Replies to post #802796 on NorthWest Biotherapeutics Inc (NWBO)

[jesster64]

"I believe the first meticulous review is standard setting for other regulators to approve expeditiously"
yes, for GBM. But you have been pushing the narrative its going to be for all cancers. So I would think review for ALL cancers might just take a little longer than just GBM. How's that for common sense?

[AllSheWrote]

Yeah, I'm sure that's what it is.

[beartrap12]

Yes, ilovetech! In fact, NWBO said in a PR, explaining why they needed to get everything right in this application to the MHRA, that they needed this application to be the best it could be because they would be using it to apply to other regulators.

[HappyLibrarian]

The UK is a first world nation correct? NWBO submitted 1.7 million pages and 27 modules, and answered every question that came up under a two year review. I believe the first meticulous review is standard setting for other regulators to approve expeditiously.

MHRA knows that each RFI they make has a measurable cost in lives but their hands are tied because folks who work in government like their jobs and to keep them comfortably they have to follow written and unwritten bureaucratic rules to avoid problems.

MHRA staff like bureaucrats anywhere will be cold blooded enough to kill a certain number of patients by doing the expected number of RFIs to cover their backsides, even if NWBO’s application makes the questions redundant. Mavericks who buck the system and ask why we are doing unnecessary things tend to leave government.

At the same time, ‘doing too much’ is a good way to get in trouble in government (MPs are already asking questions about the delay). Thus it is highly unlikely that MHRA staffers are worried about how NWBO will fare with the FDA and are not going to do extra work on that account or kill UK residents with GBM on that account.s. Thus

What is more likely, (if the story about the contractor screwing up in Fall 2023 is true) is that NWBO had to patch up the application to MHRA but knew delaying forever was not an option and so they did what they could while still technically submitting it in 2023.

While the application was not necessarily fatally flawed, it probably had so many issues that MHRA could not just do the expected number of RFIs to adequately CYA.

The most likely scenario falls between what you are saying and what Nemesis and his ilk are saying and in life the truth is generally somewhere in the middle.

The above is my opinion as to what is most likely causing us to basically be two years with no approval even in the UK.