Northwest Biotherapeutics Inc (QB) (NWBO) News

Something we all should realize is that there is no cheap way of treating a really deadly cancer. Whether a cure is achieved, or not, millions may be spent, or at least billed, in the course of treating the patient. If a product is approved and is the only one that may be of benefit to a patient, insurance will be forced to pay. What they'll pay may very well be far less than the billing price, or the list price of the specific drug, but the patient will be treated.

If NWBO never discovered FlaskWorks, and no one else came along and suggested an automated way of making the vaccine, they still could have been very profitable. Their cost would be higher, they'd employ many more people, but the demand for the vaccine would have been just as great and they, or someone, would have built the tens of thousands of tiny cleanrooms needed to make it happen.

DNDN didn't fail for lack of the ability to make Provenge, they failed because it simply wasn't that superior to other therapies for a form of cancer that's often cured or well controlled. That's very different from GBM and perhaps other cancers, like Pancreatic, where anecdotally some success has been seen.

The pricing of DCVax-L will have far more to do with the cost of developing it than the cost of actually making it. Sure, manufacturing will be a consideration, but if most therapeutics were priced at a reasonable multiple of what they cost to make, with no consideration of what they cost to develop, we'd be paying a tiny fraction of what's actually being paid.

To my knowledge, treatment with DCVax-L and other therapeutics that may be utilized with it, will not require hospitalization, and I suspect can be administered in many oncologists offices, not requiring a hospital at all. Of course that's not true of the surgery required to obtain the tumor, but even there I'm uncertain if substantial time in the hospital will be required.

In my treatment for leukemia, I had several courses of chemo that required extensive time in the hospital. That hospital time very probably added far more to the cost than the therapeutics I was being treated with, though the list prices were substantial. I believe the insurance, Medicare, etc. did settle the bill for substantially less than the list price. On very few occasions my Drs. did have to speak with the insurance company to get therapeutics not tested for my disease, they always got what they wanted, and it was covered. In reality, all sorts of therapeutics are routinely used off label because they're known to do the job. BP's etc. don't try to run trials on everything their products can be effective for. They can't advertise the benefits, but Drs. everywhere learn what works from one another.

DCVax's will be seen to work, demand should be huge as long as it can be met, the revenue produced will be huge as well. We just need to get the EDEN approved and have good sources for manufacturing the units and disposable cassettes.

Gary

The prevailing assumption is if the DCVax platform is approved and can be manufactured/commercialized cost-effectively, the ROI is a given. I think that is a reasonable and likely assumption.

learningcurve2020,

Ten years ago was when the combo patent got the Street’s attention and Mr. Woodford chose to come on board. The shorts like Steven Giardino and others got burned by that move when followup funding took the price to $12.54 the following Spring. Best wishes.

alphapuppy,

I’ll take the time to correct my first post to you here as L does break down dead and dying cells but creates radiological issues from the immune response in and around the tumor bed. There are other cells that do a better job of removing large amounts of necrotic tissue which are not always fully engaged by L or Direct as originally trialed. So.. what NWBO is working towards is the more complete immune response that clears out tumor debris more quickly instead of leaving it in place as long as has been the case in the past that creates up to a three month wait to determine if progression or pseudoprogression is responsible. Best wishes.

sentiment_stocks,

Remember that Ken said the market makers should be the ones setting the price? I figured that the cycles being created in many stocks were indeed being controlled by big traders or market makers many years ago. Those cycles often are influenced by financing and other news cycles but sometimes corrections were happening too fast and obviously benefitting some entities over others which is why what Ken said explained many of those regular as well as strange situations. May 10th, 2022 was one of those obviously targeted times that I believe was something many market makers were planning for as a weakness created by FDA process and threats of lawsuits if that process was not followed ie a deliberately created weakness built into the system for reporting changes to endpoints that allowed for attacks. NWBO is being forced to prove collusive behavior by way of discovery even though spoofing was obviously in play that day. Best wishes.

