[seekinganswers]

Your unicorn delivery is on the way.
Estimated delivery date is July 19, 2089.

[seekinganswers]

Fact check: True

[SkyLimit2022]

ASW,


I’m a “bagholder” if you say so—the legendary tote! 😉





AI Fact-Checking



🍋

[AllSheWrote]

Maybe you should go back a little further. I get much more specific. But none of it matters with you anyway. You're just one of life''s bagholders! Just the way it is.

[SkyLimit2022]

ASW

Sure—boiling water ..or “circling the drain” or “dead in the water” ..Have you read any of your own vague random posts since your alias was born a week ago? Your fact-based well-sourced posts are so much more clear and specific 😶 …

Gems of insight & pearls of wisdom—that’s all she wrote



AI Fact-Checking

🍋

[AllSheWrote]

Yes, that's what this is! Just like a pot of boiling water! Why didn't I ever see that? Thank you so much for making everything clear.

[Chiugray]

SkyLimit, All that "free advice" from Shorts makes me think of this.

The Boiling Water Lesson
A father had two daughters and one suitor. He told them: "Whichever daughter's pot of water boils first gets to marry him."
One daughter desperately wanted to get married, so she kept lifting the lid and releasing heat each time. The other daughter, who didn't want to marry, never opened her pot - and her water boiled first. Ironic.

The Investment Truth
Due diligence is like adding heat to a pot of water. It is the science. Be wary of Short's "free advice" to get you angry and start second-guess yourself. Don't lose your DD by opening the lid and turning all that converted energy from liquid to gas into wasted energy.

No matter how much heat one puts on NWBO, the DCVax-L approval is with the regulators. One can't increase the temperature of water above 100 degrees with impatience.

The shorts know this. They're not trying to out-research; they're trying to gift Retail investors "free advice" - a Trojan Horse of anger and impatience. They know even investors with solid DD will sabotage themselves if made restless enough.

For NWBO: The science will determine the outcome, not daily price action, not being anxious. Do your DD. Trust it. Then keep the lid closed and let the energy build.

[meirluc]

Thanks erg1 but with all due respect to ChatGPT how can FDA's approval
arrive within a few weeks (August 18, 2025), when no BLA has yet been
submitted to that Regulator and on top of that, MHRA's approval could arrive
much later than August 18 (later this year)?

[AllSheWrote]

Nope! Not the one you're hoping for anyway.

[RobotDroid]

Not the decision you think it is.

[SkyLimit2022]

zero82,

Thanks for reposting your free advice 😶



Where are all of your Chicken Little psychic predictions coming from? I thought you advised us to stick with “only hard facts” 😶




🍋

[Investor082]

Ain’t happening in Q3 for sure. It’s more and more looking like NWBO is unable to address all the concerns of MHRA anytime soon and we may not get approval this year.

Teens coming in August, and all time lows coming in September. As soon as the 17M shares are dumped, the downwards journey will be swift in a couple of weeks.

[Investor082]

It’s clear they won’t apply to FDA. They are going to get pinged with a lawsuit later this fall!

[Sammy 967]

Wow. We have a lot of newly created users- brashers. . I guess decision must be very close. 

[JTORENCE]

erg61 "FDA’s decision in the U.S. is expected by August 18, 2025"
Are you that misinformed ? They haven't even submitted to the FDA.
Go back and read what you posted and rethink using ChatGPT in the future.

[SkyLimit2022]

ASW,

Thanks for the reply 😶

You don’t have to “communicate” with “people like me” …instead try Nature Communications 😉

I agree—it is like a “dreamworld” .. amazing how cell-based science is advancing in this brand new era of COMBOS! NWBO is on the cutting edge along with UCLA, King’s College, University of Pittsburgh, and Roswell Park.

Moffitt is also an important institution and has been a key collaborator with Dr. Kalinski and Roswell—we’re hoping to see more news about further collaboration with Moffitt!

Here is a follow-up link to my previous post about BioForge for your viewing pleasure. (There’s nothing dreamlike or “delusional” about it—it is real 😉).

In addition to the publications linked below, Roswell’s DC technology & UCLA’s platform have been continuously peer-reviewed under funding awarded by the U.S. NIH and the U.S. DoD.



