Replies to post #799364 on NorthWest Biotherapeutics Inc (NWBO)

[skitahoe]

Diver,

With the Hub and Spoke arrangement, could an EDEN unit be certified prior to supplying it to the spoke agency, or would it need to be done on site, perhaps as part of the training process.

I was of the belief that the concept was intended to be able to move EDEN units around, as needed, as long as qualified personnel was at the spoke agency receiving the EDEN. In some cases it might be an additional unit or two, but in others it might be one unit that isn't needed full time.

As I understand it, the units are roughly the size of a computer printer, they ought to be easily packed and shipped. I would think that all units would come from and be returned to FlaskWorks to verify they're ready to be utilized again, not shipped between agencies needing them.

Gary

[jimmy667]

Thank you, Iwassadiver for putting an end to that trubulent noise. It was tortured and convoluted pseudo-reasoning that seemed only designed to be irritating. NWBO approval maybe very near. 

[barnstormer]

Welcome back Diver, it's been a while. Your post makes the most sense, and is consistent with an earlier post from Slave1 to the effect that the MHRA can process the original MIA process described in the MAA and the type ll variation adding Flaskworks simultaneously. Looking forward to the approval of the former. Hope you'll continue to drop in and contribute.

[sukus]

Great info Doc. Thank you. Once again the argument of the bears about FlaskWorks is proven wrong. Those bears some of them are very famous. They are so loud as if they know more than regulators. ;) ;) But with this post, what they said repeatedly about this automated device was proven to be wrong again. Not requiring clinical trial bro ;) Pretty cool.

[10baggerz]

Always great to see you post doctor diver!
I think you're analysis makes a lot of sense.Was wondering if you might care to opine about a couple issues that remain unexplained:
1. Why is the MAA review taking so long and why does the MHRA keep stating that the NWBO MAA is not part of any back log (and at one point that the MAA is "with the company") 
2. Simarily, why did GZ's email keep referring to the fact that frequent interactions between NWBO and the MHRA really only started after the MHRA MAA backlog was cleared on 3/31/25?

3. Why has NWBO not submitted evidence to NICE? Could this imply that they need to wait until the Type II variation is approved before filing for NICE reimbursement (maybe this is why NWBO was listed on the NIH high cost drug list for all cancers so early, to give everyone the opportunity to get funding prior to waiting on)?

[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

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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

[dennisdave]

Every key claim in your post is factually incorrect or based on assumptions that contradict MHRA rules and basic ATMP-CMC principles.
NWBO has never stated publicly that the MAA was filed on manual production. Claiming you “know” this is either speculation or implies access to material non-public information, which is not something you can cite as fact. Besides that companies have changed the intent to manufactur mid ATMP review all the time. You are being very ignorant, denying that I have provided a dozen examples.

ATMPs cannot be approved on a temporary bridge method. The commercial route must be validated before approval. NWBO’s own November PR states that Flaskworks/Grade C is central to commercial large-scale production. That automatically excludes manual as the commercial basis. A Type II variation cannot replace a non-commercial process. Variations can only modify an already-approved commercial manufacturing route. They cannot be used to convert an interim artisanal method into a commercial process.

The idea that “one GMP machine in a C-suite” is enough to justify the commercial process is wrong. ATMP commercial validation requires process validation, comparability, consistency, QC frameworks, and full Module 3 updates. Machine-level validation is not sufficient for an autologous cell therapy.
Sawston’s Grade C suite is not yet operational; the company explicitly stated construction + installation + validation still must occur. That is incompatible with the claim that a Type II variation is “well underway” or nearly complete.

If you want to accuse others of ignorance, at least start with an accurate understanding of MHRA procedures, ATMP CMC requirements, and what variations can and cannot do, all knowledge you completly lack. Nothing you wrote aligns with the regulatory framework. You are incredibly ignorant and not as smart as you think you are far from it

[dennisdave]

I couldn’t just let this one go because it’s too ignorant to not address

you were saying something about being ignorant? Tell the MHRA that

Thank you for your email.



We generally require that the commercial manufacturing process intended for the MA be fully qualified, GMP- compliant, and reflected in the Manufacturers License before the MA is granted.



MHRA will typically assess the updated process as opposed to the original, especially if the applicant intends to commercialise the new route.



Timeline impacts are usually considered clock-stops, not backlog.



We generally cannot grant an MA based solely on the original process if the applicant no longer intends to use it.



The MA must reflect the commercial manufacturing route.



Kind regards,

Aleena

MHRA Customer Experience Centre

Communications and engagement team

10 South Colonnade, Canary Wharf, London E14 4PU
Telephone [phone]