Replies to post #776440 on NorthWest Biotherapeutics Inc (NWBO)

[learningcurve2020]

Again, NO, it states that NWBO states that it is. Why can type correct that?

>>NICE letter states that NWBO is still fully occupied and engaged

[seekinganswers]

"that remaining step is almost always the finalisation of the SmPC."

This could not possibly be further from the truth.

There are literally dozens of reasons why this app has been held up for 18 months.

[AllSheWrote]

The bottom line is that you don't know jack s--t about the status with either MHRA or NICE, but that doesn't slow you down in the least from spewing wild conjecture about things to which you are not privy.

[FeMike]

it’s usually because they can’t refute the actual argument.

I've refuted the argument. That you refuse to acknowledge that your thesis is absurd and unfounded, leads me to the conclusion that you are simple minded.

The July 15 NICE letter states that NWBO is still fully occupied and engaged with the MHRA and not yet in a position to submit to NICE

Again, this is the exact same position that NWBO was in last month. Last quarter. Last year. Absolutely nothing has changed. You cannot use this evidence as facts that NWBO has received approval and are in labeling. Something has to have changed for you to surmise that they have advanced from review to labeling. Nothing has changed. The fact that it's been in review for a long time doesn't justify this thesis in the slightest.

What you are basically saying is that NWBO has received approval "because it's been a while".

This is not about AI or speculation. It’s about process. NICE cannot legally begin appraisal until it receives a draft or final SmPC. That’s outlined clearly in their published guidelines (PMG24). The language in the letter matches that point in the sequence exactly.

This can all be true. It's not, but for the sake of this argument it can be. It being true doesn't prove DCVax-L is in labeling. It could still be in review. Towards the end of review? Sure, probably hopefully. But it still being in review does not discount anything in your statements from being true.

[georgebailey]

This is important and for those following Mayo's clinical trials and how very similar their process is to NWBO's Direct.
ASCO June 2019
Guess what, Mayo is running a trial with Direct- Thanks Andrew C and Slave.

https://nwbio.com/highlights-of-nw-bios-program-update-in-the-industry-expert-theater-presentation-at-asco/#:~:text=included%20the%20following%3A-,DCVax%2DDirect,DIPG%20trial%20is%20in%20the%20process%20of%20FDA%20review%20and%20clearance.,-DCVax%2DL%20Phase

[FeMike]

The July 15 NICE letter states that NWBO is still fully occupied and engaged with the MHRA and not yet in a position to submit to NICE. NICE also says they are awaiting further contact. That confirms the MAA is active and that the company hasn’t reached the handoff point. At this late stage of a review, that remaining step is almost always the finalisation of the SmPC.

Here is what I want you to answer for me slAIve

These 'confirmations' were true exactly one month ago.

NWBO was actively engaged with the MHRA, and they were not in a position to submit the evidence package.

Why, one month ago when these circumstances were true, were they not approved and in labeling? Two months ago? What has changed in the past month that these statements now confirm approval/labeling, when they did not mean that one month ago? Is 18 months post submission not considered "this late stage of a review" but 19 months post submission is considered "this late stage of review"? What milestone has been hit?

Let me break it down for you another way since you are slow. These are the parameters you are basing your thesis off of:

March 15th, 2024: NWBO is actively engaged with the MHRA, cannot submit evidence package, MAA under review
September 15th, 2024: NWBO is actively engaged with the MHRA, cannot submit evidence package, MAA under review
January 15th, 2025: NWBO is actively engaged with the MHRA, cannot submit evidence package, MAA under review
March 15th, 2025: NWBO is actively engaged with the MHRA, cannot submit evidence package, MAA under review
May 15th, 2025: NWBO is actively engaged with the MHRA, cannot submit evidence package, MAA under review
June 15th, 2025: NWBO is actively engaged with the MHRA, cannot submit evidence package, MAA under review
July 15th, 2025: NWBO is actively engaged with the MHRA, cannot submit evidence package, these two facts mean that the MAA is now approved and in labeling

Sooo....what am I missing? What has changed beside the date? Is your conclusion purely based on your belief that "surely, this can't possibly take any longer"? You must tell me what else has changed besides these "facts" you've laid out.

[FeMike]

Hey Buddy, still waiting on you to answer this for me. Is Grok a little stumped with this one?

Here is what I want you to answer for me slAIve

These 'confirmations' were true exactly one month ago.

NWBO was actively engaged with the MHRA, and they were not in a position to submit the evidence package.

Why, one month ago when these circumstances were true, were they not approved and in labeling? Two months ago? What has changed in the past month that these statements now confirm approval/labeling, when they did not mean that one month ago? Is 18 months post submission not considered "this late stage of a review" but 19 months post submission is considered "this late stage of review"? What milestone has been hit?

Let me break it down for you another way since you are slow. These are the parameters you are basing your thesis off of:

March 15th, 2024: NWBO is actively engaged with the MHRA, cannot submit evidence package, MAA under review
September 15th, 2024: NWBO is actively engaged with the MHRA, cannot submit evidence package, MAA under review
January 15th, 2025: NWBO is actively engaged with the MHRA, cannot submit evidence package, MAA under review
March 15th, 2025: NWBO is actively engaged with the MHRA, cannot submit evidence package, MAA under review
May 15th, 2025: NWBO is actively engaged with the MHRA, cannot submit evidence package, MAA under review
June 15th, 2025: NWBO is actively engaged with the MHRA, cannot submit evidence package, MAA under review
July 15th, 2025: NWBO is actively engaged with the MHRA, cannot submit evidence package, these two facts mean that the MAA is now approved and in labeling

Sooo....what am I missing? What has changed beside the date? Is your conclusion purely based on your belief that "surely, this can't possibly take any longer"? You must tell me what else has changed besides these "facts" you've laid out.