Northwest Biotherapeutics Inc (QB) (NWBO) Share Price

The trial was extended.

Nice has a timeline. We all know now, after it halted in 2018, there was a multi year break because NWBO decided to gather more evidence and design their SAP. Recently, LP stated they hired two consultants, approximately August 2024 imho, who began stage 1 reimbursement preparations.

DD every morning

Thanks, TDD

My last post, 80's here in the sunshine state and it's beach time.

Yes or no on your post below, were you wrong when you said this?

I don't think there are any signs the NICE schedule is off-track. Quite the contrary.

Yes or no, were you wrong?

I wish we would just fire the entire social media brigade and also save money on IR and simply input on the website that NWBO PR/IR has been replaced with ChatGPT

DD every morning tell me I am "Tell me I'm good enough, I'm smart enough, and doggone it, people like me”.

To me, appeal is not a “collaborative” process. To lessismore, it is.

Decide for yourself.

Here is the appeal process.

https://www.legislation.gov.uk/uksi/2012/1916/schedule/5/made

Note: On February 3, 2025, The MHRA stated to Muee in an email, after the likely 2nd CHM meeting, imo, that:

”As you have already seen, the company has announced that they have submitted their application to us. We are working actively on this application, recognising the impact this medicine could potentially have.

Finally, please be assured we a[re] progressing this application as rapidly as possible and in collaboration with the company.”

Investor082,

Really? Do you even read what you are writing?; ). Look I don’t begrudge you an opinion that revenue will be different that what I suggest because there are always things that can happen unexpectedly. However, to think that no patients would be dosed 6-9 months after approval when the manufacturing is being maintained fully operational for commercial scale production is beyond strained. Just considering expected doctor and patient demand along with the 2024/2025 NHS high cost drugs list with murcidencel on it that points to set aside funding being assigned for treatment suggests nearly immediate runs being made. Maybe you missed the importance of this; ). Best wishes.

it was obvious they would need to gather a great deal more evidence for QALY then they could have provided back in 2018.

dot dot dot dot dot dot dot dot

5 years later (2023) and still no evidence submission. You are a big part of the problem here, you just make crap up to further your agenda.

NICE in 2023:

National Institute for Health and Care Excellence (NICE)
From: nice@nice.org.uk
Wed, Aug 9, 2023 at 4:43 AM

I can confirm that no evidence submission was provided by the company, and we have contacted them on 24th May and 14th July this year and have yet to receive an update so unfortunately, there is nothing further I can advise you at this time.

Kind regards
Katy

The timeline started. It was interrupted while they met to discuss it. At some point, it was obvious they would need to gather
a great deal more evidence for QALY then they could have provided back in 2018.

Thats my girl. More dirt thrown in our faces, daily dilution.

It's almost DCVax-L approval decision time, but lie hub would make us think the decision has already been made.

"it's not going to receive approval with all these issues hanging over the trial. No way." [1]

"You know they will never get an approval on this trial." [2]

"…anything is likely except approval." [3]

"Odds of approval are about 5%, that is it." [4]

"I can go away tomorrow and the stock will still founder on the OTC while you idiots await the MHRA rejection…" [5]

"MHRA didn't agree to the 150 day approval - NWBO just begged for it. But here we are significantly past the 150 review window, so it's not happening." [6]

"REJECTION Mark this post" [7]

"There will be NO UK MAA approval for Dcvax-L." [8]

"And by the way, in my opinion, the MHRA is just taking their time, but in the end, they will likely reject it simply because it's from a tiny biotech and not from a big pharma company." [9]

"They will NEVER get approval." [10]

"If nwbo does submit in the UK, I expect it to be rejected." [11]

"This is going to get rejected no doubt in the UK." [12]

"Nwbo will be lucky to get p3 approval with MHRA…" [13]

Time to let this place to die!

There is a reason why NWBO is the top stock forum on a site with ~35k forums despite being a small OTC stock. On X, posters that spam misinformation are largely unseen, yet on lie hub these same posters are seen just as much as anyone else. On X you can block a nefarious poster who is then unable to post on your thread. On lie hub there is no such ability to block out the misinformation. This is why lie hub is full of posters 'with no financial interest' in NWBO that spend every hour of every day for years on end posting about how the company and the trial are a failure under the guise that they are 'looking out for retail shareholders'.

