Northwest Biotherapeutics Inc (QB) (NWBO) News

Do to TO censorship of free speech, I've left out the handle of this "X" post.

It appears the Defendant Market Makers,
@MerrilllLynch and @cibc, do not want the number of alleged spoofing episodes to be made public. They're already public. See above.
"We write on behalfof Defendants under this Court's direction in the November 25 the Court maintain under seal references in the Order & Opinion to the specific
numbers of alleged spoofing episodes that Jonathan Brogaard, Harington's proffered liability expert, attributed to Defendants' customers in his reports!"
See Image 1.
Part of the Court's opinion with the recommended redactions are seen in
Image 2.

The image referenced can be found on original post.

We are in agreement, and thank you for your well wishes.

I have no handlers; I'm not paid to be here. I'm simply an investor who's here to learn from other investors... and call out paid FUDsters. Pretty sure you own no shares... 👿☠️

The TRUTH has been destroyed by Flopper and his cohort. 

I guess better than your handlers 

Your handlers never fail! 👿☠️

Ohh so sweet . Do you want me to post links to your calendars and infinite updates over last 5 years , and SWIFT posts and lot more . 

I will look for tutor ... "Pronto" ... 

Lol
Says featherweight ... persona non grata . 

Yes your honor . Whatever you say 

As predicted and expected , closed red 

Sorry. No time for lightweight. I have a bunch of your buddies on the ignore list and you can have fun with them.

I like LP is in radio mode. If she can lead the company and make it survive on OTC for such a long time, she can lead the company to enormous success too. Until then, the longs just need to wait and we have the patience. Do all these BPs have the patience?

I encourage you to get a tutor.

And he never shows up.

dstock07734,

Business decisions don’t always match up with generally expected values. Whether additional expansion costs to meet demand vs keeping prices higher with reduced supply can line up with business profit or humanitarian values generally heads towards profits and or survival. It’s pretty obvious Merck was not trying to keep up with demand just from what we have read from shared due diligence on the subject and a testimonial on this board from Laser777. Best wishes.

You are on to something. I don't know the answer. But, I wished LP would have said something about the replacement t for BCG.

Sure let Flip know who has a new big point every week to explain the delay 

In Direct, BCG cell wall skeleton is in combination with GM-CSF.

How about Epacadostat as a replacement for BCG?

https://www.frontiersin.org/journals/pharmacology/articles/10.3389/fphar.2022.954955/full

I hear the Gen 2 has twice the ORR! Still zero, but 2x0.

Great News Next Week!
Or maybe the week After.
Or next month.
Or the month after.
Or the month after that.
When you are long it’s an endless timeline.
Waiting for Godot.

Looking forward to learning about the alternative maturation agent (booster) they found for Direct. Whether it be a different strain of BCG, poly-iclc, IL-7 or something else.

Come on miltong.
Just stop going Starbucks for one day. That should cover your loss.

Pardon me for being ignorant.

Why is this BCG thing so important? LP just found a better replacement that can yield better efficacy. It is just that simple.

People have been hailing neoadjuvant therapy as a big break through. NADINA is hailed as one of the 11 clinical studies with the biggest impact on health care in 2024. Georgina Long who was involved in the trial gained international publicity because she used the combination from NADINA trial to treat her colleague's GBM. Yes, neoadjuvant therapy can cause t-cell infiltration. But is the t-cell infiltration massive and sustainable? The answer is obvious as shown in the following figure.

Merck is one of the collaborators in the combo trial and should know all the first-hand data. Merck knows that for the first time with DCVax-L Merck can explore the cold-tumor domain which will bring Merck enormous revenue. Merck would beg for being a partner whatever the price is. It is just unbelievable Merck would make BCG a problem.

I am not so lucky. I had to raise my bid to get one lot @0.275 and another lot at @0.2734. Probably I was impatient. But that's ok.

You got the presents!
Congrats!

You think the longs are pumpers? Do you know how ignorant you are?

Let me tell you something simple enough for you to understand.

