Replies to post #668825 on NorthWest Biotherapeutics Inc (NWBO)

[manibiotech]

Now you can understand why SP is where it is without any ongoing communication

When was the last time you saw a govt agency change so drastically from Dec to Jan

[manibiotech]

And look at the graph… median days have been increasing every month last few months of 23 all the way till Dec , and suddenly they will take a nose dive in Jan
Sure

Also see number of pending products awaiting as of end of last year

[flipper44]

So here is my layman’s understanding. I could be wrong.

UK will dramatically unclog their independent review queue if companies approved in other jurisdictions shift their 2022/2023 maa applications over to MHRA’s International Recognition Program. This started January 1, 2024.

My hypothesis is that the independent “swift approval process” might be getting introduced as of January 1, 2024 as an as yet unrevealed hyper accelerated program, and is running pilot cases through its process at this time.

My hypothesis is that NWBO lined their application up to be in pole position (perhaps then getting chosen for swift approval process). My hypothesis is NWBO intentionally concurrently applied at the exact time Advent’s HTA license was granted/renewed after manufacturing inspection, and Advent’s commercial license was freshly granted just nine months earlier when the funding came in. See below.

The “swift approval process” along with the IRP included 10,000,000 pounds of funding, and I surmise most went to IRP (international review program) for more staff, but that by unclogging the independent review tract, this also benefitted the “swift approval process” where expert veteran teams can see through a high impact therapy application from start to finish.

In other words, IRP has freed up the U.K. independent accelerated processes.