Thanks, Doc. I just seem to recall that when you get an immune response, sometimes the tumors can actually radiographically appear larger because of all the immune cells congregating in the area of the tumor. It’s not a bad thing, but it might be kind of hard to judge size Radiographically. My worry is that we get into another trial that we can’t interpret very easily. if we just use size criteria. We have to carefully look at size maybe on sequential radiographs so that we count for those tumors that look like they have grown when in fact, they just have a good immune response.

Great post, I suggest the moderators sticky this post.

Gary

flipper44,

Could be, I just don’t remember anything claiming official count starting in March so I’m under the impression that backlog has something to do with the timing. Either way we are close as the average time was 237 days at last MHRA report. Best wishes.

Once again you are speaking out of your backside LC …

More basher fud…

U have zero idea how much specials revenue has occurred .. no one knows ..

You attempt to speak like you are an expert on the matter ..

You are definitely
No expert …

Just a spineless basher using multiple aliases … get ready for your orange jumpsuit …

LC,

The management were younger ten years ago? 😶

I can’t argue with that—I think you’re right. I’m sure glad you got to publish that revelation tonight before you reached your 30-post limit.

Your comments about 2012-2014 did remind me of Dr. Steinman, so I think you might actually have a good point about the “buzz” around that time ten years ago…

It is fascinating to hear that there were smart people who had such sharp foresight back then—I would bet that their enthusiasm was inspired by Dr. Steinman’s work and the Nobel Prize that was awarded for his “game-changing” discovery of the dendritic cell in 2011.

Today, in 2024…

Dr. Steinman’s Nobel Prize-winning work lives on at UCLA and Roswell Park! His work was the foundation for the DC technology that will impact the 🌎

At 32, Maui resident Jamil was diagnosed with #glioblastoma, a terminal brain cancer, and told he had about 17 months to live. Jamil beat the odds with a clinical trial using a novel cancer vaccine developed by neurosurgeon Linda Liau, MD, PhD. Read more: https://t.co/PB47EQGo9G— UCLA Jonsson Comprehensive Cancer Center (@UCLAHealthJCCC) August 22, 2024
Another Clear M.R.I With Dr. Cloughesy. NWBO DCVax-L The Future of Personalized Immunotherapy. @LisainNJUSA @apwriter @metacollectiveG @ElvirPons @LastWeekTonight @StackingAG @UCLA pic.twitter.com/04nKESEhHV— Thomas Owen McCaffrey (@ThomasOwenMcCa1) September 16, 2024




https://www.uclahealth.org/news/article/brain-cancer-discovery-clinical-trials

https://www.societyns.org/about/officers-detail/linda-m-liau-md-phd-mba-4



https://scitechdaily.com/supercharging-the-immune-system-uclas-pioneering-vaccine-shows-promise-against-deadly-brain-cancer/

https://www.prnewswire.com/news-releases/northwest-biotherapeutics-announces-that-dr-linda-liau-has-joined-the-companys-scientific-advisory-board-301924864.html

https://thejns.org/caselessons/downloadpdf/view/journals/j-neurosurg-case-lessons/8/2/article-CASE24112.pdf

https://www.nature.com/articles/s41467-024-48073-y

https://www.jci.org/articles/view/169314

https://jamanetwork.com/journals/jamaoncology/fullarticle/2798847

This month will mark thirteen years since the death of Dr. Ralph Steinman to whom the world owes an immeasurable debt of gratitude. Thankfully, brilliant physicians such as Dr. Linda Liau have built upon Steinman’s Nobel Prize-winning work to develop a novel platform technology that will impact the practice of medicine worldwide.

The recent development and evolution of dendritic cell technology has been vast, and Dr. Steinman’s prophetic comments foreshadowed DCVax-L. In the last 3 minutes of the YouTube video, Dr. Steinman describes the “first generation of this approach” which used only ONE antigen. Consider that DCVax-L can now present hundreds of distinct antigens!




https://www.mcgill.ca/newsroom/channels/news/dr-ralph-steinman%E2%80%99s-work-immune-system-%E2%80%A8celebrated-nobel-prize-committee-187060


https://www.britannica.com/biography/Ralph-M-Steinman







https://investorshub.advfn.com/boards/read_msg.aspx?message_id=175111374

⭐️ Combo is King! ⭐️

Nobody but "management" has a clue. Poor Joan thought they'd be pulling in a hundred million dollars two years ago with Specials. I'm sure there's a reason they don't want to share Special stats with the public that leads to their dismal recruiting.