[1]Learningcurve2020 investorshub.advfn.com/boards/read_ms…
[2]exwannabe investorshub.advfn.com/boards/read_ms…
[3]robotdroid investorshub.advfn.com/boards/read_ms…
[4]scotty3371 investorshub.advfn.com/boards/read_ms…
[5]iclight investorshub.advfn.com/boards/read_ms…
[6]Hygro investorshub.advfn.com/boards/read_ms…
[7]Inquirig investorshub.advfn.com/boards/read_ms…
[8]Nemesis18 investorshub.advfn.com/boards/read_ms…
[9]Martydg investorshub.advfn.com/boards/read_ms…
[10]Sir pumpernickel investorshub.advfn.com/boards/read_ms…
[11]Jerrycampbell investorshub.advfn.com/boards/read_ms…
[12]Theorysuit investorshub.advfn.com/boards/read_ms…
[13]legend431 investorshub.advfn.com/boards/read_ms…

NICE has a timeline...but it was interrupted.

Interrupted LOL?

It was suspended because NWBO could not deliver an evidence submission, this submission is the first action item required from the applicant.

E-mail from NICE:

Our technology appraisal of DCVax-L for treating newly diagnosed glioblastoma multiforme [ID836] had started but it was suspended. This is because the company has informed NICE that, at this time, it cannot provide an evidence submission that is required for this appraisal. Therefore, we are suspending the appraisal while we hold further discussions with the company. We will provide a further update and rescheduled timelines in due course.

Meanwhile, our infamous dot dolphin spent weeks pumping the NICE timeline and it was literally days away from approval.

Look at the below post, "no signs that the schedule is off-track". All you needed to do was send an e-mail but why perform diligence when you can just make things up. You are unreal LOL.

Posts by you:

I don't think there are any signs the NICE schedule is off-track. Quite the contrary.

Anyway, the week 10 invitations are sent by NICE, and if they went/go out this week to patient and commissioning experts, then NICE must have received a week 8 data/evidence submission from NWBO (or their CRO). No real opportunity for bluffing, imho.

Nice schedule: Evidence submission by today. This is the last day one could conceivably call this mid-August.

People familiar with science know that real cures do not just jump out but are developed continually for years to decades, and typically longest for the more complex diseases. None are more complex than cancer when you consider the amount of resources invested in its study over many decades. We are slowly learning of the levels of complexity that lie within this simple disease name, cancer. How long has cancer ravaged mankind?

Your comment is rather unintellectual and not based on anything other than uninformed inuendo. I would say thanks for your comment but that would be as disingenuous as your comment.

GLTA

Hey Danish, thanks for dropping by. Hopefully you can edit your post cause I know you can't post again.

Please direct that response to XMaster. He's the one that said all 1.7 million pages had to be individually reviewed by 3 employees, and that is why the process is taking so long.

Seriously, I doubt they have a printed version, but think about the time it takes for 3 inspectors to go through 1.7 million pages.

My post was making fun of him for implying that is how the process works. I also posted this in response to him yesterday:
Think about the level of education it takes to understand that this isn't how the process works.
I know you are slow and it's hard for you to follow basic conversation, but please try to keep up before you make yourself look stupid again. You only get one post a day, after all.

At least you were able to use ChatGPT to educate yourself on the process before posting about it. It's weird that you needed it for something as simple as realizing that people aren't actually reading an entire 1.7 million page application, but still, good work, buddy.

Next you should go to ChatGPT and type in: "Please explain sarcasm to me"

LOL! Leave it up to all you numb nuts to ignore this. Absolutely cannot make it up! I’m sure you need time to all formulate a reply but it’s just a joke.

flipper44,

NWBO wouldn’t provide quality life years evidence while it continues to increase until they can get a reimbursement model that works properly for all investors or Linda would be sued for self enrichment through Advent if the majority of profits are going to them. This holds true, I believe, unless Advent is expected to be rolled into NWBO at or near the time of approval with an independent third party valuation involved. Building out a manufacturing site for a third but related party to maintain IP protection during the development period is one thing but to have a disproportional advantage with regard to profitability during commercialization is another that would be challenged. So the balancing act must be done with regard to NHS funding ability, NICE formula, and profitability structure for Advent and NWBO. This only really works with Flaskworks providing the cushion for all parties to find the balance which is one reason why I believe the market reacted strongly to the Flaskworks acquisition. Tricky, easily attacked but necessary even when approval is and has been basically a given based on the product performance itself (think Fraunhofer 2015 annual report). Best wishes.

Q for CharGPT:
Filing 1.7 million pages of info to mhra for maa application for dcvax-l, does that mean all of 1.7 million pages will be read?

A from ChatGPT:
No, the 1.7 million pages submitted to the MHRA for the DCVax-L MAA application does not mean that all pages will be read individually. Instead, regulatory agencies like the MHRA use a structured and efficient review process, which includes:

Electronic Review Tools & AI Assistance
Regulators use software and machine-learning tools to scan large documents efficiently, identifying key sections and flagging important areas.

