NorthWest Biotherapeutics Inc (NWBO)

[maverick_1]

GREAT POST & Thanks iwasadiver
& VALIDATING ONLY THOSE who POSTED the SAME recently

ONLY those who posted that MHRA Approval is NOT setback another 6 months is what REALLY MATTERS

VS the LAST DECADE of dealing with tons of NINKAPUTS

It should now be As clear as ZERO HUMIDITY ie re UTAH (HIGH DESERT or ARIZONA)

Since 2015 this has turned out to be an EPIC with lots of cascading damages
which is why MAESTRO has done what I advised:to be as clandestine as legally possible.

This EPIC has caused lots of cascading collateral damages

At least we now know the probabilities are increasingly LOWER for timetable changes for
BOTH Approval & it’sTiming

My EPIC Adventure (5+ mos abroad) is now delayed to Fall 2026:
*as the world’s highest highway at 4 miles high is closed &
*avoiding the ASIA Monsoon season

To fly & revisit China after 28 yrs
by touring vast China with a purchase of a BYD + SE Asia + Pyramids + Turkey + Greece

iwasadiver
Re: dennisdave post# 799284
Saturday, November 22, 2025 6:07:17 PM

Post# of 799398
I couldn’t just let this one go because it’s too ignorant to not address. NWBO filed an MAA [was BEFORE DEC 2023 SEE BELOW PRESS RELEASE]using the approved MIA process of grade B suites manufacturing by hand. The MAA will be approved for that process. A type II variation is required to use FlaskWorks machines. That work can be started before approval and has no effect or impact on that approval. In February of 2024 the company announced that they were embarking on the next steps to have a fully GMP compatible version of the prototype made.

In their recent PR this is the particular wording:
“ The Company's business plan currently envisions manufacturing being established in the Grade C suite in the Sawston facility during Q2 of next year, with the construction of the Grade C suite taking approximately 6 months, followed by equipment installation and validation.”

“Being established” means up and running. They then say the C suite should take 6 months followed by machine installation and validation. Validation has to be done on every single machine that is installed each time they build a new suite and add new machines. However, this is different, and much simpler, than the overall validation required for a Type II Variation request. After a Type II Variation is approved all new machines have to be validated individually. This is standard GMP manufacturing stuff.

I believe it’s likely they recieved a GMP quality FlaskWorks machine back in 2024 and Advent began the required studies/comparability steps, discussed this path with the MHRA, got their advice and guidance, and set about doing the batch reports, QA controls, and all the other steps required of a Type II Variation approval. All they need is one machine to be verified in an existing C grade clean area (which they already have). From that point they can apply for the Type II Variation and once they have this all they need is to validate each new C suite that come online, and each new machine that gets installed. These last 2 items would require only about 45-60 days. Further a Type II Variation request is confidential regulatory correspondence so this could be well under way, and close to finalized.

I’d suggest you do more research before you so confidently speak ignorance

Press Release
29
AUG
2023
Northwest Biotherapeutics Announces Completion of Prerequisites, and Plans for Submission of Marketing Authorization Application
For immediate release on August 29, 2023

BETHESDA, MD, August 29, 2023 – Northwest Biotherapeutics (OTCQB: NWBO) (“NW Bio”), a biotechnology company developing DCVax® personalized immune therapies for solid tumor cancers, announces that it plans to submit a Marketing Authorization Application (MAA) in the U.K., to the Medicines and Healthcare Products Regulatory Agency (MHRA)(the equivalent of the U.S. FDA), for commercial approval of the Company’s DCVax®-L treatment for glioblastoma.

The Company believes that it has now completed all of the remaining prerequisites for such an application, including certain steps related to implementation of the approved Pediatric Investigation Plan and submission of the required formal notification to the MHRA of the upcoming MAA. As the Company reported in its recent 10-Q filing, the Company is in the final stages of completing the application package itself.

The Company anticipates submitting the MAA in approximately the next 30-45 days. The Company plans to request that the MHRA review the MAA under the 150-business day process that the MHRA has established to accelerate the availability of new medicines for patients in the U.K.

Since the year 2000
Life in this world is exceedingly complex
We have been witnessing
The Severe Limits of Capitalism/Politics
AND The Beginnings of an APOCALYPTIC Era of Global Warming/Climate Change

SILVER PLATTER $TNXP@$12 Oct ‘24 https://t.co/B4KzARPmcT
BASICS IGNORED https://t.co/LorXfxv0cihttps://t.co/AAvVEmnbSR

10/11 Republican Recessionshttps://t.co/QSOa1TWmsF

Prepd 4 CHAOShttps://t.co/UWD8ijBgCwhttps://t.co/t9Gzi6aNXa

US sun SEThttps://t.co/C5O8BCSshl

— maverick_1 (@maveric92283613) August 13, 2025

DIFFERENT STROKES for DIFFERENT FOLKS