Nature Communications


JNS


JAMA Oncology

Dendritic Cells in Cancer Immunotherapy: Vaccines, Live Adjuvants and DC-assisted T Cell Therapies

⭐️ DCVax-L Combo PII UCLA

⭐️ DC Combo PII Roswell Park

NWBO 10-Q

NICE UK 🇬🇧 DCVax-L

ASM June 29, 2024

Manufacturing Technology

AI Fact-Checking

🍋

[RobotDroid]

Sounds you got a drunk bot there. AI is still progammed by humans...so...garbage in garbage out. That FDA guidance is about a year off.

[AllSheWrote]

You live in a delusional dreamworld. Unfortunately, people like you are just too difficult to communicate with.

[AllSheWrote]

Good luck with that!

[erg61]

When can we expect DCVax-L to be approved?ChatGPT said:
 The most current information suggests that:




What’s next?



Bottom line:
DCVax-L is likely to gain UK approval by late 2025, and the FDA’s decision in the U.S. is expected by August 18, 2025. Still, timelines can be shifted due to regulatory reviews or new data. I’ll keep an eye out for updates—feel free to check back as we approach late summer.

[AllSheWrote]

I think the most shares I ever had was around 90K. Never was invited to join the suit, and never saw a notice to participate. Probably should have.

[AllSheWrote]

Not sure what you are looking at, but this application is dead in the water. You're a fool to consider this anything more than a wildly speculative play that has run out of time. There was potential at one time but, unfortunately, it has been squandered.

[SkyLimit2022]

e❌wannabe,

Thanks for sharing your x-cellent insights 😶

Multiple novel patent-fortified dendritic cell technology platforms that are in-licensed to NWBO are in clinical trials TODAY and patients are being treated TODAY. The fact that NWBO does not need to sponsor or fund those trials is a major win for several reasons:

✅️ No cost (or very minimal cost) to the company
✅️ Independent scientific validation by peer-reviewed grants (U.S. NIH & U.S. DoD)
✅️ U.S. government agency investment/buy-in

Combos with commercialized agents such as checkpoint inhibitors represent a relatively recent development—those studies have reached PII as of 2025. Undoubtedly, more combo trials are coming, potentially funded by NWBO and/or industry partner(s). However, it is misleading to suggest or imply that there are no trials today involving the DC technology platforms owned by the company. NWBO’s platforms have been under continuous clinical development for many years, and we have now entered an exciting new era of COMBO research. Another significant development is NWBO’s recent acquisition of commercial licensing of technologies originating from Pittsburgh and developed at Roswell Park!


Dendritic Cells in Cancer Immunotherapy: Vaccines, Live Adjuvants and DC-assisted T Cell Therapies

⭐️ DCVax-L Combo PII UCLA

⭐️ DC Combo PII Roswell Park

NWBO 10-Q

NICE UK 🇬🇧 DCVax-L

ASM June 29, 2024

Manufacturing Technology

🍋





















AI Fact-Checking

[SkyLimit2022]

ASW,

LP is a shareholder. You can bet that the Harvard lawyer has plans for her shares and cares about their value. Her CDMO, Advent, also owns shares…

Why might Linda Powers have believed that shares of NWBO constituted an acceptable form of compensation for services rendered by Advent? 🤔

Advent & LP have a vested interest in NWBO’s success, which includes their ownership of NWBO shares. Cognate & Advent provided essential support for NWBO during the clinical development of the DCVax-L platform.

LP’s ability to build successful CDMOs is reflective of a skill set that is immeasurably valuable to a pre-commercial biotech like NWBO. Her business acumen & strategic vision also resulted in the acquisition of Flaskworks which is owned by NWBO today. EDEN is a patent-fortified novel manufacturing technology that may add a vast amount of additional value to the company.

