Northwest Biotherapeutics Inc (QB) (NWBO) Quote

As I said, the court case is DOA, as are most things in nwbo land.

At the end of time after Linda Grifter decides she has stolen enough cash.

You are quite right, Guzzi; he should have heard of DCVaxI and he should be able to fund the treatment.

If he is sceptical all he has to do is read the scientific papers that have come out of UCLA and NWBO which, with his scientific mind, should assuage his scepticism. If he remains a sceptic he will go to his death a sceptic whereas having the treatment will show him how wrong he was to be sceptical.

You are so full of it.

I'm sure that they would love to treat the Professor in one of their trials - but if it were you (and you were being honest with yourself), would you opt for a punt that this early stage treatment which has not yet produced any real world results beyond demonstrating that it increases T-Cell infiltration of the tumour, or would you choose DCVax-L which is currently showing >50% success rate with its combinations and which is already available for use?

He seems to be a pathological liar, just like LP, LG, and DI.

Understaffed, are you kidding me? The reason why they took over 3 years to submit MAA and double/triple check the application before submitting to the UK was so that they could apply to multiple RAs. They simply lied to investors at that point.

When your existence and ability to turn profit depends on US approval, you do whatever it takes to submit an application and not come up with excuses. This is why no credible institutions would back them.

They won’t be able to hide anymore. The lies and dangling of carrots catches up soon.

They are likely to get sued in Q4 this year. A few shareholders that care about ROI and opportunity cost are going to come together and expose the lies. Thats all I will say.

What he is saying is that DCVAX wont get approved by the FDA if that promising pathway act is not passed. It’s not about Flaskworks and volume manufacturing as some liars and pumpers here claim!

As I said, LP and the team are likely to get sued later this year. The lies and dangling of carrots catches up at around the 5 year anniversary of data lock.

Surely the good Professor Richard Scolyer have heard of DC-Vax?

He should be able to raise money, a prominent person like that, for a vaccine in the UK?

Maybe he is sceptical about the vaccine?

But he don't have anything to lose, so?

#dcvax $nwbo #gbm pic.twitter.com/rnxVOVYHeO— Peter Davis (@peter_brit) March 11, 2025

Wiz888999
@ODB123
🔥🚨 DTCC is officially in the HOT SEAT! 🚨🔥

Court orders them to hand over records on daily failures to deliver, clearing data, and all that behind-the-scenes broker magic.

The receipts are coming out, and someone’s about to get BUSTED. 🍿👀

This ain’t just a nothingburger it’s a full-course meal. Who’s hungry? 😏

🔥🚨 DTCC is officially in the HOT SEAT! 🚨🔥

Court orders them to hand over records on daily failures to deliver, clearing data, and all that behind-the-scenes broker magic.

The receipts are coming out, and someone’s about to get BUSTED. 🍿👀

This ain’t just a nothingburger… https://t.co/Pg5TEsPpRX— Wiz888999 (@ODB123) March 11, 2025

Thanks, Doc.

I would hope and expect that by now any neurosurgeon worth his salt would know that material for possible use in the manufacture of DVax-L has specific storage criteria.

I just find the whole thing sad; an eminent man apparently turning his back on a non-noxious treatment that might save his life and the only thing that might cause him any discomfort is a leukapheresis and a minimum of 3 intradermal injections in his arm.

Gary, I believe, I suspect, I assume that the company will get aproval by next week...

March-June 2024.... It goes on forever...

This is less than 5% of his wrong "believe" or predictions...

https://investorshub.advfn.com/boards/read_msg.aspx?message_id=174102970

https://investorshub.advfn.com/boards/read_msg.aspx?message_id=174191335

https://investorshub.advfn.com/boards/read_msg.aspx?message_id=174191473

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https://investorshub.advfn.com/boards/read_msg.aspx?message_id=174434425

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Just non stop wrong, over and over and over again...
Doesnt beat Dstock, but almost does due to the high amount of them.

DocLee,

That's the point of my post. It strikes me that some of the them knew about DCVax-L. Did you see how many papers Georgina V. Long coauthored with Antoni Ribas who is Dr. Liau's colleague? Did they suggest DCVax-L to Dr. Scolyer? Is David Reardon among the coauthors? Can you believe he and Antonio Chiocca wrote a critical article tantamount to a hitting piece published on the Thanksgiving?
https://academic.oup.com/neuro-oncology/article/26/2/211/7444576

According to the post from DD, there are over 62 long term survivors. And the analysis done by NCI researchers along with Dr. Liau clearly shows that for the most life-threatening subtype of GBM, DCVax-L has the most significant efficacy. Here we are talking about DCVax-L alone case.

