Northwest Biotherapeutics Inc (QB) (NWBO) Quote

Some may say LP should be telling us about her strategy, perhaps I have it all wrong, but I've observed many companies and seen only CVM ever discuss such things. I see what CVM does as hype, I had invested in them decades ago and they're still trying the very same drug in a totally different disease, when I invested they were after AIDS. I view the company as having the cure that's in search of its disease.

What??? Please go check other cell therapy companies and here are some examples
Commercialization Goal #1: onboard 30 ATCs at the time of the launch.
Commercialization Goal #2: onboard 50 ATC within 90 days of launch.
Commercialization Goal #3: onboard 70 ATC by 120 days of launch.
Commercialization Goal 5: 2000 patients per year, 12 core suites, 4 clinical suites
Commercialization Goal 6: 5000 patients year, 24 core suites, 4 clinical suites
Commercialization Goal 7: 10,000 patients per year, Site Expasion + Automation
Regulatory Goal 4: Submit to EU by 1H2024.
Regulatory Goal 5: Submit to UK and Canada By 2H2024.
Clinical Goal 1: Initiate the trial in Endometrial 3L by 2Q2024
Clinical Goal 2: Readout NSCLC by 2025

This is not out of the norm, but you cite a garbage CVM company as the only one that lays out their plans. I should expect nothing less out of you. This company doesn't have a cure to anything so please drop that ridiculous optimism. Is your job to defend what NWBO does as normal? Because it isn't working. Putting out goals and milestones is normal thing that companies do, and it is usually at the end of your Corporate Deck. But i forgot NWBO doesn't update their website or even have a corporate deck.....SMFH. This is such a garbage company. This is what accountable companies do...they guide to what their plans are. Something that NWBO fails miserably at. Sorry, your argument is a joke.

It would also be preferred if the shorts limited their posts to one sentence.

If you had a date certain for EDEN approval you could probably estimate when the BLA would be submitted, but that isn't possible. As for the FDA's involvement, all the regulators involved in the trial remain involved with the vaccine. The UK has the facility where sufficient manual production is available to approve it there, but no effort is being made to expand manual production. That's a choice the company made once they acquired the FlaskWorks company. I can't say if they realized how long it would take to gain EDEN approval back then, but I would think they had some idea, and perhaps it's taking longer than they originally thought. Even if they knew how long it would take, I very much doubt if they'd have built hundreds of tiny cleanrooms to qualify for US and other approvals.

Some may say LP should be telling us about her strategy, perhaps I have it all wrong, but I've observed many companies and seen only CVM ever discuss such things. I see what CVM does as hype, I had invested in them decades ago and they're still trying the very same drug in a totally different disease, when I invested they were after AIDS. I view the company as having the cure that's in search of its disease.

Gary

NoGro, you know the entire PFS issue with NWBO is old news as the OS data is the gold standard and the PFS is just a statistical estimation. Furthermore, NWBO summitted their application as of late December 2023. If you bother to calculate the true business days not weekend dates,
the timeline from January 1st to present day 9/25/24 is 183 days. According to multiple posts, the MHRA started their application process after 1/1/2024.
https://www.timeanddate.com/date/workdays.html?d1=01&m1=01&y1=2024&d2=25&m2=09&y2=2024&ti=on&

Per NWBO public release,
"The MAA seeks approval for commercialization of DCVax-L for both newly diagnosed and recurrent glioblastoma (GBM). The application also requests to be considered under the MHRA's rapid 150-day review pathway, which the agency has established for new medicines for serious unmet medical needs."
https://finance.yahoo.com/news/northwest-biotherapeutics-announces-marketing-authorization-143000107.html

Your BS once again falls short per your comments " They knew the trial failed using PFS primary endpoint so they totally redesigned it to give them a hope of success. Knew that the FDA wouldn't buy the B.S. as it violated multiple FDA Guidance guidelines so went to UK., and "Clearly UK isn't giving them favorable review process as that takes only 150 days and here they are just about a year and NOTHING."

