Replies to post #921 on Vascular Biogenics Ltd (VBLT)

[wcopeland]

@Value

Declining an SPA is very confusing, and I am still trying to figure out why they would do that. I will listen to the CC as soon as it is available for more insight. However, I do not think we will ever really know until Dror makes it known. Here is an interesting article for perspective:
https://www.forbes.com/sites/johnlamattina/2014/12/01/should-the-fda-force-drug-makers-to-discuss-their-clinical-trials/#7489f1b37489

One possibility: The FDA's SPA came with a non-ideal trial design. For example, the question has come up many times about why VB111 was paired with Avastin for rGBM as opposed to going against it head-to-head. Maybe the ultra-conservative FDA is forcing VBLT into a Ph3 ovarian trial design that they truly believe is sub-optimal.

As for using VB111 off-label, if it has been approved by the FDA, I imagine that doctors could do so for ovarian in the same way that they might do it for thyroid. I guess at that point it just comes down to available options.