Northwest Biotherapeutics Inc (QB) (NWBO)

Regulators don’t care about a paid presentation by company’s CTO and that too if a regulator is going to be from another country and the CTO/company is presenting in a small, local market (not even an international/global meeting). Abstracts/posters, and such paid presentations are different. Don’t mix them up and get confused, LOL! ;)

You are calling it a strawman, but then you concede the key point.

“NWBO is not changing its trial dataset. What it is doing is a different external control analysis.”

Exactly.

That is what I am asking about.

I never said the external control data had to be collected at the same time as the DCVax-L trial. I said the patient level matching variables had to exist, be accessible, and be usable.

If the subject data was “not previously available but now is,” then the question remains: what data, from where, controlled by whom, made available when, and was this new external-control analysis submitted to MHRA?

PSM does not create patients. It selects or weights comparable patients from an available dataset.

So “new comparison data is available” is not the answer. It is the issue.

If NWBO is now using a different external control analysis than the one originally relied upon, then the obvious question is whether this was optional support or whether the original external control analysis needed reinforcement.

Why not? If they're about to launch in UK, why not talk about it with the people who will be giving it to their patients? Plus, the abstracts presented at this meeting will be published in BNOS's journal in a few months. And, once presented, the contents of the presentation can be shared more widely by PR or on their website. You think they should give it to an RA (or two) but not tell anybody else about it?

In that case, why present to the neuro oncology community in the UK? LOL! ;)

If the original SAP/external control analysis was already sufficient, why spend time and money pursuing comparative data

What if it has less to do with the RA they already filed with and more to do with an RA they have not yet filed with?

Again with the strawman arguments, oh and quibbling over terminology.

Yes PSM is a method and yes it requires data to feed that method. All of that was assumed in this conversation because it is obvious.

There is no requirement for PSM data to be time matched, as in acquired at the same time frame as the trial it will be used to analyze.

What is required is patient matching in terms of disease state, treatment history, age and other relevant demographics, or as you refer to them as the right matching variables.

NWBO is not changing its trial dataset. What it is doing is a different external control analysis. Yeah, that's right. Comparing the trial data against another data set that now is comprised of PSM subjects. Subject data that was not previously available but now is.

What changed? New comparison data is available, which surprisingly enough allows for new comparisons i.e. statistical analysis.

This is not that hard.

LINK
$NWBO

Brazen22 is exwannabe. After 12 years exwannabe signed off. And Brazen22 took over.

Beautiful cloaking.

It's just that he/she/it acts and writes rhetorically same way and obviously has a negative take on everything.

Thanks for your service.

Ass hat.

Rot in hell. pic.twitter.com/OtNBOshnWD— 🇩🇰 The Danish Dude 🇬🇱 (@FlemmingBruce) June 17, 2026

Don't know if this is true, but maybe Brazen22 can let us know.

First, PSM is not data.

PSM is a method used to match DCVax-L patients with comparable patients from an external-control group.

To do that, NWBO would need suitable patient-level external-control data with the right matching variables.

That is why NWBO’s 2022 statement matters. They said PSM was not feasible with the available data. The likely reason is that the necessary patient-level external-control data was either unavailable, inaccessible, or not usable for matching.

If the needed variables were never collected, they cannot be created years later.

If they were collected but not accessible, then the question becomes who had them, how NWBO gained access, when that happened, and whether that new access was submitted to MHRA.

And if NWBO changed the dataset or matching approach, then that is not simply “PSM data became available.” That is a different external-control analysis.

So “now feasible” is not really an answer.

It raises the real question: what changed?

You are great at creating binary arguments when there are more than two possibilities.
PSM data that wasn't available when the application was filed seems to have become available now some 2 years later. Things change over time. Regulatory environment changes, additional trials are run and those results become available for example.

PSM doesn't have to have been central to the MAA at the filing time and may not be central now. You seem to assume that it is.

PSM data being available may be additional support for the original application to answer questions that MHRA had concerning the original data.
If the original application was not sufficient then why has the MHRA not rejected it in the last 2 1/2 years. At the same time one could ask if the application was sufficient why hasn't the MHRA approved it in the last 2 1/2 years.

The point being that the application being is process for 2 1/2 years by itself does not lead to any specific conclusions. The time frame could be due to many different factors, none of which we have any information about.

One that that does seem to be clear is that the PSM data might support the strength of the response analysis that the previous trial data could not. We do not know which way that data affects the statistical analysis i.e. strengthen or weakening. What we do surmise is that it clarifies the results.

Now feasible is an answer to why PSM is available when it wasn't earlier.

That does not answer the question of what result that PSM data has on the trial response analysis.

If the original SAP/external control analysis was already sufficient, why spend time and money pursuing comparative data that NWBO previously said was unavailable?