>>How many patients have received DCVax-L through compassionate use program by now?

How many patients have received DCVax-L through compassionate use program by now? Definitely over one thousand. Has anyone in the review committee ever seen that hundreds of tumor-associated antigens can be presented to immune system by dendritic cells primed by NWBO's technology?

Do your homework and stop this type of nonsense.

BTW, AbbVie acquired ImmunoGen for $10.1b. You know about ImmunoGen? It is a company that has ADC program. Take a look which company sold its shares in this ADC company.

https://news.abbvie.com/2023-11-30-AbbVie-to-Acquire-ImmunoGen,-including-its-Flagship-Cancer-Therapy-ELAHERE-R-mirvetuximab-soravtansine-gynx-,-Expanding-Solid-Tumor-Portfolio
https://fintel.io/so/us/imgn/baker-bros-advisors-lp

Maybe, but I can tell there was a lot more buzz around NWBO 2012-2014 than now. Many were writing positively but now all you have is Smith. The FDA was still the regulator back then too. They were on the Nasdaq. Most thought Cognate would become part of the company. There was Switzerland. They had some cash with much less outstanding. And, management was younger doing conferences and interviews without all the future disappointments.

>>Prospective value is a forecast that should be based

It will either get approved or CRL with the advice of run a properly designed trial. And if it gets a CRL, You can guarantee the company and paid pumpers will try to spin it as a positive. But CRL means the kiss of death for this company.

There will be no conditional approval.

No matter how many times it's explained they just don't want to understand. The share price may end up at all time low but the market cap is much greater than before due to massive increase in shares outstanding.

That is just silly. Even conditional approval gets NWBO a revenue stream. It would not impact EDEN development or the increase in treatment utilization that comes with EDEN.

No way on God's green earth that NWBO "test all time lows...".

Nice try but no cigar.

I would like to see if Congress’s health plan would pay for a 2.1 million dollar treatment. I know my health care plan would not.

Foogie88-
Ok, Tomorrow is Sept 20 and still Nothing on the Approval , - Talk to MHRA

Nothing on the Lawsuit - Talk to the Judge.

Nothing on or about any Collaboration with other’s about a partnership or Licensing deal. NOTHIN- Talk to Merck

First of all, NICE doesn't matter in the near term after approval. There is more than enough money running around the world to keep NWBO and the manual process busy.

What you seem to overlook is that once DCVax-l is approved it has a world wide population to treat. Most of those people won't have enough money to afford the treatment out of pocket, however there are more than enough people with the money to be able to pay for the treatment themselves. Consider how many high end cars there are in the world. Those are people with enough disposable income that they can spend $100K+ on a car. If the choice comes between a fancy car and getting treated for a life ending disease, those people will find the money for treatment.

Then there are the folks that can raise the money one way or another. Just like we are seeing with the go fund me guy in the UK.

NWBO will have the time it takes to get NICE approval, which will not take nearly as long as you suggest.

Once EDEN is approved and there is much larger capacity having NICE approval will be important. Till then, not so much.

LC,

Ten years ago?? 😶



It would be illogical to suggest that the prospective value was greater BEFORE the P3, Flaskworks, JAMA, combo studies, etc. Where else should we look to access the value during the pre-commercial stage of a biotech company?? Should we have been following the minute-by-minute OTC price? I don’t think so.

Prospective value is a forecast that should be based on reliable evidence such as independently peer-reviewed medical literature, and prospective value can only be confirmed logically after the company transitions from clinical-stage status to commercial-stage status. Nobody expects price and value to align before a biotech has a commercial product unless the company were perhaps acquired before approval and commercialization.

Those of us who invested in advance of catalysts are not looking at the OTC price which is manipulated. We are looking at real indicators to assess the value of the DCVax-L cell-based platform, vast combo potential, Eden technology, and the patent-fortified IP portfolio owned by NWBO … all while the global cancer immunotherapy market is forecast to exceed 150 billion worldwide. A versatile combo-friendly platform could capture a substantial chunk of that market!

