of those patients or - by improving the life of those patients - or both. by how much? it's a relative term and I believe it's unfortunately a subjective one (where p-value is below 0.05).
In fact the p-value is not what worries me at all where here much more patients had been enrolled compared to the phase II trial, or whether vb-111 is less effective to control arm. What worries me is how far this shows superiority because - it's a subjective decision made by the panel and it's members.

As I'm looking at it, an improvement of at least 35% in OS will not raise any questions to the panel when conditioned to show similar safety profile as seen previously.
Less than 35% improvement does not say to me that the panel will not approve the drug (we're still looking at the worst form of cancer and the stage of it) but chances will be reduced from the 100% depending on the actual results.