In the rapidly expanding cell-based technology industry, Charles River could be involved in some capacity in manufacturing one or more of NWBO’s products for a regional market (conceivably).

https://www.adventbio.uk/

https://www.criver.com/

Beyond Charles River & Advent, renowned research institutions in the U.S. are increasingly investing in built-in manufacturing capabilities to streamline & support the clinical development of cell-based therapies (this wasn’t the case during the early development of DCVax). Examples include Roswell Park’s newly opened manufacturing facility, and the University of Pittsburgh’s BioForge, another state-of-the-art biomanufacturing center currently under construction…

$100 Million to Fund Pitt BioForge


Pitt BioForge


Roswell GMP Engineering & Cell Manufacturing

[Chiugray]

FeMike, it is genuinely insulting and unacceptable to change a legitimate poster's name to "bot" or "Slavebot." Slave1 provides valuable insights, thoughts, and due diligence, and many of us here immensely appreciate those contributions.

Unfortunately, a small group consistently uses fear, uncertainty, and doubt (FUD) tactics. They harass genuine contributors with sneering, manipulative responses designed to stifle participation. This behavior is illegitimate and detrimental, especially to us retail investors who are put our hard-earned money to NWBO with the potential to be a unicorn and help cancer patients.

To all legitimate posters: Stay strong! The science and ecosystem behind the DCVax technology platform are growing broader and stronger with every new reveal. Keeping our fingers on the pulse is exactly why we're all here. And from what I see, DCVax-L approval by the MHRA is only a matter of when, not if.

[learningcurve2020]

…Oh, just remembered, I think you sold before that??

[learningcurve2020]

With all the shares you had why didn’t you joint the True-up suit?

[Doc logic]

exwannabe,

No, actually the advantage goes to the one most ready to provide stunning results quickly and have tissue agnostic labeling in hand while also having the manufacturing, product release and import/export requirements to meet demand in place for the whole line of products. The right process and manufacturing is the advantage, not how many trials can get started; ). Best wishes.

[exwannabe]

Neither.

[Doc logic]

Slave1,

Just a reminder that you first suggested that a published variation assessment timeline would be expected if a variation was in play then pulled back from that when realizing that exceptions could prevent that from happening while ongoing assessment was occurring. The interpretation in light of this is that the possibility of Flaskworks consideration might still be ongoing and that we might not be just waiting on final labeling but also on the variation assessment that needs to be done before this. I am not pointing this out to say that you are incorrect with your suspicions that the review is in the final stages of review with labeling, we don’t know for sure, only that there still might be time involved with an undisclosed variation assessment before that is worked out and that was not being considered until I mentioned the exceptions to disclosure possibility. By the way, a couple of cryptic posts recently seem to point more to what you have been saying, ). Best wishes.

[jesster64]

"NWBO has not run a trial in decade."

run, or been part of?

[seekinganswers]

Salaries, rent and bills are paramount . Shareholders be damned.

[RobotDroid]

It's more like halfway down the drain.

[AllSheWrote]

NWBO is circling the drain, and company officials are too scared to communicate with shareholders. Not a good situation.

[exwannabe]

That is nice that UK is reforming laws on clinical trials to make them easier to run. But what does that have to do with NWBO?

NWBO has not run a trial in a decade.

[seekinganswers]

NWBO is stuck the in the variation dept. waiting to get the newly revised PIP trials approved - then MHRA will reject bc of the external controls debacle in the Phase 3 trial.
Which is also why the PIP trials were rejected by clinicians.

IMO

[exwannabe]

So NWBO has added Eden to the MAA when they do not even have the actual GMP version of the device delivered and are awaiting that to start testing.

Solid theory there slave.

[AllSheWrote]

LP has done a remarkable job of using shareholder funds to start up two successful CDMOs that have rewarded her, her husband, and their little investor group very handsomely. Other than that she hasn't invented jack s--t.

[exwannabe]

Interesting. Based on the timeline, on Sept 19, 2018 there was an example of NICE previously suspending the appraisal. This seems to verify everyone's contention that the submission is forthcoming. 👍️

And it was reactivated in Dec 2022.

And posters said it must be close at that time based on the NICE action.

Have a nice day.

[exwannabe]

“The dendritic cell revolution has begun.” – Dr. Thomas Ichim

If that is true, then the advantage goes to those who have been and are running trials.

NWBO has not enrolled a patient in a trial in 10 years. The -L we are talking about now was from 2001.

But they are doing a great job of building CDMO's for LP.

