Replies to post #778410 on NorthWest Biotherapeutics Inc (NWBO)

[FeMike]

In that response, NICE confirmed that NWBO was still engaged in the MAA process and not yet in a position to submit their evidence. That statement implies the company had not yet received its draft SmPC, which under NICE PMG24 is a required component of submission.

The draft SmPC only becomes available after MHRA completes its internal review and enters the labeling phase. So it’s reasonable to infer that the labeling phase began shortly after July 15, likely between July 16 and July 20.

Oh my gosh you literally have no idea how this process works.

The draft SmPC is done. The draft SmPC is a requirement to submit the MAA - it is part of that package. The draft SmPC was done no later than December of 2023.

Stop, seriously. Just stop.

[Zadie420]

If we are in the last stage called "Labeling", can LP do a friendly memo to shareholders and inform where we are? If this is what you say is true, the PPS will shoot thru the roof and a lot of people who are waiting on sideline will jump in. Why not and since the PPS would be north of $1 then it would be less dilution. This is called common sense.

[exwannabe]

The draft SmPC only becomes available after MHRA completes its internal review and enters the labeling phase.

The draft SmPC was included in Module 1 of the MAA submitted in 2023.

[dennisdave]

Your post relies on assumptions and wishful thinking, plain and simple. Some parts are grounded in regulatory structure, like the role of the SmPC, but the leap from “NICE hasn’t received the SmPC yet” to “labeling began on July 16 and will end by August 13” is speculative. That timeline could be roughly accurate, or completely off if MHRA is still resolving a CMC issue, Flaskworks validation, or internal QP concerns.

You are
Claiming we're in the labeling phase now? Plausible but not proven.
Claiming approval must come by mid-August? Wishful thinking unless verified. I hope you are right and the SP gets over $1 and I can sell this turt
Citing PMG24 rules? That part is correct.
AI structured, but still speculation dressed up as inference.

[FeMike]

Hey Slave

It's about time to ask AI to come up with reasons this was 100% wrong. Curious to hear why this certainty isn't so certain.

Slave said:

While the MHRA doesn’t publicly declare when the labeling phase begins, we can triangulate it using the NICE letter dated July 15, 2025...it’s reasonable to infer that the labeling phase began shortly after July 15, likely between July 16 and July 20...Labeling typically takes 2 to 4 weeks...So as of today (July 28), we are almost certainly midway through the labeling phase, with final SmPC issuance, and NICE submission, expected within the next 2 to 14 days

This message was posted 16 days ago.

Weird we haven't heard approval news and NICE submission news since this information was almost certain.

[gwm61]

August 13th is history. When will the approval come? Let me guess. We have to wait until October 14th...

[FeMike]

Slave, you still refuse to respond to my request for a follow up regarding this post:

That gives us an estimated labeling window of:

Start: Between July 16–20
End (projected): Between July 30–August 13

So as of today (July 28), we are almost certainly midway through the labeling phase, with final SmPC issuance, and NICE submission, expected within the next 2 to 14 days, assuming no deferrals.

And remember folks. Slave wasn't guessing here. He said this was not speculation, and was a matter of fact. See his quotes below regarding this information:

Filings are where the legally reviewable facts live....the real story, not speculation, not forum noise....That’s not theory.... That confirms NWBO is currently in labeling. There is no contradiction here. No mixed message. No ambiguity once the structure is understood.

Let's stop falling for this guy's nonsense, huh?

[gwm61]

According to Slave's forecast, the labeling phase should have been completed by August 13. Shouldn't one expect approval to have been granted by now? The fact is, that's not the case. It would be nice if Slave1 could comment on this.