Module-Based Review (CTD Format)
The Common Technical Document (CTD) format organizes submissions into modules, making it easier for reviewers to focus on critical data.

Not all documents need full review—some are reference materials.

Team-Based Parallel Assessment
Multiple specialized reviewers (clinical, non-clinical, CMC, pharmacovigilance, etc.) assess different sections in parallel, expediting the process

Rolling Review & Prior Knowledge
Since DCVax-L was in regulatory interactions before the final submission, some parts have already been reviewed or pre-assessed.

Previous trial data, compassionate use cases, and scientific advice meetings reduce the need for full reassessment.

Focused Review of Critical Aspects
Instead of reading every page, regulators focus on key efficacy, safety, and manufacturing data.

Reviewers can request clarifications or additional data if needed.

In summary, not all 1.7 million pages will be read line-by-line, but key data will be thoroughly analyzed using structured review methods.

Why do you think this?

FUD.

Can u guys just exchange numbers and take this offline

If I was on the review committee I would have read the Journal Article (JAMA) endorsed by 73 Coauthors which indicated Stat Sig. and I would consider the involvement of Kings College with DCVax-L and I would look at the Safety profile of DCVax-L. After 30 years without any movement on rGBM I would vote for approval!

If you were on the review committee, it would take you 15 years to read all 1.7 million pages of the package.

After approval it will all be clear.

They did a pretty nice PR on Roswell.

1) The PR on Roswell was garbage. People were (and still are) wildly confused about what that venture entails

2) They have since had two significant trial expansions at RP, and have not PR'd that

They stated the tech transfer has begun.
They put a blurb about this in a 10Q

My point is, the investing public has not been even close to adequately notified that these processes are happening, nor to the potential implications of these processes.

Toucan's bills aren't going to pay themselves

There has been no comments that would suggest rejection. If I was on the review committee I would have read the Journal Article (JAMA) endorsed by 73 Coauthors which indicated Stat Sig. and I would consider the involvement of Kings College with DCVax-L and I would look at the Safety profile of DCVax-L. After 30 years without any movement on rGBM I would vote for approval!

NICE has a timeline. They started it, but it was interrupted.

And I didn’t “pump” nice

You pumped NICE approval was imminent, maybe within days. You could have simply sent them an e-mail (like I did) but instead you connect dots, you always connect dots.

Wish to see some posts LOL? I don't think you do.

The UK and it's reiumbursement policies are not biotech friendly. But this point gets ignored by the pumpers.....Pump on. There is no path to real revenue in the UK. This is why very few go to the UK first if they are indeed trying to make revenue. But hey who cares about revenue....when CDMOs building are the real intent of this CEO.

Million shares a day ( work day) dilution and the cult is not worried about SP just waiting on approval. Its like the twilight zone or walking dead.

Appeal is an oppositional process. A denial recommendation is made and the company must argue against the findings with proof.

And I didn’t “pump” nice. NICE started the process then stopped it, because NWBO provided no evidence submission.

In the current situation, I believe the MHRA response, imho, means it is not an oppositional process, and that they are collaborating, you apparently believe otherwise.

Investor082,

According to you, you will sell and move on after the approval announcement. How are you going to be around to monitor anything?; ). Just in case you will still be watching because you think something else might happen and you don’t want to miss out please feel free to monitor sales; ). Best wishes.

Other companies that must appeal an MHRA process are not collaborating

Wow, you cannot be serious can you?

Do you realize that a rejection and subsequent appeal involves collaboration in regards to what steps must be made to appease MHRA?

smh this discussion is done.

Remember your NICE pump in 2018 (over 6 years ago), you never did admit you were wrong. How did that dot connecting work out?

We can show you dozens of posts if you wish LOL.

Unreal

They did a pretty nice PR on Roswell.

They stated the tech transfer has begun.

What’s your point?

It’s only a matter of time until Approval! Fortunately KG and his market makers friends burned their bridges with Trump when they shorted his stock. Great decision for us. Being the vindictive guy Trump is, I’m sure the SEC has their marching orders by now.
If I was a fudster I would be brushing up my resume and moving out of the country.
I believe LP was very astute in her decision to grow the company in the UK. Who knows what’s going to happen when Kennedy is in charge of the FDA. She is the perfect person for leading this company to success!

