Vascular Biogenics Ltd (VBLT)

[gr8db8]

Some unusual (good) events so far for the VB-111 trial:

1) FDA encouraged/allowed ph3 to start before ph2 ended;
2) Recruiting was 5 months ahead of schedule; and
3) FDA allowed DSMC review and no interim.

None of these things change the mOS one way or another. On their own, we don't see each of these events happening often. But with this trial, all 3 have occurred.

VBL has limited resources so I don't see them having much influence over the FDA - compared to other biotechs - or focusing resources on making these events happen.

Item #1, the FDA must have seen something (durable responses?) that made them want to accelerate ph3. Hurry up and get this thing started!

Item #2, physicians and patients (who are much more savvy these days) drove this event, imo.

Item #3, again this is something the FDA allowed. I'm not so sure what it means .. perhaps the final data will reveal why this happened.