Perhaps math was not your strong point as 183 days minus the true timeline that the MHRA started their work is not fare from 150 days, IMPO. Your excessive BS fails time and time again, time to move on, IMPO.

Well done Sky well done!

It's difficult keeping up with all the FUD posts... so would you and your colleagues (LC, ex, theory, robot, mani and the others) mind if you just tag your own posts with FUDster labels 👿☠️. It would be a big help to the board. Thanks!

Hey dimwit. All will happen in due time after the most important event happens soon... approval... including partnerships (which you failed to mention). SMH

Can’t answer my question? That’s a shocker.

The FDA especially abhor what they consider hype.

What the hell does the FDA have to do with it? They haven’t submitted to the FDA. They haven’t even said they’re going to submit to the FDA.

Saying they are going to submit a BLA isn’t hype, it’s strategy. Why does Linda Powerless refuse to say what their strategy is for submitting their flagship product to the world’s largest RA?

She doesn’t have to hype anything. Just say “we have a team of consultants working on the BLA and we hope to submit in 202x”.

How fucking hard is that?

FUD deflection as always from you, FUDster. Pay attention to what's most important.

You question humanity, and revenue.

I do not.

We disagree here

Here is one critical question for you:

What made Timothy Cloughesy found a comapny developing small molecule drug that can inhibit EGFR? How could he know that inhibiting EGFR is going to work?

So now you see from one perspective why I keep saying DCVax-L will be a platform for the development of precision medicine and why I claim that all these BPs which have precision medicine programs will have franchisement deals with NWBO.

I know you would love that

I just call it like I see it.

I hope it goes to $5 on approval.

But approval is practically priced in. Market wants more.

I’m not guaranteeing anything. I don’t know what it’s gonna do. But I’d bet a hefty amount that $0.50’s is the max if approval were announced tomorrow, and a red day isn’t off the table.

Northwest execs need to do more.

I'd agree with you, all those things are at least available for her to influence. I suspect that they're all being influenced by one, or two key events.

I don't believe that any new trial will be started until the EDEN can be used to make the vaccine. I think it could be permitted before full approval of the EDEN has been achieved, but I still believe the regulators would have to agree to it.

I believe the UK approval may be the second issue that may prevent further action as both the possibility of partners in new trials greatly increased, and far less dilution will be required if NWBO is fully, or partially funding the new trials.

Again, I believe the company is planning for everything that is to come. LP plays her cards very close to her vest, when the time is right, in her opinion, portions of her plans will be revealed.

Gary

Sounding like Droidobot

Mhra approval (if it ever happens) won’t help the stock to close above $1 either

You should also give up posting on penny stock boards at that point knowing the stock is going nowhere

This entirely discounts the media response

Temodar was approved 17 years ago as SOC for GBM for adding just two months to survival. Let that sink in.

Mike, really? A stretch, even for you.

Agree that complementary news will help, but .5?

Not a chance, if that is the case, I give up on humanity

Oncovir was seeking a partner to shape the future of biotechnology. There are over 141 clinical trials on poly-iclc over the past twenty years and I don't recall FDA approval was granted before. Its original patent will expire on October 1 in the US. Every potential partner would mention about this fact. I was wondering how Oncovir would not scare away any potential partners. There are two sets of data that can make the company attractive. One is from the combo trial in which Oncovir is one of the collaborators. The other is from the trial on HIV vaccine trial run by Linkinvax which is one of Oncovir's partners. I suspect Oncovir must have consent from other parties in the two trials before looking for a business partner.

https://www.vcpost.com/articles/126732/20240521/partner-with-biotechnologys-oncovir-to-build-a-healthier-future-for-all.htm

Biotechnology is at the forefront of scientific innovation and holds immense promise for addressing some of the most pressing challenges in healthcare and beyond. With breakthrough therapies and innovative precision medicines, the potential for biotechnology innovations in treating diseases or medical conditions is greater than ever. As the industry continues to evolve and expand, it is an exciting time to be a partner in shaping the future of biotechnology.

