Replies to post #399666 on NorthWest Biotherapeutics Inc (NWBO)

[anders2211]

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.

The final rule in 42 CFR 11.10(a) also defines "study completion date" for a clinical trial as the "date the final subject was examined or received an intervention for purposes of final collection of data for the primary and secondary outcome measures and adverse events (e.g., last subject's last visit), whether the clinical trial concluded according to the pre-specified protocol or was terminated…."

The question is thus when was the last patient was examined or received an intervention for purposes of final collection of data for the primary and secondary outcome measures. Im pretty sure that was at least on Aug 19

https://nwbio.com/nw-bio-announces-completion-of-further-data-gathering-for-phase-iii-trial/

BETHESDA, Md., August 19, 2020 – Northwest Biotherapeutics (OTCQB: NWBO)(“NW Bio”), a biotechnology company developing DCVax® personalized immune therapies for solid tumor cancers, today announced that the remaining outstanding clinical trial data for the Company’s Phase 3 trial of DCVax®-L for Glioblastoma brain cancer as described in the Company’s last report on July 24, 2020 has now been completed by the specialty analytics firms. With this data now in hand, final quality control checking and confirmation are under way to enable Data Lock.

I have already filed a complaint with the NIH