The current combo trial is still enrolling patients and it only needs at minimum 2 gram tumor tissue. I see no reason why he cannot give it a try.

Here is the first 32 minutes of the Webinar, WITHOUT the much talked about Q&A, which had explosive information.

The Q&A is summed up on the image below.https://t.co/z7cB2JMaNS pic.twitter.com/5dnOq8YYRP— 🇩🇰 The Danish Dude 🇩🇰 (@FlemmingBruce) March 10, 2025

If you're correct about every question being answered, it could be any day. I wish I were completely sure that you're right.

I would suspect that if any questions are still being answered, they may very well be answered by contractors which NWBO doesn't have full control of, perhaps even from Doctors or others involved with the clinical trial, or perhaps even with compassionate use.

Gary

Where would we be if all 4 regulators approved DCVax-L, but without approval of the EDEN, we could provide roughly 1000 batches of vaccine to 300,000+ new patients who're newly diagnosed worldwide each year.

The key, since we acquired it in 2020, is getting the EDEN working in such a way that it meets the regulators demand. I frankly have no idea how long it took the scientists at FlaskWorks to reach the point that they could consistently make DCVax-L, I believe that's done. Now they must prove it.

I think the EDEN is a very different device today than it was when FlaskWorks was acquired. Only recently as I understand it, the company finalized exactly how the unit would be made and packaged. I cannot say if one or more companies are prepared to mass produce the EDEN unit, but I've got to believe the company is working on it, if they don't have the capability already. I frankly don't know the capability at FlaskWorks themselves, can they make the EDEN unit there themselves, or does it require contractors, others may know, I don't. I don't believe that have mass production capability, but I don't know that's a fact.

It's my belief that in time FlaskWorks will become its own profit center. I think it will be monitoring every EDEN unit that's in service, and will be responsible for their maintenance and any upgrades deemed to be necessary. In addition, I'd not be surprised if they create other similar units for making other personalized units for making products for other companies whose products don't compete with NWBO. They would perform the same services for these other companies and as I said, become a substantial profit center for the company.

I'm not speaking of now, but perhaps a decade from now we may all be surprised by how much the FlaskWorks division is bringing in.

Gary

Yes

He did not say DCVax-L was approved.

Doclee,

Phenotype testing should be done as well because if his GBM has a mesenchymal signature now, like many convert to at recurrence, L plus Poly ICLC have a much better chance to work. Then again, everything would still hinge on whether or not the resected material was properly stored too. Best wishes.

HappyLibrarian,

Funny how quickly it corrected once noted and shared with another about; ). Best wishes.

If approval denied what then, is it the end of NWBO and my money.

Data lock was over 4.5 years ago but the trial was over 8 years ago. This is the world record.....this is what happens when ceco priorities are building out her own CDMO(s) x 2.

You know you made it when you have an AI troll responding to your every post. Gotta keep truth from coming out by drowning you out.

No, but there is a time capsule Saturday event coming soon.

Woah ..... NWBO still ISN'T approved?  I'm shocked!!

Any regulator questions should have been adressed by now. Any guess on how much longer till approval?

Great. Let them focus on their branch of research, and not chime in in areas, they have no expertise in.

I'll repeat again that you cannot apply until you have a commercial production facility that will be ready for inspection by the regulator. The company doesn't have any such facility until such time as the EDEN can be used to make the vaccine.

20 tiny cleanrooms in Sawston don't constitute such a facility, they're adequate to get the UK started, but not the US or other more populous places.

If I'm right about 20 cleanrooms, each one is capable of making roughly 50 batches a year. That's 1000 total patients that could be treated in one year. Currently according to Google there are over 300,000 new cases of GBM annually worldwide, 1000 is less than the rounding error. It may be enough to get the UK started, but demand should require the EDEN there very shortly as well.

Once we've learned when approval of the EDEN is anticipated we'll know when filing with other regulators might be anticipated.

I'm not saying EDEN approval must occur prior to filing. I'm saying that it must be approved by a few months into the process when inspector can check the commercial production facilities. Clearly the company would need to be practically certain of EDEN approval before filing with one or more regulator.

