NorthWest Biotherapeutics Inc (NWBO)

[Moose_Bite]

Hears' my take:

"What's likely going on here?" - They need more time to make sure they have all their ducks in a row regarding efficacy before they make their recommendation on that point. I expect at least a continue here as well or they would not have been comfortable enough to make today's announcement.

"Northwest Bio still hasn't told investors if the DCVax study is fully enrolled" - It's probably not fully enrolled at this point. GBM is a rare cancer and finding patients that are both qualified for and willing to participate in the study is not an easy task. While I don't worry too much about the enrollment numbers at this point I do wish the company would give some guidance as to how enrollment is going.

"nor has the company explained how or why FDA will be copacetic with a primary endpoint of progression-free survival" - I've done a bit of digging on this. Based on my own research it looks like the FDA is warming to using PFS as a basis for approval, especially in conjunction with OS as is designed in this trial. This appears to be most likely in cases where the condition being treated is especially deadly and existing treatment options are most limited. In addition recent publications in medical journals on this point indicate to me the there is growing support in the scientific community for broader acceptance of PFS. I'm sorry that I have no one black and white proof that it will be acceptable, but the sum of what I've found leads me to strongly believe it will be.