NorthWest Biotherapeutics Inc (NWBO)

[Umibe5690]

The trial is unblinded. No one knows anything for certain until unblinding takes place. So why would they re-write the SAP and continue the trial even now while "progressing" toward data-lock?

As LP has emphasized at the ASM, they have many experts and stats people advising management. They have much more info than shareholders do. So we can only speculate.

I believe the reason for re-writes and delays is that the primary and secondary endpoints likely have not been met. Their experts are advising them that the ball game is played with long tail and milestone OS. That is where they must hit the grand slam such that approval is undeniable. While in their discussions with the FDA the importance of these latter evaluative criteria take greater importance when considering immunological therapies, the FDA will look at the totality of the data with, of course, no guarantees on the weighting of the various factors involved when considering approval.

The foregoing, it seems to me, is the most likely reason. It does not necessarily point to failure if the primary/secondary endpoints are not met but it is critical that OS milestones/long tail and its composition provide undeniable results.

It should also be noted that long tail data is important for NICE/QALY and that DCVAX is at least as good as Optune but with added benefit of QOL and long term survival.

Based on that, odds for approval with a better reg environment, are quite favorable. I would not bet against it.
JMHO.