Gary

Ego comes to mind.

zero82,

Thanks for reposting that again 😶

Yes, “relentless execution” …



✅️ She executed her plan to acquire, develop, and secure a valuable patent-fortified manufacturing technology called EDEN. (Flaskworks strategic acquisition was relatively recent in 2020).

✅️ She executed her plan to get a prestigious and reputable medical journal to publish an independently peer-reviewed analysis of the P3.

✅️ She executed her plan to acquire the commercial rights to ANOTHER patent-fortified novel dendritic cell technology that’s in PII trials funded by the U.S. DoD at Roswell Park.

✅️ She executed her plan to recruit Linda Liau to join the SAB at NWBO.

✅️ She executed her plan to secure a PIP approval and an MIA approval from MHRA followed by a voluminous MAA submission.

✅️ She executed her plan to recruit Dr. Ashkan to run the DCVax-L trial in Europe and lead the UK Specials Program that has the ongoing support of the MHRA.




“His work on brain cancer vaccines received the top presentation award by the British Neuro-Oncology Society in 2022 and promises to impact the care of patients with brain tumours worldwide.”
Consultant Neurosurgeon at @KingsCollegeNHS, Professor Keyoumars Ashkan, receives an MBE for services to neurosurgery.
 
In 2020, he removed patient Dagmar's brain tumour while she played her violin throughout the surgery. 👇pic.twitter.com/H2Z4LZic0h— NHS London (@NHSEnglandLDN) December 31, 2024
https://thejns.org/caselessons/view/journals/j-neurosurg-case-lessons/8/2/article-CASE24112.xml

https://www.kcl.ac.uk/news/professor-keyoumars-ashkan-awarded-mbe-in-kings-new-years-honours

https://www.bbc.com/news/uk-england-london-66378288

https://investorshub.advfn.com/boards/read_msg.aspx?message_id=175903429

A company that was serious would have also submitted to another regulatory agency such as FDA and EU. Again, the trial got over 4.5 years ago, but no guidance on US application. US is 20 X of UK in terms of revenue potential. US represents over 50% of the world’s revenue in oncology therapies.
One reason could be that they're understaffed and unable to handle both agencies at the same time. They might want to move forward with the next steps, thinking that MHRA approval will improve their chances with various agencies and approvals. One thing is certain: all of us—investors and patients—have lost out on the vaccine due to these delays.

-Responding to myself to add a correction—I posted the wrong Roswell link for the excerpt:


https://www.roswellpark.org/newsroom/201909-roswell-park-moving-unique-immunotherapy-platform-forward-642-million-dod-grant

Dr. Kalinski of Roswell and Dr. Czerniecki of Moffitt are named together and credited with the development of dendritic cell technology on both the Roswell website and Moffitt website. They are coauthors of some peer-reviewed articles too. 🤔

National Cancer Institute Employees Can’t Publish Information on Vaccibe/oOther Topics Without Special Approval: Vaccines. Fluoride. Autism, peanut allergies and 19 others.

https://www.propublica.org/article/national-cancer-institute-flagged-topics-vaccines-autism-rfk-jr

As an investor, I care about relentless execution and don’t want to hear excuses and victim mindset. If the management team was serious and earnest, they would have submitted reimbursement evidence in parallel or within a quarter or so after MAA submission. Particularly when MAA took itself took over 3 years to submit from the data lock. The trial got over 4.5 years ago.

A company that was serious would have also submitted to another regulatory agency such as FDA and EU. Again, the trial got over 4.5 years ago, but no guidance on US application. US is 20 X of UK in terms of revenue potential. US represents over 50% of the world’s revenue in oncology therapies.

Why would any investors back such a company when all they do is complain, provide excuses, and dangle carrots.

If this current dilution is C-share investors converting to common, and if C-shares have a 90-day restriction on conversion to common, then the common shares being added now are due to C-shares that were purchased 90 days or more ago? So is this dilution occurring now a reflection of more investors wanting to buy C-shares 90 or more days ago? Or of previous C-share purchasers currently wanting to have common shares in their trading accounts?

I am hoping we receive UK approval before the end of this month. Lets see.

“It's been said that the FDA could easily take six months to determine how to make 4 minute eggs.”
Unfortunately, this statement made me laugh and cry at the same time. What’s worse, cutting the budget will not help.

