NorthWest Biotherapeutics Inc (NWBO)

[biosectinvestor]

That is false. It was approved prior to data lock and the final date is also before data lock. The SAP’s final date, though it was prepared by an external, third-party firm, is prior to data lock. It’s not post hoc and this has been said repeatedly by numerous persons and third-party researchers. The final date is close to date lock, but I have given you previous indications showing how many years it was in process ahead of data lock. The final date is likely a function of when the last regulator signed off on it, not when it was drafted. But in any case, the final date is before data lock,

The dates you have given are fictional.

The discussion goes back some time before this discussion, when we as shareholders discussed it with management:

From the front page of this forum, annual shareholder meeting notes by IKE from 2019, also addressed in 2020 ASM, but this is clear enough, and you can find the link on the main page:

Question #10: Is there ongoing dialog with the FDA regarding formation of the SAP and will you wait to unblind until after the SAP is approved?

Answer (LP): "Definitely 'yes' we won't unblind until the Statistical Analysis Plan has been approved by all regulators. FDA and other, four regulators. We intend publicly as a company policy, which is pretty standard for companies, we don't talk about our communications that are ongoing with FDA or other regulators. We only say results, so I can't comment on interim communication type things, but in case there is any [lack of] clarity about remarks earlier about the SAP, it is an actual submission to the regulators. Like when you apply for an IND, that's Initial New Drug, application to get a clinical trial approved or when you apply to get a new product approved. You make an actual submission to get your SAP reviewed and approved."

Of course investors were anticipating the revised SAP long before that ASM in 2019, and I had argued with people that doing it with 4 different regulators so that it would be exactly the same, would take a long time and be extremely complicated, despite beliefs otherwise by numerous other well regarded posters, who thought it would happen within months, maybe half of a year. From experience with cross-border regulatory hurdles, I knew it would be challenging to ensure it was the same result and consistent. They often are quite independent and it takes a lot of back and forth by their lawyers before finalizing, typically, with multiple country circumstances like that where regulations are often not ExW tly the same and the applications may need to be simultaneous and in different languages even perhaps.

And the date of the final SAP, as I said, is just before the data lock, September 23, 2020, likely indicating final regulatory sign-off. Then data lock.