One such company worth exploring is Oncovir, the innovator of Hiltonol®. Oncovir President and COO Matthew Vandermast shares, "We promote Hiltonol® as an experimental viral mimic and broad activator of innate and adaptive immunity." While they have formed key financial and strategic partnerships, they are on the lookout for additional partners to help expedite R&D, clinical trials, regulatory approval, and, ultimately, commercialization of their potentially life-saving solution.
What Is Hiltonol?

It is a transformative immuno-oncology and anti-viral drug product and vaccine adjuvant designed to convert 'cold tumors' into 'hot tumors.' It mobilizes the body's immune system to combat cancer cells effectively. Because of its ability to address immune evasion in cancer therapy, it is a crucial step forward for improving treatment outcomes, reducing cancer recurrence and advancing the field of precision medicine for cancer patients.
Oncovir's Financial and Strategic Partnerships

With Hiltinol's vast potential, Oncovir has solidified a number of strategic and financial partnerships, and continues to be on the lookout for more. Vandermast notes, "We have partnered extensively with both commercial companies and academic institutions." The company has signed five supply and license agreements with partners who are currently in development of cancer or infectious disease vaccines.

"One of our key partnerships is with a company in Brazil called Eurofarma. They hold a license for our product, and they are also manufacturing it for us." Vandermast explains. The partnership with Europharma is significant for a number of reasons. They are helping to expand Oncovir globally, in Brazil and beyond. Likewise, the partnership facilitates faster market entry and regulatory compliance and is helping to accelerate commercialization.

Working Together to Solve Oncology Challenges

Oncovir's other partnerships, while confidential, are also essential to the team's commercialization and continued scientific research. "We have them in different regulatory areas in the world, some of them are in Europe, some of them are in the United States."

One of Oncovir's priorities is partnering with companies that are combining their own products with Hiltonol with the aim of addressing critical oncology challenges for patients. Currently, many of their partners' efforts are focused on conducting trials to demonstrate its efficacy and safety.

While their partners are supporting Oncovir financially, the team is also looking for additional partners who are inspired by their work and driven to help them propel the development cycle and get this life-saving product into as many hands as possible.

It's an exciting and profitable time to consider partnering with innovative biotechnology companies. As the industry continues to accelerate with its breakthrough therapies and novel treatments, the potential to create a healthier future for all is at our fingertips. With Oncovir's potential to address unmet medical needs, improve patient outcomes, and potentially revolutionize cancer therapy on a global scale, there is no better or more profitable time to become their partner.

Explore Oncovir today. Become a part of a healthier tomorrow for all.

https://vaccinenation.org/technology/linkinvax-welcomes-hiv-candidate-phase-i-results/

https://clinicaltrials.gov/study/NCT04201873

SWING TRADE (NASDAQ: SVRE) est. 13m float, at $0.15/share, oversold RSI 32, strategic partnership with Volvo. Full analysis here >>> https://broadstreetalerts.com/wp-content/uploads/2024/09/BSA-SVRE-SWING-ALERT.pdf

When one of a HF's computers sells to another, it's only taking from one pocket and placing them into another.
The apparent "dump" is all smoke and mirrors.

If you look at LP's biography, her various positions certainly don't suggest that she's a wallflower. I would suggest that it has far more to do with who the company is dealing with, the regulators. The FDA especially abhor what they consider hype. The CEO of a company with no approvals for it's products discussing them as the new paradigm in the treatment of cancer would almost certainly be deemed as hype. With UK approval, and more known about what's been done in compassionate use in the UK, I believe she'll be far better position to discuss what they're doing.

Companies trading on the OTC for pennies don't get invited to brokers or Institutional conferences, especially when they have nothing approved to market.

I believe with UK approval we'll get some attention, I think the share price will be up enough for LP to be invited to at least some of the smaller brokerage conferences and certain Institutions will welcome her. She won't be a wallflower any more.