And because it's not just about regulatory approval in the UK. It's about reimbursement, approval with other regulatory agencies, prescriber confidence, etc.

If the original SAP/external control analysis was already sufficient, why spend time and money pursuing comparative data that NWBO previously said was unavailable?

If you need a C to pass a class, why expend effort to get an A?

If your current job pays a salary that is sufficient to pay your bills, why expend any effort to get a more meaningful one that pays more?

They filed the MAA with the best they had. Now, after the passage time and the development of opportunity, they have something better. Why wouldn't they spend time and money to do that?

Yeah, an excuse presentation? So, if denied they can point to what should have been used (and considered) and that they were unjustly denied after 2 1/2 years. Maybe just providing cover....

Maybe the reason we are getting a PSM update instead of a Flaskworks update is because NWBO spent its scarce resources addressing the evidence problem, not the manufacturing story.

brazen22,

Enrolled to the point “statistically necessary” leaving 17 SOC/placebo patients out said Fraunhofer in their 2015 annual report. “Bump in the road” said Mr. Neil Woodford and that this bump had something to do with advancing the program to the clinic. It was 2014 when NWBO first contacted the professor at Northeastern University who would start the development of Flaskworks. We need a Flaskworks update!; ). Best wishes.

Doc, I am not back to label discussions. I am asking what is actually in the MAA and what evidence supports your explanation for the delay.

“Minimum prepared for, more possible in the mix” is exactly the problem. That sounds like inference, not disclosure.

If Flaskworks is the key point to work around, then the threshold question remains: is Flaskworks part of the current approval basis, or is it a post-approval transition plan?

If it is part of the current MAA, that seems material.

If it is not part of the current MAA, then it does not explain why the existing application has remained unapproved for roughly 2.5 years.

And I do not think “take your pick” solves the issue. If Flipper thinks the delay is mainly comparator/statistical and you think it is mainly manufacturing transition, those are very different explanations. Both cannot simply be treated as proof that approval is inevitable.

The one thing I agree with is that the MAA appears to be getting slow-walked. The question is why.

Maybe it is manufacturing. Maybe it is comparator/statistics. Maybe it is both. But the public signal from Bosch’s upcoming PSM survival-analysis talk points directly back to the adequacy of the clinical/statistical case.

As for joining the crowd, I will join when MHRA does.

Until then, the issue is not who on iHub agrees approval is inevitable. The issue is why MHRA has not approved it.

LessIsMore,

Yes, NWBO did pay for a platinum sponsorship this year at BNOS 2026 for Dr. Bosch’s presentation, but DCVax-L was presented by Dr. Ashkan as part of the scientific program at BNOS before too, and he won an award for that presentation. The 2022 presentation was mentioned when he was awarded MBE a few years later:

“His work on brain cancer vaccines received the top presentation award by the British Neuro-Oncology Society in 2022 and promises to impact the care of patients with brain tumours worldwide.”

2026




All foregoing comments relate exclusively to the topic of Northwest Biotherapeutics and its stock. Statements are made in the context of public discussion and are directed solely at the content of claims, forecasts, or interpretations presented therein. Any emphasis in tone or phrasing is used solely to highlight discrepancies, inconsistencies, unsupported conclusions, or areas where additional substantiation may be appropriate or requested in furtherance of the discussion. Nothing herein is intended as commentary on any individual participant, identity, or posting alias.

It’s pay to play. The conference organizers
would give a 30 min presentation slot to any company that would come in as a platinum sponsor of the conference.

Yup, it will indeed be a nothing burger. In fact, I predict the stock will go down the week after the presentation.

It’s high time to show me the money and not go on an endless quest to justify their data, 6 years post data lock and no reimbursement submission in the only tiny jurisdiction they applied at.

This will signal to the market that UK decision is many months away and that even this data is not convincing enough. Otherwise MHRA would have approved by now. And they would have submitted evidence to NICE as well. Expect it to be a long summer, LOL! ;)

A fart in the wind?

Maybe. But enough methane in the air can still change the climate.

The bigger question is whether July 3 is really the regulatory moment some people are pretending it is.

If Bosch’s PSM analysis is material to the MAA, then MHRA most likely already has it. Regulators do not need to wait for a sponsored conference talk to discover evidence that should be in the application record.

So if this PSM analysis is supposedly strong enough to change everything, the obvious question remains: has MHRA already reviewed it, and if so, where is the approval?

The panic question is not mine.

I am not the one depending on a July 3 conference presentation to rescue a regulatory story that has already been pending for roughly 2.5 years.

at least the management is trying to get some visibility

I mistakenly thought that NWBO received an invitation and Dr. Bosch would be a keynote speaker and abstracts would be submitted for peer review.

That's how it's supposed to work.