⭐️ Combo is King! ⭐️

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I have conviction in mine.

Surprised the disciples didn't think to do this for LP.

On YT:

"Jon Kahn - Fighter (Official Music Video)"

By better fit, here’s what I mean.

March 7 + 80 days + 60 days = July 25.

On August 2 there was an 8k stating inspections had already been scheduled, and the way it was written, “several days” could essentially account back to July 25. That doesn’t take much imagination to subtract a week.

As Senti pointed out, add another 70 days and you get October 3. Don’t like the week subtraction? Call it October 10.

Your very first "Fact" is not a fact. Seems to me the Street was much more interested in this stock ten years ago.

>>greatest prospective value that it has ever had since the company was founded.

Hmmm... interesting.

Dstock07, as I have been in since 2015 the metric I would like to see turn favorable to evaluate a CEO is return on investment.
Guess we all like to use different metrics

ooh my bad but its still accurate lol

NotSure2,

4 or 5?? Really? 😶

At first glance, I would put DCVax-L at a priority 2 maybe (high benefit, medium cost), especially for GBM.

There’s also a reasonable case to be made for DCVax-L to be categorized as priority 1 considering rGBM or even nGBM as an unmet medical need, and compared to the cost/benefit of currently available therapies. GBM treatment is already expensive, but it is paid for by the NHS.



You have to consider a lot of factors and every therapy has different existing SoC costs and different levels of efficacy.

AVXS-101 or Zolgensma was approved by MHRA (before FDA approved it), and it was approved based on single-arm data.




https://www.npr.org/sections/health-shots/2019/05/24/725404168/at-2-125-million-new-gene-therapy-is-the-most-expensive-drug-ever

https://www.nice.org.uk/news/articles/nice-approves-life-changing-gene-therapy-for-treating-spinal-muscular-atrophy

https://www.curesma.org/avexis-announces-single-arm-design-for-pivotal-study-of-avxs-101/
[/color]

Well that exactly is the problem with their communication strategy.

Right into my ear, and others.

Wow... that post of mine you responded to dates back to 2014. :)

Many folks questioning approval is actually a good thing for longs as we will likely get a much bigger pop.

I agree with you that conditional approval will not be beneficial to the longs in the short to mid term. This could result in a sell off and we could potentially test all time lows after the initial euphoria dies down.

And clueless minions have no chance to win.

And…….

Ok, Tomorrow is Sept 20 and still Nothing on the Approval , Nothing on the Lawsuit and Nothing on or about any Collaboration with other’s about a partnership or Licensing deal. NOTHING

Funding on GBM is available from DoD.

https://cdmrp.health.mil/funding/gbmrp

Yeah. Senti’s noise would have been a bombshell a month ago, but now it’s just a slightly closer fit. Regardless, we are in the window.

flipper44,

I don’t remember that either as either in guidance or NWBO stating that March date. I’m pretty sure we are within a 0-40 day space now of knowing MHRA’s decision based on the MIA update to Human designation and catching up on the backlog. Best wishes.

Once it became apparent the biologic development process would take longer, NWBO found a major financier and a lot of real estate in Sawston, plus a top regulator that allows compassionate care programs and was/is more adaptable to ECA. The UK is also a reasonable sized region for an initial launch.

more data available down the road a few months (aka further OS maturity and/or more data from compassionate and post approval, etc)

100%. NICE approval extremely unlikely in 2025, I would almost say impossible.
Maybe, a big maybe 2026.
2027-2028 more likely (if they are approve the first time they apply, or 2nd time)

This is black and white for anyone that did their homework on NICE/NHS.

They only get 3 chances, waiting for more data and automatic system should bring them higher in the "boston matrix" box where NWBO would fall. Right now due to high cost per patient they probably fall under priority 4 or 5.

Then they should have applied to FDA first because usually you can get higher price in US . They knowingly made that decision .

LC,

Thanks for reposting your opinion about the management again … I’ve enjoyed all of the enlightening insights you provided in your 25 posts or reposts today 😶

Fact ✅
Under LP’s leadership, NWBO today has the greatest prospective value that it has ever had since the company was founded. Today, they have a P3 completed with OS data, multiple relevant peer-reviews published, combo data, MIA awarded, MAA pending …etc., etc., etc.