Is the development of Eden within her power?

Are combo trials within her power?

Is the development of direct within her power?

Is the submission of a BLA within her power?

I’ll hang up and listen, thanks.

Such nonsense! You should know that MHRA approval and MTD denial are not in LP's power.
I know, it's a job.

Bro,
You are the one who has no clue what you are doing. Still hold your 10k by now? Have you loaded more?

This is the most vetted stock on this planet. At this stage, we don't need LP to tell us explicitly the path forward. She can certainly tell us after the approval. The path forward is not vague. NWBO's technology can treat most diseases treatable by immunotherapy. Moreover, the technology will be the fundamental platform for drug and vaccine development. Why all of sudden precision medicine becomes such a hot subject? You would agree Dr. Vivek Subbiah knows a lot better about precision medicine. So don't worry about the path forward.

We just savor the fact that the company made the biggest through in medicine and we can load a lot more if possible. I didn't use the word 'biggest' before, did I? If Dr. Liau can reach definitive conclusion by just recruiting just one third of the patients originally planned, I think I can draw definitive investment conclusion too.

Droid,

No, it will probably look something like these other press releases that actually were not delivered by pig…


June 2024

https://www.prnewswire.com/news-releases/northwest-biotherapeutics-announces-exclusive-in-license-of-portfolio-of-dendritic-cell-technology-and-intellectual-property-302174237.html

February 2024

https://www.prnewswire.com/news-releases/northwest-biotherapeutics-moves-from-optimization-of-flaskworks-prototype-to-fabrication-of-gmp-compliant-units-for-installation-validation-and-final-testing-prior-to-regulatory-certification-302054769.html

December 2023

https://www.prnewswire.com/news-releases/northwest-biotherapeutics-announces-that-a-marketing-authorization-application-has-been-submitted-to-the-uk-mhra-for-dcvax-l-for-glioblastoma-302021038.html

September 2023

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

March 2023

https://www.prnewswire.com/news-releases/northwest-biotherapeutics-and-advent-bioservices-announce-receipt-of-license-for-commercial-manufacturing-at-sawston-uk-facility-301776725.html

December 2022

https://www.prnewswire.com/news-releases/northwest-biotherapeutics-announces-mhra-approval-of-license-for-gmp-manufacturing-at-sawston-uk-facility-301449083.html

August 2022

https://www.prnewswire.com/news-releases/northwest-biotherapeutics-announces-approval-of-pediatric-investigation-plan-pip-by-mhra-301610850.html

July 2022

https://www.prnewswire.com/news-releases/northwest-biotherapeutics-announces-filing-of-application-for-license-for-commercial-manufacturing-at-sawston-uk-facility-301581737.html

February 2022

https://www.prnewswire.com/news-releases/northwest-biotherapeutics-announces-commencement-of-cancer-vaccine-production-at-its-sawston-uk-facility-301484857.html

September 2020

https://www.prnewswire.com/news-releases/northwest-biotherapeutics-acquires-flaskworks-301122058.html

Today, NWBO is on the cusp of initial regulatory approval and the beginning of their commercial-stage status as a company.

Fact ✅: The management are advancing the company toward commercialization every day, and they do provide material updates when appropriate.

The scientific innovation of the novel DCVax-L platform technology is the core foundation of the company’s prospective value, and DCVax-L has been independently peer-reviewed and is currently being reviewed by the MHRA right now. The worldwide IP patent portfolio, DCVax Direct, manufacturing technology, and potential for additional broad range of application of DCVax-L in combination with other technologies for other cancers adds even more to the expansive value potential going forward.

NWBO is advancing each day in all four key areas. Some keys are interconnected too—Oncovir and Roswell could become relevant to more than one of the keys (to name two examples).

