Northwest Biotherapeutics Inc (QB) (NWBO)

How do we even know if the guy who replied knows about intricacies of the application? I think the "manufacturer" he's referring to is NWBO. That's it.

Hey norisk, i hope you are diversified, despite my 600k+ shares of nwbo my accounts just like the market have hit another all time high.
Ceo LP needs to give an actual update, either has a real chance or need a new trial

OK, Mr. potty mouth.

I apologize for my potty mouth and aggression.

FeMike,

Yep, that makes sense too and your example does demonstrate the unwritten and assumed modifier ie manufacturers (of DCVax-L). Best wishes.

Fair enough. I've heard Yanks also use it that way.

JTORENCE,

Comparability!; ). Someone might want to know if DCVax-L can be made comparably the same at another location and maybe with a different method than Advent’s/NWBO’s on site MIA certified commercial scale location. Best wishes.

Meirluc, if you’re saying that they will approve w artisan method (which I agree with) than my bad and I am confused but I don’t think you’re saying that. If you’re saying they will wait for approval w the C suite then you’re wrong. I’ll wait to see your response before responding.

Nope. That’s not it either.

It’s just how that turn of phrase is used in that particular application, especially in the UK.

It would be more appropriate (though still different) to think of it this way:

“Great Britain is proud to announce their sponsors for everything: Shell - refiners of oil and gas; AstraZeneca - producers of pharmaceuticals; Rolls Royce - contractors for aerospace and defense systems; and Advent - manufacturers of DCVax-L”

Yes, they’re taking a chance. But it’s the least bad option for anyone sitting on legacy synthetic exposure. Closing out over time isn’t possible when the float is locked, borrow is thin, and every uptick forces mark-to-market pain. Their only viable strategy is delay.

If approval hits, or a BP deal materializes, or the lawsuit lands in NWBO’s favor, the problem for them isn’t “losing profit.” The problem is forced reconciliation, which mens synthetic exposure has to be delivered, swap obligations have to be unwound, fails and locates have to be cleaned up, inventory mismatches get exposed. That’s why they suppress sentiment now — because once a catalyst hits, they lose control of the tape.

A BP deal brings real buyers with real size, which blows out any containment strategy. Approval creates institutional demand and removes the uncertainty they rely on. The lawsuit validates the entire pattern of trading behavior and forces discovery they absolutely do not want. Yes, they’re gambling. But from their side, delaying/waiting is safer than trying to cover into a thin float with a binary catalyst ahead. That’s the whole play.

What happens when DCVax-L is approved, NWBO wins the lawsuit, and a BP partners with NWBO?

Yes, but there is a bunch of carryover from May, and a bit from April. Plus, didn’t we just get 7.5 million from somewhere? While it looks good there is some excess on the averages. Thanks for continuing to share these numbers! By mid July if nothing much, game on!

I just remembered something. It’s not a British thing. Americans do it, too. For example, when we say, “I’ll be at the doctor’s.” It a reduced form of “doctor’s office”. So, the writer probably just spelled it wrong by leaving out the apostrophe. Cheers.

Confirmed no dilution was reported throughout last week. Based on today's volume (1,412,437), my expectation is that today will also be a no-dilution day, but we'll reassess once the data is available tomorrow.
It appears there was no dilution reported last week, although I'll verify the outstanding share count again on Monday. If confirmed, this would be the first week since February 2026 with no reported dilution.

Monthly breakdown:
June 2026 (to date): 5,032,241 shares (1,674,579,694 - 1,669,547,453)
May 2026: 31,330,471 shares
April 2026: 21,740,923 shares
March 2026: 17,732,625 shares
February 2026: 7,853,985 shares
January 2026: 22,808,837 shares

Total Dilution (2026 YTD): 106,499,082 shares
Current Outstanding Share Count: 1,674,579,694 shares

Manufacturers......Of course more dot connecting ......where does that ever lead you idiots

OK, Mr. potty mouth. I didn’t use AI. I’ve taught English grammar for 30 years, including being a principal at an Industrial Training Center for Saudi Aramco in Saudi Arabia, so I know what I’m talking about. Any Brit who says manufacturers but means manufacturer wouldn’t be replying to email inquiries for MHRA. That sounds more like a drunk soccer fan at a World Cup venue, or you I guess.

Couldn’t manufacturers mean Advent and Sawston/NWBO ?

That’s how British people talk, dumbass

Stop relying on AI

You keep saying the same things over and over and they are still not based on any evidence other than your faulty logic.

Repetition does not mean something becomes true.