[barnstormer]

Thanks for the response Slave. I was thinking of SEC requirements and that the addition might fall under Regulation FD guidelines, or at least was significant enough that an 8K would have been warranted.

[QuantumRebel88]

Interesting. Based on the timeline, on Sept 19, 2018 there was an example of NICE previously suspending the appraisal. This seems to verify everyone's contention that the submission is forthcoming. 👍️

[Doc logic]

AllSheWrote,

I don’t think exwannabe is going to back you up on that claim; ). Best wishes.

[seekinganswers]

Wrong!!! Linda Powers invented 1.7 BILLION SHARES OF STOCK,.... Out of thin air

PS. DocLogic is a colossal fool, IMO

[abeta]

02 April 2025

NICE is continuing to liaise with Northwest Biotherapeutics. The company reports that it is still fully occupied and engaged in the Marketing Authorisation Application (MAA) process with the MHRA.

https://www.nice.org.uk/guidance/indevelopment/gid-ta10143

[Chiugray]

“The dendritic cell revolution has begun.” – Dr. Thomas Ichim

GANDALF: The tide is turning. I can feel it in the immune system... in the very cells themselves.

SARUMAN: You feel it, don't you? The old world? Or is it that cancer is growing stronger, and so are the new drugs.

GANDALF: You speak of chemo and such drugs that bypass the immune system and therefore create many risks for severe adverse events to patients, that do not cure the underlying cancer. I speak of dendritic cells, of DCVax—a personalized therapy that informs the body, that activates a broader and more effective holistic immune response.

SARUMAN: For too long you underestimate the destructive power of chemo.

GANDALF: Chemo treats the symptom, but it allows the cancer to adapt, evolve, and return stronger.

SARUMAN: Then more chemo and drugs.

GANDALF: The age of chemo is passing, Saruman. DCVax-L stands on the cusp of approval. The dendritic cell revolution has begun.

[AllSheWrote]

Insane that you would dismiss the first option, which is by far the most plausible. We all know MHRA sent the application back with stipulations that are impossible for NWBO to meet. You can dismiss that option at your own peril.

[Roman516]

NoGrow, your opinions have zero value.

Once again, your wrong per normal, IMO
Your comment,
"No way in hell is Parliament going to get involved in a MHRA drug review"

New clinical trials regulations laid in parliament today
https://www.hra.nhs.uk/about-us/news-updates/new-clinical-trials-regulations-laid-parliament-today/
"The laws which regulate the way clinical trials are carried out in the UK are changing.

We've been working with the Medicines and Healthcare products Regulatory Agency (MHRA) for the past two years to draft proposals to update clinical trials regulations.

Today we reached a milestone in that process. The statutory instrument to amend the Medicines for Human Use (Clinical Trials) Regulations 2004 has been laid before Parliament.

The updated regulations will be debated in the new year and after a 12 month implementation period will come into force in early 2026.

Updating this crucial law started in 2022 with a public consultation which asked for feedback on how the regulation of clinical trials could be improved and strengthened in the UK.

We’ve been working with the MHRA to use that feedback to update the current regulations to create a faster, more efficient, more accessible and more innovative clinical research system – making the UK a world leader in clinical trials."

https://commonslibrary.parliament.uk/research-briefings/cdp-2024-0172/

[AllSheWrote]

WTF are you talking about? She hasn't invented anything.

[jesster64]

It seems there are 3 sides of the track right now.
1. application is a failure and MHRA is losing patience and will soon reject.
2. MHRA was waiting for new legislation and protocols to go into effect before approving, which explains the delay
3. MHRA and NWBO are working together to expand application to encompass not just glioblastoma, which also explains the delay

There is no use name calling and trying to justify ones point of view. It is what it is. We can eliminate the first scenario because rejection would have taken place long ago. Approval is very close. It doesnt matter what the delay was, once approval occurs, the real show begins.
Approval is the key, the main course. Approval for multiple cancers would be the buffet. We are very very close to dinnertime. In between we are trying to figure out what makes the most sense. The best we can do is look at the facts, NWBO submitted and it has not been rejected or approved by MHRA. The rest is just spitting in the wind until a new fact appears.
I am now off my pulpit and need to check on my chicken legs which I am smoking.