Key Determinative Factors:
🔑 Approval(s)
🔑 Manufacturing Capacity Leading to BLA
🔑 Partnerships
🔑 Ongoing/Expanding Combo Studies

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



https://physicianresources.roswellpark.org/news/roswell-park-clinical-trials-offer-novel-immunotherapies-for-advanced/metastatic-tumors-refractory-melanoma






“The license includes 5 new patent families that were just filed in 2023 and hence have their full potential patent life ahead of them. The technologies include enhanced versions of dendritic cells (DCs) and DC based therapies, as well as conditioning regimens designed to enhance patient responses and approaches to reprogram the tumour microenvironment to boost immune therapies and help overcome resistance to checkpoint inhibitors.

The DC based therapies include versions with tumour antigens loaded into the DCs and versions for intra-tumoural administration without pre-loading of antigens. Phase 2 trials involving the licensed technologies for two different cancers opened for enrollment earlier this year and are currently under way, and a third phase 2 trial for a third cancer is pending. The trials are fully funded by grant funding and are being conducted as investigator led trials. The company does not anticipate having to provide any funding or undertake any operational role for these trials.

As previously reported, over time the company has been quietly in-licensing various technologies and IP from various institutions and entities which it believes can be valuable in building a leading franchise in dendritic cell therapies.

The portfolio in-licensed from Roswell Park is complementary to, and builds upon, a portfolio which the company exclusively licensed from another institution last year. Together, the two portfolios encompass more than 20 years of work by one of the foremost groups of dendritic cell experts, led by Dr. Kalinski.

The portfolio in-licensed last year includes the foundational technologies and IP, and positive early-stage clinical trial results, developed by the Kalinski group over 17 years before coming to Roswell. The portfolio in-licensed now includes the further work during the last 7 years at Roswell. Taken together, the company believes that the two portfolios comprise a whole that is greater than the sum of its parts and offer compelling synergies with the company’s own portfolio. The company plans to collaborate with Dr. Kalinski on the further clinical development of the combined technologies.”

https://brownneurosurgery.com/breakthrough-brain-cancer-vaccine/






https://www.kch.nhs.uk/wp-content/uploads/2024/09/Roadmap-to-developing-and-delivering-world-class-research-6.pdf




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.siocapital.com/

https://www.garykmichelson.org/blog/gary-michelson-announces-historic-gift-to-ucla

So to be clear, you’re counting on Northwest Bio, whose CEO is petrified of social situations, who has only made two public appearances in the past 4 years, to have an excellent media campaign to support the stock price? When has NWBO ever, EVER, shown that they are capable of handling public relations?

The approval PR will say that MHRA approved, and it will talk about how much work was done to get it approved. It won’t talk about a path forward. Because NWBO only ever talks about the past, and what they’ve done; never about the future, and what they will do.

Because Linda Powerless has no clue what she is doing.

I don't believe you're right, but much will depend on how the release is done, and how it is received. Does the release suggest how unique the vaccine is, how it should be considered a new paradigm in the treatment of cancer.

Of course I'm not speaking of the words in the company PR, they would be considered hyping the vaccine if they said it, but it's how the media reports on what the vaccine represents.

If the media totally fails to pick up the news on the UK approval, the reaction to it may not be that great at first, but it will build over time. On the other hand if we get a great deal of media attention, no telling how high we may go.

Gary

OMG another good omen?

The ihub add at the bottom of my post is the Rich Guy piece of the Monopoly game!

I’d go outside and see if I get crapped on by a bird for further luck, but it’s already dark and only bats are flying. I don’t think guano is lucky except for plants and bugs

If approval news come at 33 cents, I am not sure what price NWBO will be traded afterward.

I’d be shocked if it closed over $0.50 day of. Need other news. Don’t think anyone cares about MHRA approval anymore.

Hi Folks,

I opened a single fortune cookie tonight and it read:

You will receive important news Thursday!!!

Today is Wednesday so I won’t have long to wait!

Koinkidink? Approval news?

And what about Naomi? (Real old reference that boomers might remember)

But seriously, do you think our management is going to send the powers to be a PR the day before they want it to be released?

Releasing a big PR tomorrow.