Outstanding Shares

02/05/2025 1,347,801,959 (+2,782,078 = 21,894,993 YTD)
01/30/2025 1,345,019,881
01/28/2025 1,344,203,554
01/27/2025 1,340,374,144
01/24/2025 1,338,534,125
01/23/2025 1,336,913,725
01/21/2025 1,335,098,031
01/15/2025 1,333,944,926
01/13/2025 1,329,625,491
01/06/2025 1,328,603,063

2024:
12/31/2024 - 1,325,906,966 (152,343,464 Full Year 2024)
01/03/2024 - 1,173,563,502

2023 Detail:
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=173492032

2022:
12/21/22 - 1,058,132,006
01/22/22 - 949,180,606

2022 Detail:
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=170751056;

Other companies that must appeal an MHRA process are not collaborating. Lol.

Since we like to rely on ChatGPT to solve all of our problems here, let's see what Chat's got to say about 10Q being appropriate for news releases:
Is news from a publicly traded company on the OTC exchange more likely to get more exposure from being published in its quarterly report or in a press release?
ChatGPT said:
News from a publicly traded company on the OTC (Over-the-Counter) exchange is generally more likely to get broader exposure through a press release rather than being published solely in its quarterly report. Here's why:

1. Audience Reach:
Press Release: Press releases are typically distributed through media channels, news agencies, and financial platforms (such as PR Newswire, Business Wire, or even through the company's website). These releases are designed to be picked up by a wide range of media outlets, including financial news websites, newspapers, and blogs. This gives the company a higher chance of reaching investors, analysts, journalists, and the general public beyond just their shareholder base.
Quarterly Report: Quarterly reports (10-Q in the U.S.) are primarily designed for investors and regulators. They're filed with the SEC and typically accessible through investor relations websites or financial data platforms. While investors and analysts will read these reports, they don't usually reach the broader public unless accompanied by media coverage.
2. Timing and Relevance:
Press Release: Companies often use press releases for time-sensitive news—such as product launches, mergers, acquisitions, or significant updates—because press releases are issued as soon as the news is ready, providing immediate exposure.
Quarterly Report: These reports are typically published on a regular schedule (every quarter) and may not always contain breaking or urgent news. The focus is on financial performance, which can sometimes get buried in a sea of other information. While quarterly reports may highlight significant events, they might not generate the same level of urgency or attention.
3. Visibility in Financial Media:
Press Release: Press releases are picked up by financial news outlets like Bloomberg, Reuters, Yahoo Finance, etc., which can lead to more significant media coverage. They are more likely to be cited in articles or mentioned in interviews.
Quarterly Report: While financial analysts may dissect and analyze the report, unless there is something particularly extraordinary in it, it doesn't usually gain widespread media attention. Reports can also be seen as dry and technical by the broader public, which limits their exposure.
4. Target Audience:
Press Release: The press release can be tailored for different audiences—retail investors, analysts, media, and the general public. This flexibility increases its chances of garnering attention from outside the investor community.
Quarterly Report: The quarterly report is primarily aimed at providing transparency and detailed financial information to investors, which means it's not necessarily written with the goal of attracting public attention outside the financial world.
Conclusion:
For an OTC-traded company, a press release is far more likely to garner broader exposure compared to information released only in its quarterly report. Quarterly reports are often more technical and geared toward investors, while press releases are specifically designed to attract immediate attention and reach a much wider audience.

I asked meta AI for more explanation on off-label use.

Here it is.

The 21st Century Cures Act doesn't explicitly state that off-label uses are approved, but it does facilitate the use of real-world evidence (RWE) to support the approval of new indications for already approved medical products ¹.

This means that once a product is approved, data from its real-world use can be used to expand its approved uses, making it easier for healthcare providers to use products for off-label purposes.

Additionally, the act promotes the use of adaptive trials, modeling, and simulations to evaluate a product's safety and effectiveness, which can also support off-label uses ¹.

While the 21st Century Cures Act doesn't directly approve off-label uses, it creates a more flexible and innovative regulatory environment that can facilitate the use of medical products for new purposes.

Seems pretty clear to me that DCVAX is caught up in the waiting game.

>>Looking ahead, the MHRA plans to expand the guidance so it applies to different types of highly personalised therapies, including for rare diseases.

https://www.europeanpharmaceuticalreview.com/news/246893/draft-regulatory-guidance-on-personalised-cancer-therapies-published/

MHRA are “collaborating” with the company on completing the maa

MHRA collaborates with EVERY company that submits an MAA, every MAA eventually reaches completion.

Unreal LOL

But it won’t come without any other news, because they likely have matters pending approval. Hello?

There is absolutely nothing about the technology transfer of direct to Sawston that is pending approval. Absolutely nothing.

There is absolutely nothing about the Roswell park expanded trials that is pending approval. Absolutely nothing.