This is another nothing-burger just like ASCO 2020, 2021, 2022, 2023 and 2024.

If the original SAP/external control analysis was already sufficient, why spend time and money pursuing comparative data that NWBO previously said was unavailable?

You don't commission a second appraisal if the first one already satisfied the lender.

A PSM analysis is not something a cash strapped, repeatedly diluting company would casually undertake for academic curiosity. It requires access to suitable patient level comparator data, statisticians, matching methodology, balance testing, sensitivity analyses, documentation, and time.

So if NWBO spent the resources to obtain comparative data and run a PSM analysis after previously saying PSM was not feasible, the obvious question is why.

The most natural answer is that the original external control survival analysis was not persuasive enough to end the regulatory debate, so NWBO is now trying to prop it up with a new PSM analysis.

Maybe the new analysis helps. Maybe Bosch presents something persuasive. But saying “the comparative data became available” does not answer the question. It opens the real question: who obtained it, from where, when, under what conditions, and was it submitted to MHRA because the original analysis was challenged?

Agreed. It’s not going to make any difference to the stock price or even open any potential partnerships. I tried to find out how much did the company have to pay to play here, but couldn’t find out the cost to be a Platinum Sponsor. I think there are at least two other Platinum sponsors. Also how much impact can a half an hour presentation create - short of concluding with “We hereby have proved beyond a reasonable doubt that we have a CURE for GBM in particular and cancers in general” ? - not much. That said, at least the management is trying to get some visibility. That is better than just sitting on their thumbs waiting for approval.

The BNOS Conference is another "pay to play" event from NWBO.

We are delighted to announce that our Platinum Sponsors will be hosting sponsored symposiums throughout the conference

Northwest Biotheraputics
Title: DCVax-L -associated survival extension assessed through propensity score matching analyses
Speakers: Dr. Marnix Bosch, Chief Technical Officer, Northwest Biotherapeutics

https://www.bnosconference.org/

IMO this is going to be another pumped nothing-burger.

Here’s a little something new but not much. 🤷‍♀️. No mention of any advancement beyond the trial. No mention of NWBO, interestingly.

And like I said yesterday, still no clue why it might work it some??

>>Trials on her idea began in 2003 and ran through 2019, with the results published in JAMA Oncology in 2023: Of 331 patients who got the vaccine, an impressive 20 to 25 percent were alive years later. Her research now focuses on why that subset of patients fared well, looking closely at their blood, cerebrospinal fluid, and even gut microbiome. One clue might be a biomarker called MGMT methylation that, generally, is possessed by those who fared well. “But nobody knows what the biomarker actually does,” admitted Liau.

https://www.brownalumnimagazine.com/articles/2026-06-23/brain-tumor-breakthrough-linda-liau

I absolutely agree

Submitted the MAA when they did because the EMA was finally out of the picture. 🤷‍♀️

Feels like another Saturday here. 🤷‍♀️

“I fully support this new initiative to increase the prompt publication—as required by law—of results information from interventional studies of the medical products we regulate,” said Tracy Beth Hoeg, M.D., Ph.D., Acting Director of the Center for Drug Evaluation and Research. “We hope that the thousands of messages sent to sponsors and investigators reminding them to publicly report their findings will improve patient safety and keep researchers and the public better informed of benefits and risks of new and investigational products.”

We can thank the current administration and its new FDA leadership for putting the screws to Big Pharma to release patient-level data from their clinical trials.

Thank you, Sentiment!

Could it be...
Another crappy day, week, month, year, decade, 1/4 of a century!!
P to the M!!

beazen22,

Right back to label discussions now aren’t we?; ). Minimum prepared for, more possible in the mix. Transition to Flaskworks still the key point to work around. Other issues solved along the way. Slow walking is what both flipper44 are in agreement about. He thinks it’s for the comparator question mainly and I think it’s to cover for manufacturing transition. Take your pick. What we both agree on is that this MAA will be approved. Care to finally join the crowd?; ). Best wishes.

“LP is not a saint, that much i know.”

— Agreed. A BS artist who lost hard earned money from 2 generation of hard working retail families and over a decade of opportunity cost.

but wherever they gathered it from, they have it.
… exactly.

“Now feasible” is not an answer. It is the start of the next question.
You sound like you work at the MHRA, lol.

its okay, he is learning, nothing wrong with learning😂

Great post, biosector. Thanks for that take down. :)

If propensity score matching was “not feasible with the available data” in 2022, but is supposedly feasible now, what changed?

The comparative data was not available then. The comparative data is available now. So what changed is the availability of the comparative data, which was previously unavailable, but now is available.

That raises the next obvious question.

If propensity score matching was “not feasible with the available data” in 2022, but is supposedly feasible now, what changed?