Another monumental accomplishment of the management team was the strategic acquisition of Flaskworks! Manufacturing is becoming one of NWBO’s greatest strengths along with the novel cell-based product that they will be able to produce using their own technology! The invaluable automated manufacturing technology that Northwest Bio owns will become the key to global reach and global regulatory support. 🌎️

Price and value do not always align, which is the whole concept behind investing in advance of catalysts. The OTC is more volatile and attracts more manipulation too, but manipulation will be overpowered by the forthcoming catalysts.



The company is led by brilliant business professionals who are highly educated and experienced. They are circumspect in their statements, demonstrate strategic acuity by their actions, and each has a proven track record of success in their professional lives and in building wealth in general.

We do receive press releases when material developments unfold. Partial or premature updates are not necessary, and some news is made public through SEC filings or other disclosures.

You have the exemplary and talented management team to thank for many milestones that are solid components of the company. In my view, the most notable pre-commercial golden bricks that were carefully cemented into place include:

⭐️ Research Published in JAMA Oncology
⭐️ Research Published in Nature Communications
⭐️ Case Study Published in JNS
⭐️ Global Patent Portfolio
⭐️ IP Licensing Deals
⭐️ Multiple MHRA Approvals
⭐️ Additional Emerging Combo Data
⭐️ Manufacturing Technology Leading to BLA
⭐️ MAA Review

LP has been busy building a comprehensive worldwide patent portfolio, closing deals with institutions such as Roswell and SIO, and recruiting a renowned physician onto NWBO’s SAB whose work has been funded by NIH peer-reviewed grants for over 20 consecutive years—Dr. Liau joining the SAB at Northwest Biotherapeutics was awesome news!

Thanks in large part to LP, NWBO and the DCVax-L cell-based platform technology are associated with exemplary institutions and world-renowned clinical researchers. UCLA, King’s College, Brown University, and Roswell Park are some examples of well-funded institutions receiving peer-reviewed grants and gifts from smart philanthropists who believe in the innovative and visionary work happening within the walls of their laboratories and hospitals. Roswell Park and UCLA are truly world class research institutions on the cutting edge of emerging innovations in immunotherapy!

I would recommend seeking credible sources as opposed to reading inane postings on a message board. Consider consulting oncologists, reading the independently peer-reviewed medical literature, and researching the prospective value of recent deals and collaborations secured by the leadership team as more will be announced as we move forward.

⭐️Combo is King!⭐️

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If, by some miracle, NICE gives the nod the next thing you'll have to look forward to is wondering why the revenues aren't coming in even as LP still seems happy.

Good question. It makes no sense, and as a bonus, NWBO used esp to make it known which validation date started the clock. It does not match what the MHRA emailed to a poster (sparky?) here.

Edit: “I’m not stating that’s the reason, but it could be a factor. If NICE sets a low price first, then it becomes more difficult to justify a higher price later within the U.S. (FDA jurisdiction).”

Senti, unless NWBO ran into application issues, I doubt it would have taken 60+ days from submission to validate the application.

MHRA recently announced their average time to approval metrics, and it was around 237 days. 237 days from the January validation date was a few days ago. With Advent recently receiving their Human legal basis designation, I think we are much closer to potential approval than what we would be from a March validation stand-point.

Those 1 share trades may have been someone trying to prevent another from painting the PPS red at the end of the day. Seen it before.

Where did NWBO say that they believe March is correct validation date ?

... cornerstone of the Moonshot program :

Is this your personal opinion/hope or

are there any indication, statements, documents that support this view ?

Pls keep us peons updated. TIA

Well, if MHRA is trying to stick by the 150 day + 60 (=210) clock off time line, October 3 is 210 days following the March 7th second validation, which I've heard is the one NWBO believes counted as the validation date, not Jan 27, despite the letter Sparky received.

That said, I'm just waiting (trying to be patient) here like so many other longs. Fall starts in a few days, so hopefully, the MHRA MAA answer will come sometime during the Autumn equinox. :)