ETA: Thought you were responding to the other thread. Point remains above, but to address this specifically - that's fine. You can believe it won't come without other news. I tend to think it won't come without other news, but I'm not really confident. That doesn't change the nature of what my prediction was. I said that without other news, MAA approval won't have the short term impact that people think it will. I said without other news, the single day price rise will be suppressed to under 100%. The entire price prediction thread is predicated on MAA being announced with no accompanying news. Not because that's what I think will happen, just because that is the most logical way to make the estimate. It'd be silly to try to guess what all news will accompany MHRA decision and to make predictions based on that scenario alone.

You're trying to argue with me saying my price prediction for day of approval news with no accompanying news is too low, while also saying you agree that if there isn't other news the approval will get knocked down.

I'm not saying there will or won't be other news. There should be, there is zero doubt they've got rounds in the chamber.

I'm saying they have no reason not to fire those rounds off now. Use them to stop the asinine dilution that has been occurring over the past years.

If they had released all that news like I said and the price was at a buck, approval could likely get them to $2.

If they announce approval at $0.25, then announce all that other news in rapid succession....we'll likely get to a similar price around $2.

It's the same end. So slow the dilution now. People thinking there is gonna some grand explosion of price because LP has sat on this news for so long and is releasing it all at once are gonna be really disappointed.

I hope I'm wrong and a news wave does make the stock run to $10 shortly after approval. If that happens, I'll post pictures for y'all of me standing in the middle of the busiest intersection of my city wearing only a speedo holding a sign that says "I'm sorry Linda Powers". But it ain't happening.

You are quoting from a post Mike later said he intentionally distorted as payback. Nice job hairbrain.

At least I'm willing to admit that I distorted your claims. You intentionally distort and blatantly lie about things I say and when called out on it, simply move on like it never happened.

MHRA are “collaborating” with the company on completing the maa.

If you have further questions take it up with them, basher.

My whole post was in regards to the dot connecting you did on an e-mail from MHRA.

Would you still be dot connecting these ridiculous pumps if you knew that the e-mail came from Corporate Communications? Do you really think they have detailed information on the application outside of what's in their database?

smh please continue you amuse us!

But it won’t come without any other news, imho, because they likely have matters pending approval. Hello?

Mike, you know about those things because they publicly provided them! The whole world has access to them. In your PR world, a well articulated PR will solve everything.

The whole world has access to any level of education they want. Anyone with computer access could (maybe not easily) teach themselves to be a nuclear physicist. Having access doesn't mean you are accessing those things. The company must do their part to put the information into the public domain.

Nobody reads the 10Q of an obscure prerevenue biotech stock trading OTC. I'd bet less than 25% of actual NWBO investors have read that Q in full and understood the implications.

It's the company's job to make that information easily disseminated and understood by the public, investors and more importantly those non-invested.

I'd be willing to bet less than 1000 people globally that aren't invested in NWBO have read that Q and know what it means.

Juxtapose that with the exposure a PR on globalnewswire would get that news, and it isn't even comparable.

Are you going to be happy if the next Q comes out in March and there is a footnote that says "by the way, we received notification from the MHRA that our MAA was approved on February 10th" and NWBO never issues a PR about it?

No, you're not, so stop using this argument that putting it in the Q is enough.

Best article in a while serving up some actual clues as to where DCVAX is in the mix.

>>MHRA said its proposed guidance only addresses mRNA cancer immunotherapies that use lipid nanoparticle delivery systems. More specifically, it is intended to cover cancer immunotherapies that contain mRNA as the active substance encapsulated in lipid nanoparticles that deliver the vaccine.

Regulators said they will update the guidance as they gain experience in other technologies, such as peptides, non-integrative DNA, and polymer delivery systems.

MHRA noted that cancer immunotherapies are often called cancer vaccines. However, based on definitions in the Human Medicines Regulations (HMRs), individualized mRNA cancer immunotherapies do not meet the definition of vaccines, so instead, the agency will refrain from using the term. The therapies in these cases are tailored to a patient's unique tumor neoantigen profile.


https://www.raps.org/news-and-articles/news-articles/2025/2/mhra-drafts-mrna-cancer-immunotherapy-guidance

You are quoting from a post Mike later said he intentionally distorted as payback. Nice job hairbrain.

Who are you trying to kid? If teamFUD can attack and spin lies on excellent TLD results into a twisted FUD narrative, for purposes of an orchestrated bear raid, you don't think they would spin an attack on such PRs? We know you know your team better than that. We see your spin for what it is. 👿☠️
I said if NWBO had released those 8 press releases I mentioned, the stock would likely be over a buck.