NorthWest Biotherapeutics Inc (NWBO)

[FeMike]

“NWBO reports that it is still fully occupied and engaged in the Marketing Authorisation Application (MAA) process with the MHRA.”

That confirms the file is open, active, and under engagement 19 months after submission. If there were deficiencies, a pause, or a reset, that would not be the language used.

This is true. Not debating that.

“The company are not yet in a position to provide their evidence submission with us and we await further contact from them.”

That sentence only makes sense if MHRA has not yet finalized the SmPC. NICE cannot review cost-effectiveness until the label exists. That is the final stage of the MAA process, and it only begins once the application is approved in principle.

This is sort of true. Nice cannot make a determination on cost-effectiveness until the label exists, but they can begin the review with the smpc draft and make a determination once they have the final smpc. But for the purposes of this discussion, we'll pretend this is true as you state it. You seem to be implying that because the label can only be finalized after internal approval, it means we have received said internal approval. We could still be waiting on internal approval, and thus not in label finalization, and thus still not (according to you) able to submit an evidence package to NICE. They aren't mutually exclusive.

The problem is, this is where the facts and evidence end. And none of that evidence proves (or even implies) that internal approval is done. You state:

But you’re pretending silence means nothing, when in fact it confirms that no further input is being requested.

You have no facts or evidence to support this. The company (and the MHRA for the most part) have been silent the entire process. So why now, 19 months in, does the continued silence mean no further input is being requested? It doesn't, you have no evidence that it does. Silence three months ago did not confirm no further input was being requested. Silence now does not confirm no further input is being requested.

You state:

There’s nothing more to wait for procedurally. The file is closed to new evidence. NICE is on standby. The SmPC is being finalized.

You have absolutely no evidence to support this. This is not a fact, this is your speculation based entirely on the fact that 19 months is longer than 18 months and you think 19 months is the arbitrary "this has taken too long, it must be approved" date.

Buddy, you are so out of your league in this discussion. It's quite comical.

But please, respond again and tell me why “NWBO reports that it is still fully occupied and engaged in the Marketing Authorisation Application (MAA) process with the MHRA" now means the application is approved when a month ago it did not mean the application was approved. I love this.