NorthWest Biotherapeutics Inc (NWBO)

[dennisdave]

1) Saying that NWBO's failure in general to not update the US clinical trial registry is not the subject is odd. The issue being asserted is if NWBO is required to update it. I know they do not.

Its not, the subject/your assertion is/was this (in my own words):
NWBO is legally required to disclose the amended SAP/endpoints. They did not therefore they have not submitted to the FDA (your assertion).
If you want to change that to NWBO is required to update the clinical trial registry, then I agree they are. However, you may be surprised but to all general rules there are exceptions and § 11.44 d.3 is an exception to § 11.64 (a)(ii)(A) hence the words "in general" in § 11.64 (a)(ii)(A).

2) Is about "primary completion date", not results submission. They are unrelated. The primary completion date was known months prior to Oct 5, 2020. This was a required update in one month having nothing to do with results submission.

I have trouble understanding of what you are writing here. In general, for applicable clinical trials subject to § 11.42, clinical trial results information specified in sections 402(j)(3)(C) and 402(j)(3)(I) of the Public Health Service Act (42 U.S.C. 282(j)(3)(C) and 42 U.S.C. 282(j)(3)(I)) or in § 11.48, as applicable, must be submitted no later than 1 year after the primary completion date of the applicable clinical trial. www.law.cornell.edu/cfr/text/42/11.44#b_1

And like I said NWBO clearly missed that deadline, but it has some and at the same time little to do with the subject/your assertion about amended SAP

3) This one can be argued. But the protocol change was publicly known to patients. Does that count as communicated?

No the protocol chance has officially never been disclosed by NWBO and has even been denied, but you know that. When in Oct 2020 it was discovered by posters here via the EMA website the database had already been locked so even unofficially there were no more trial patients to communicate anything to about the trial.