Haha, you don't need to lecture me. I know who to discuss things with. Have I ever asked you anything? I already know what kind of person you are. 😁

Always good to know who is long and short. Have you figured out, I think.

Don't reply as others likely have ya figured out too

That’s a good question. The point I was making to Ex is that the Dallas Carroll story is great news and represents some proof of concept, even though the technology is not owned by NWBO.

That said, there are significant and interesting connections between Roswell and Moffitt, and it seems logical that the foundational research behind their respective platforms might overlap.

Moffitt is one of the sites for a Roswell DC study, and Dr. Kalinski (Roswell) and Dr. Czerniecki (Moffitt) have collaborated on DC technology. Their names even appear together on a patent application related to DC tech. Perhaps there may be further collaboration between Moffitt and Roswell—or perhaps not.

Maybe more will soon come to light on the topic of Moffitt & Roswell 🤔



The Moffitt DC technology used to treat Dallas Carroll in the news story I shared appears to be owned by ImmunoRestoration which is not a publicly traded company.

https://www.immunorestoration.com

https://www.roswellpark.org/newsroom/202311-novel-immunotherapy-approach-roswell-park-shows-promise-metastatic-triple-negative

https://www.sec.gov/Archives/edgar/data/946644/000149315219014466/ex99-1.htm

It is a young Linda Powers

Who's that beautiful lady (face) added in the middle of the picture?

The Magistrate stated: "Application denied without prejudice. The Court has received Defendant's request for oral argument and will take Defendants' request under advisement. The Court declines to order oral argument at this time. The Clerk of the Court is directed to terminate the motion pending at Dkt. No. 186."

Investor82,
#1 It looks as if the MTD even with almost 40 attorneys on the Defendants, will be in whole or part will be DENIED! That’s a pretty strong indication the suit is LEGITIMATE.
#2 The amount of time between data lock and Approval is different for each and every trial. GOOGLE it.
#3 NWBO is a pre Revenue BIOTECH investment. Unfortunately, trials can take over 10 years to complete. Fortunately, we are at the end of the submission phase and are awaiting approval. There are many reasons this trial took longer than most. The primary reason is it takes five years to get five year results. Most trials have projected results. This trial does not and one cannot argue with the results. It’s amazing how you have twisted the truth.
I would suggest that you read the Journal Article endorsed by the 73 Coauthors. It’s impressive to say the least.

OK it is March . . . when is approval????
Didn't they say March????
We're ready Big Time
22 Black and Leave it there.

Don't respond. If you do, you'll receive another message explaining even further. 😁
Anyway, we need the MHRA approval first—any idea when it might come?

Liar! Kite was approved by FDA and they could only manufacture for 100 patients in the first year. No regulatory agency will expect volume manufacturing as part of an approval process. Companies would go bankrupt before submission if it was made mandatory.

FDA and other regulators care about quality control, not volume! If LP ever gave this as an excuse, she would be sued right away! Either way, a lawsuit is coming later this year in Q4.

Did anyone post the Order on Oral Arguments from Last week? Did the Judge rule against?

I know that the bashers don't want to believe it, but the UK was the only one of the four regulators that ran the trial that they could file with. Why? Because the UK was willing to accept a few tiny cleanrooms as meeting minimum commercial production capability before the overall submission was made. All the other regulators have inspection of the commercial production facility as a part of the approval process, and without building thousands of tiny cleanrooms, the approval of the EDEN unit is mandatory to establish an acceptable commercial production facility.

I cannot say where we are regarding acceptance of the EDEN. I believe that Sawston has new large cleanrooms that are ready for many EDEN's to be installed. I also believe that companies, like CRL, have cleanrooms, and other capabilities needed for commercial production available once the EDEN is approved.

I would hope that once approved the company has contractors ready to mass produce EDEN units in hundreds, or even thousands a month.

I cannot say whether the UK is leading all the regulators in evaluating the vaccine in a multi-national effort, nor can I say if the EDEN has been somehow rolled into the UK approval, but barring that, it would be impossible to have an approval by more than the UK.

I would hope that the EDEN is being evaluated in a multi-national effort, not just the UK acting alone. If not, I still believe that others will be moderately quick to accept it once the UK has, but anyone who's dealt with the regulators should understand that moderately quick could easily be six months or more.

It's been said that the FDA could easily take six months to determine how to make 4 minute eggs.

Gary

Sky,

Can we relate this to our patent protection? I see this is Moffitt and not roswell..

Tia