NorthWest Biotherapeutics Inc (NWBO)

[longfellow95]

Senti.
I think you may be forgetting PFS adjudication.
They wouldn't be going to such great effort to do that, if they had already given up on PFS as the primary endpoint.
If they intend to hang on to PFS as the primary endpoint, then that will necessarily be the primary focus of the SAP (though ably supported by the OS long tail data) and will require the blinded data from the completed PFS adjudication.


We just don't know, because there was no mention of PFS, or endpoints at all, at the ASM.

And this Board seems fixated on how long it takes to rewrite an SAP. Well, it depends what you are going to put in the SAP.

If it takes two months to rewrite an SAP and a year to do the PFS adjudication, and the adjudication necessarily has to come first, then what is likely to be the delaying factor; the adjudication or the SAP rewrite?

On the other hand, they may indeed give up on PFS and try and make the case that OS is so exceptional that that alone should form the basis of the SAP. And indeed the eventual BLA.

I can't engage in whether we are 3, 4, 5, or 6 months away from unblinding, because it may depend on the time it takes to do the PFS adjudication, before the result of that, can go in to a finalized SAP.
Nobody knows.