Vascular Biogenics Ltd (VBLT)

[memeil26]

Technically all study phases examine safety. Phase I trials examine only toxicity of the drug but on a small number of people. Phase II is about efficacy and safety and phase III is basically to show efficacy and safety with enough statistical power.

In this case the DSMC is also reviewing for efficacy, if the study wouldn't show any advantage over the control group, the DSMC could just suggest to terminate the trial. however since this may still be too early to tell, we should just wait for another few months for the interim results to show up.

With a bit of lack if the interim results may be powered enough to show efficacy, FDA can approved it before top-line data, but that is a big if for now.