There was no new DCVax-L Phase 3 trial. No new randomized control arm appeared. So did NWBO obtain new individual patient level comparator data? Did the external control dataset change? Was this new PSM analysis submitted to MHRA? Was it accepted?

And if PSM is now central to the MAA, why would it take more than 2.5 years after submission to figure out how to do it?

That is the problem. Either PSM was not part of the submitted approval package, in which case Bosch’s talk may simply be methodological and not approval relevant, or PSM became part of the regulatory argument later, which raises even bigger questions about why the original package was not sufficient.

“Now feasible” is not an answer. It is the start of the next question.

Ant meets rubber tree plant.

That’s correct. The big boys wouldn’t open up their data for NWBO in 2022, but by 2025/2026, NWBO obtained propensity score matching data from somewhere. My guess is they probably at least incorporated the control arm from SurvaxM 2b, which was enrolled under the new definition of GBM, but wherever they gathered it from, they have it.

And that raises the obvious question: if all of those issues had to be solved before approval, why did NWBO submit the MAA when it did?

A marketing application should mean the company believes the evidence, manufacturing package, quality controls, and launch readiness are mature enough for regulatory review.

But under your theory, more than 2.5 years later NWBO still may not have the manufacturing transition, leukapheresis capacity, reimbursement clarity, cash runway, CDMO capacity, or launch economics needed to support even a controlled launch.

That does not explain the delay in a way that helps NWBO.

It suggests either NWBO applied before it was ready, or the “manufacturing launch window” explanation is being used after the fact to rationalize a delay that has another cause.

“not feasible with the available data” - May 10, 2022
'now feasible with the now-available data' - July 3, 2026

The way it looks now, we may not hear another word until August 15th 10Q. It's got to be criminal. WTF

Oh we'll get one more PR, no worries.

On July 2nd, with the market closed at 5 PM (or on July 3rd at 8 AM after the presentation has already been given), we'll get the following press release:

NORTHWEST BIOTHERAPUETICS ANNOUNCES UPCOMING PRESENTATION ON DCVAX-L TRIAL RESULTS DISCUSSING PROPENSITY SCORE MATCHING ANALYSES

Northwest Biotherapeutics (OTCQB:NWBO) (the “Company” or “NW Bio”), a biotechnology company developing DCVax® personalized immune therapies for solid tumor cancers, announced that Dr. Marnix Bosch, its Chief Technical Officer, will make a presentation on “DCVax-L -associated survival extension assessed through propensity score matching analyses ” at the upcoming British Neuro- Oncology Society Annual Meeting. Dr. Bosch will address certain factors and combinations of factors that impacted extended survival of trial patients receiving DCVax-L.

The presentation will take place on Friday, July 3rd at 10 AM BST. The slides will be posted on the Company’s website after the presentation.

But other than that, yes you are correct. Highly unlikely we'll get actual news before the next Q.

brazen22,

DNDN had money and the ability to produce profitably with sufficient volume and proper management focus because they had FDA approval which meant higher reimbursement rates were available. This meant manufacturing costs were not as big of a problem even for making one batch at a time. They failed as a business anyway because of management decision making.
Everything with NWBO points back to manufacturing. If too much demand then manufacturing must be addressed so expansion is required ie increase dedicated leukapheresis capacity and manufacturing space ie CDMO contract put in place vs delayed Class C clean room readiness. If it costs too much to produce for amount received from reimbursement even with restricted label-manufacturing but can be produced near break even for a while then cash flow bleed must be managed really well. This also requires that manufacturing transition be in place or failure would be expected due to ongoing financial constraints. Without this, there would be very little price support from those seeing the situation clearly and that includes potential partners. DNDN did not have those initial concerns.
NWBO has shares, not cash so those shares need to be sold judiciously during the pre revenue period with enough left over after any approval to sell at a higher price for actual commercial scale operations and that includes the initial cash outlay to make vaccines until reimbursement monies get back to them. The high upfront costs, rate and speed of reimbursement, timing of manufacturing transition and other concerns must all be addressed before launch AND find the right window of time to launch just like a space launch. Best wishes.

Bosch won't say "we should have used this strategy but didn't?" NWBO already stated they couldn't use it.

NWBO previously stated that propensity score matching was “not feasible with the available data” in its May 10, 2022 presentation.

https://virtualtrials.org/dcvax/dcvax.pdf
page 17 bottom of item #4

No volume. No updates from the company. MHRA pushes inquiries back to the company. No clean rooms. No partnerships. No FDA application. No new trials.
And now everyone is on the edge of their seat waiting for Bosch to speak in 10 days. What happens when that is a non event or even worse, what if he says we should have used this strategy but didn't? Or is MHRA refused it?

The way it looks now, we may not hear another word until August 15th 10Q. It's got to be criminal. WTF

Does that number include the dogs and cats?