NorthWest Biotherapeutics Inc (NWBO)

[flipper44]

I understand most of your sentiments except the last. I think RK brought up the fact that the protocol type of statistical analysis could be subject to change. Regardless, if they have not unblinded, it is not only smart, but recommended as appropriate to reassess the SAP upon a final blinded look. The FDA has draft guidance from 2011 that essentially anticipates a long tail, and that it must be treated differently, because the impact is delayed and/or non-proportional. That said, they were supposed to have had a draft SAP for review ready by early/mid summer. Everyone figured out, imho, by this point, even if they had buy in from the regulators slightly before November 6, 2019, there was no good reason not to wait a few more weeks until the last enrolled patient's data crossed four years. That (aka: November 6) is now in the rearview mirror. If Dr. Boch was accurate, then the last four months has involved dialogue with regulators and any necessary adjustments to achieve "buy-in."

In other words, imo:

1. January to about July 2019 = Draft SAP completion.
2. About early July, 2019 = presentation to regulators.
3. Thereafter until now dialogue and adjustments (if possible) to obtain "buy in."

I sincerely do not believe your argument about the ability to draft a good final SAP could be done without utilizing later blinded data -- how much later data is arguable, however. I don't think modifying the SAP, in and of itself, is suspicious.

They simply are taking far too long, and their "pedal to the metal" and additional money would not speed this up quickly turned to poor us, we're too small....

They need to clarify their timeline. Publicly.