That's how I read it as well

That’s not true. Maybe you are confusing the fact that ‘manufacturer’ can be used not only as a countable noun but as a collective noun, too. Using a collective noun, one could say ‘manufacturer is’ or ‘manufacturer are’ depending on if the group or the individuals wish to be stressed. Both are correct. But ‘manufacturers’ with a final -s is plural in both American and British English grammar. The only other option is that it might be a typo. Finally, in the context of the email, it couldn’t be a misspelled possessive adjective (‘manufacture’s) where they left out the apostrophe because it’s not followed by a noun. Hope this helps you.

I don’t know, Deepash uses the word in the second response to TheFollower. I don’t see that as interchangeable as you do, but what do I know. Maybe he was in Deepesh Mode? 🙂

Anyway, here is Google AI.

The MHRA does not use these terms interchangeably when evaluating a Marketing Authorisation Application (MAA). They define distinct legal and operational entities in the pharmaceutical framework.Here is how the MHRA differentiates them:

1. Sponsor Role: The individual, company, or institution that takes responsibility for the initiation, management, and financing (or arranging the financing) of the clinical trials.Focus: Clinical development, trial oversight, and regulatory compliance during testing phases.

2. Manufacturer Role: The entity or licensed facility that physically produces, packages, or tests the drug substance and the finished medicinal product.Focus: Strict adherence to Good Manufacturing Practice (GMP), quality control, and release specifications. Manufacturers must hold a specific Manufacturer’s Licence (MIA).

3. Company / Applicant (MAH) Role: A broader corporate term for the entity that submits the MAA and will ultimately hold the Marketing Authorisation (MA). Once approved, this entity is known as the Marketing Authorisation Holder (MAH).Focus: Commercial stewardship, ongoing pharmacovigilance (safety monitoring), and liability for the medicine once it is on the market.Why the Distinction Matters in an MAAWhile a single corporate group can technically act as the sponsor, manufacturer, and MAA applicant, they are legally and functionally separate in the eyes of the MHRA. During an MAA evaluation, the MHRA meticulously reviews whether the Company (MAH) has established adequate contracts and technical agreements with its approved Manufacturers to ensure quality control, and whether the Sponsor's clinical data meets safety standards.

Good afternoon everyone. This morning there was a post that said someone on NBC would be reporting on a new treatment for brain cancer. I watched it
but did see anything. Does anyone know if they actually made a report? Thany you. Peace Reg2015

I’ve said in the past, that you can not believe in a higher power and do what these people do. Their day of reconning is not going to be pleasant.

Guess nobody here is that old. LOL

The phrase "and subsequently reach patients as rapidly as possible." can be interpreted to mean the overall process being completed as rapidly as possible.
That, to me, seems the most likely meaning.

Desperation - because they don't have other good options. FDA told them not to bother and the U.S. is the only developed oncology market that marketers make money -- it subsidizes virtually all the other markets. NWBO could have done the U.S. with contract manufacturers requiring nominal capital.

Getting approved in the U.S. is the only good choice but NWBO's dubious trial revisions violated FDA guidance and closed that door. That's why they didn't file in the U.S. and likely won't ever until they do another trial.

NWBO can't afford to market in the UK as NICE pricing would likely require NWBO to subsidize any volume and they will lose money which they can't afford. That's how single payer markets work.

Without ILT's guidance I'm completely lost

I was just pondering on this, I've so missed updates on how much our stock is worth on the LSE and our weekly renewing targets for the floodgates opening.

I feel it's likely they used manufacturers and sponsor interchangeably. 

ChatGPT:

In regulatory language, “manufacturers” very often refers broadly to the company developing and submitting the product — essentially the sponsor/applicant organization — not just the literal factory or production staff.

Lol you mean LSE guidance from that moron? Hahhaa

DoubleJ23 Hey genius, when they say manufacturing, they mean NWBO in general and not signaling that it's the manufacturing reviews the that's holding up the application.

I’m gonna have to agree with you, that does not seem boilerplate, at least not 100% of the time I’d reckon.

Without ILT's guidance I'm completely lost

Hahahaha oh wow that site is both hilarious and sad. LP paying some rando to have an AI trash community hub.

Thank You OPennyS. I got a friend who works at a hospital in MD that says they have a surgeon who specializes in cryotherapy. I will likely consult with him after urologist, but I will mention that to him also. I am travelling to China later and will probably get an opinion there also. Looking at all options. I asked if I can keep my hair and consultant said yes, so I got that going for me. Spain not impressive in their first game. I will put my money on Germany.

Making things up still?

I've been wondering if since the company PR'ed the construction, were they legally obliged to PR the cancellation?

They should have been, in my opinion. But Powerless has somehow never found herself to be constrained by the shackles of what society would define as "legally required".

I got a recording of a conversation that probably happened between Linda and Dave in November last year.


Powerless: "Dave, be a dear and release a PR about how we are starting construction on Grade C manufacturing clean rooms"

Dave: "Are we starting construction on those? That's great news! I was under the impression we couldn't afford it right now."