Lemme just go ahead and send it to the random desk jockeys at all the news wires at 3:45 the day before, prior to the market closing. That’s standard procedure right? What could go wrong?

You're right, in the past year we've really not had great news, even once. The good news has been few, and far between. That's in the past year.

I believe the chances of great news in the next year are great. I suspect that we'll get UK approval, EDEN approval, and at least submissions to the FDA and others. I think most here would agree that if these things occur it should be a really great year.

Gary

I hope approval PR out when NWBO trades at 80-90 cents. Approval would send it to $2s over night. If approval news come at 33 cents, I am not sure what price NWBO will be traded afterward.

Would not be surprised to see a PR at 9:31 tomorrow.

Think you’d be the only person on earth that wouldn’t be surprised to see an NWBO PR.

A pr, from nwbo? HAHAHA, I guess it will be delivered by a flying pig fro a froze over Hell.

I remember that there were two levels to this. I think, years ago, some thugs from Hungary or Ukraine were hacking PRs to news agencies. Clearly illegal.

I also think some people get pinged (from whom I don’t know) a PR was sent for release after some company sends it to news agencies for next morning release (after the bell), but no idea if this is true or if it’s legal.

Anyway, on stuff like this, I just don’t know at all.

PS: attilathehunt, I didn't mean to put down your idea about a pending PR. Thanks for the suggestion and I love it! Maybe you're right, because I don't know how these thing are done with PRs. Sharing ideas helps us all get to the bottom of these issues.

OK, attilathehunt, I'll be sitting here with my computer waiting to see that amazing PR at 9:31 a.m.
But seriously, do you think our management is going to send the powers to be a PR the day before they want it to be released? It would be easier for me to believe in a leak, even though management has done a good job keeping secret their business dealings. It's also easieer for me to believe Flipper's suggestion that MMs are basically creating fake buys and sells, just I can't see why.


Usually trades like that (up or down) may signal a PR was sent to the service that releases them...
Would not be surprised to see a PR at 9:31 tomorrow.

Yes, I've waited hour to buy a 1,000 shares at ask ora smidge over ask. Makes you wonder.

“Idk” “just a guess” 😶 Seriously, LC??


Your posts are baseless defamatory rumors.

So, now you want us to believe that they like to screw their relatives with worthless gifts?? Or did you mean that they’re involved in some kind of securities fraud conspiracy? 🙄



https://investorshub.advfn.com/boards/read_msg.aspx?message_id=175134306

I beg to differ

Once you have a crossover you de facto are treating rGBM because of the progression being new growth of tumor imo.

The mods would have you all believe that this DC (Washington) crew have no government contacts.

I don’t know, I just wonder how someone got the market makers to respond so quickly to them. That’s what really caught my eye. When I buy, it’s like molasses. Today was like molasses, then boom, on seemingly no news, boom, the market maker moves like ⚡️.

You're right, Flipper. All executed in the same second. 15:49:34. With NWBO, sometimes it takes many seconds or minutes between trades, so those 5 trades of 75,000 shares each (375,000 total) in a second are quite unusual. Maybe you're right that someone's bouncing trades back and forth. But then, what's the point? Why bump up the number of trades made in a day?

Trades today in NWBO:
15:49:34 0.335 75,000 Sell 0.335 0.3378 2,158,482 309 nasd
15:49:34 0.335 75,000 Sell 0.335 0.3378 2,083,482 308 nasd
15:49:34 0.335 75,000 Sell 0.335 0.3378 2,008,482 307 nasd
15:49:34 0.335 75,000 Sell 0.335 0.3378 1,933,482 306 nasd
15:49:34 0.335 75,000 Sell 0.335 0.3378 1,858,482 305 nasd

Idk, maybe on top of all those millions they gift relatives for a few hundred thousand while maintaining control?? Just a guess.

https://www.kch.nhs.uk/wp-content/uploads/2024/09/Roadmap-to-developing-and-delivering-world-class-research-6.pdf