Replies to post #611057 on NorthWest Biotherapeutics Inc (NWBO)

[Foogie88]

then that is plain ridiculous or stupid to present it that way

[CrashOverride]

I agree flipper44. Too many think we are late when in fact Linda Powers, who wrote NAFTA and EU Patent Law, has logically, in my estimation, put us on rolling review. The magnitude of this application will only be understood once we get approval. I guarantee the ASCO 2023 proteomic analysis, which proved Mechanism of Action, was included in the application as regulators in my opinion must have this data. That was likely a hundred pages or more including appendices. These things simply take time. Thankfully we have laser-focused management and diehard shareholders who are steadfast in their support of this monumental effort. From my perspective no number of degenerate spoofers or manipulative swing traders will derail this upcoming Landmark approval.

[DJPele]

Is 1.7 million pages typical for a specific drug approval? Also, if we are not granted rolling review, could approval be a considerable ways away with these many pages and modules?

[antihama]

I guess Smith on Stocks has a direct line to LG eg 1.7M pp

[hankmanhub]

At 27 modules and 1.7 million total pages,

I assume that as 1.7 M pages is much larger the the usual submission, then it follows that 27 modules is much larger than usual as well. Anyone know how many modules the typical submission contains? If for example the answer id say 20 modules, then we have 7 extra modules. (my math is very good).
My question is, what would be the substance of these say 7 extra modules?
1) due to the diff requirements of the several RAs?
2) to account for tissue agnostic?
3) to account for EDEN?
4) to account for the addition of rGBM?
5) to account for solid tumors?
6) to account for Direct?
7) to account for the many possible combos, in particular those trials already underway?
8) to treat DCVAX as a platform?
9) to account for ECA?
10) to help lead up to any of the above to ease future trials and lighten their submissions?
11) For any combination of the above?
Clearly something is happening here, even if we are only actually applying for GBM in the UK.
Any ideas?
Whatever the answer to the above we really seem to be on the one yard line this time. Can't be long now!