Powerless: "Oh, heavens no. We definitely can't afford that, can't even afford to have a real engineering firm out to give us an estimate on building those. Still recovering from the $4 million I gave my BFF for those awful Flaskworks designs"

Dave: "So...should I not issue that PR? Seems misleading..."

Powerless: "David, please, I pay you to redirect my calls, not to think. Like I said put out a PR saying we are starting construction. If it bothers you that much, you can bring a tape measure to Sawston, measure the back wall, and say we are only starting construction "activities". We can toss a one liner into the financials in a few months about pausing it for some reason or another, nobody reads those anyway. They'll forget about it just like they forgot about restarting DCVax- Direct. You see, I'm tallying the ASM votes right now and we need a few more to comfortably approve our salary. OUR salary, Dave, you understand yes? We're in this together, after all"

Dave: "Ah, right as always mum. I'll get right on that."

The sentence you bolded certainly reads as if manufacturing is where the application currently resides and that they are working through the requirements, which implies this will be approved afterwards. I think this is a very positive statement.

I've been wondering if since the company PR'ed the construction, were they legally obliged to PR the cancellation?

If only this market would go higher

FIFTEEN YEARS AGO!!!

“NWBT highlights cost effectiveness of DCVax in view of recent immunotherapy pricing concerns”

https://www.thepharmaletter.com/biotech-news/nwbt-highlights-cost-effectiveness-of-dcvax-in-view-of-recent-immunotherapy-pricing-concerns

Remember this one? Just search “DCVAX” on this site and look at all the implosions.

“Several parties interested in Northwest Biotherapeutics' immunotherapy cancer vaccines”

https://www.thepharmaletter.com/pharma-news/several-parties-interested-in-northwest-biotherapeutics-immunotherapy-cancer-vaccines

It could have meant additional data from the original trial and that could have been part of the delay 2 years ago, I don't see any relevance to current delay other than the fact that is should be worked through by now.

And, with all of the inquiries and responses by MHRA staff on this MAA, isn't it defeating the argument of staying silent so as to not upset the regulators? Maybe the MHRA will tell the company to update it's shareholders so their staff stop getting bombarded by neglected shareholders.

Danish keeping the memories alive. LOL. To his credit, the site is tens times better than the company raising hundreds of millions of dollars. 🤷‍♀️🧐

Here LP talks about taking eleven years in the making and that was now eight years ago! Can’t make it up. Talking about how the rumor is the product will never be viable because of the cost and LP saying that’s false and absolutely not the case…eight years later.

https://www.nwbo-community.com/vault/2901ea49-78bc-4281-8342-b5b978b691bc

“Clinical trials data,” to me, at that late stage, with the time that has passed, likely means an additional control arm, like that from, perhaps, SurvaxM 2b.

This can be due to the need for further documentation and/or clinical trials data, as well as other such considerations. — MHRA

"manufacturers" plural, interesting...

It's not interesting, it's British.

That's not 'plural' for them.

Again, it seems to me, NWBO would absolutely have an internal projected leuk clinic opening (fully licensed) date. They just don’t want to share it.

If they haven't decided to pause that project as well, and are simply waiting on the next Q to inform us lowly shareholders.

That is quite a standard.

If I should be punished for asking questions, what should happen to those who are actually responsible for the delay?

The application is in MHRA’s court, and NWBO is responsible for proving safety, efficacy, manufacturing quality, labeling, and the overall benefit-risk case.

If NWBO has proven all of that, then what explains MHRA’s continued lack of approval? If NWBO has not proven all of that, then why blame critics for pointing to the uncertainty?

"manufacturers" plural, interesting...

Another response received:

Thank you for your email. We have information on the medicines approval process on our guidance page along with a video presentation:
https://www.gov.uk/guidance/national-assessment-procedure-for-medicines

The MHRA 150-day rapid approval process applies to medicines that fulfil the criteria for this scheme. Some products may be submitted via this route but ultimately cannot be approved in this way. This can be due to the need for further documentation and/or clinical trials data, as well as other such considerations.
As you can appreciate, we are unable to disclose the exact status of the DC Vax application, but please be assured that our authorisation teams are working closely with the manufacturers to progress this as quickly as possible.
We hope this information is helpful.

Kind regards
Deepesh
MHRA Customer Experience Centre
Communications and engagement
Medicines and Healthcare products Regulatory Agency
10 South Colonnade, Canary Wharf, London E14 4PU
Telephone 020 3080 6000
gov.uk/mhra

Stay connected
For information on how the Agency uses your personal data and your data protection rights, please see our three centres’ Privacy Notices: MHRA, CPRD and NIBSC.

Yeah, isn’t that something? Chicken and the egg.


Also SickDude at it again. At least he apologized.

https://www.nwbo-community.com/news/56a5f9b9-116b-44f6-8b5b-f2f8686ca424