You know what the following figure is about? This is from the combo trial about t-cell infiltration after the administration of PD1 inhibitor. The red dots are infiltrating t-cells. Blue dots are cancer cells and green ones are macrophages. Can you see a lot of red and green dots? I cannot. But I do see a lot of blue dots.


Here comes the second figure taken after DCVax-L was administered. Obviously there are a lot of red and green dots. Can you see the blue dots have become much less denser? You know why? It is because the infiltrating t-cells have eliminated tons of them. Do I need to lecture again how to deplete those green dots so that t-cells can wipe out all the blue dots?



I combine the two figures and you can take a closer look.



Have you read the latest abstract on the combo trial?
https://jitc.bmj.com/content/12/Suppl_2/A927


Methods To investigate this mechanism of immunotherapy resistance, we performed single-cell RNA-sequencing (scRNAseq) on pre- and post-vaccination tumor-infiltrating immune cells from three recurrent GBM patients enrolled in the ATL-DC + neo-aPD1 clinical trial. Additionally, we integrated our previously published and newly generated scRNAseq data encompassing 21 immunotherapy-naive and 23 neo-aPD1-treated recurrent GBM samples for comparison, representing the largest single-cell resolution analysis of the GBM immune microenvironment to date (n = 50).

Conclusions This study reveals that timing may impact how ATL-DC and aPD1 combined therapies can alter the immune landscape of GBM and highlights tumor-associated macrophages as a major obstacle to clinical benefit. Future strategies targeting these populations or blocking their immunosuppressive interactions with anti-tumor CD8+ T cells hold promise for improving the efficacy of immunotherapies in GBM.


Is it obvious that the data from the combo trial should be included in the filing package? Ever wonder when the analysis was done. I can tell you. It was done in 2021.

Thanks to the manipulation machine, grabbed another 10k shares at .27.

I am in agreement that Merck’s BCG supply problems caused patient treatment delay, shortages and in some cases outright unavailability. I think you may have misread the quote I posted as it was actually saying shortages were no random, and with regard to research centers, some were shorted as well. Perhaps we are in agreement.

I wish you nothing but the best.

That is incorrect.
I had bladder cancer, and treatment was delayed, and when I did get treatment, it was 4 treatments, instead of the SOC of 6.
BCG shortage was the excuse given.

Collusive manipulation as expected and predicted. 👿☠️

Let's see you prove it was released as a press release.
So now you deny NWBO issued this PR?

1) I can not find any Ihub post in which there is a link to an NWBO press release
There were dozens. Just go to that day and look through the posts.

2) There are links to PRNewswire and other news sites.
Found it on first hit on first search,

You have to got to be a short just trying to make longs look bad.

BTW, Still waiting for you to abide by your bet on the MAA being approved by August 2024.

Just wondering if we can benefit from another Zoom call before it gets crazy around here.

It will get crazy, so many posts during the day it will be hard to read them all.



Don't Make Me Leak

Here's an interesting BLA submission to keep track of as a gauge of FDA flexibility. AstraZeneca and Daiichi Sankyo have shared the data they believe can secure approval for datopotamab deruxtecan (Dato-DXd) at the second attempt. The partners showed off subgroup overall survival data that exceeded the result seen in the broader population, providing evidence to support the pivot.

Originally, the partners applied for FDA approval of the antibody-drug conjugate (ADC) in patients with advanced or metastatic nonsquamous non-small cell lung cancer (NSCLC). Last month, AstraZeneca and Daiichi withdrew that filing and resubmitted for approval in a subset of patients with EGFR-mutated NSCLC. They are pooling a subset of the P3 data (i.e. EGFR mutated) w data from a P2 trial.AstraZeneca and Daiichi included 117 patients in the analysis: 78 from a phase 2 study in patients with actionable genomic alterations and 39 from a broader phase 3 trial. Median OS in the overall population of the phase 3 trial was 12.9 months, a result that was statistically no better than the 11.8 months seen in the control arm.

Median progression-free survival (PFS) was numerically higher in the pooled analysis, 5.8 months, than the phase 3 trial, 4.4 months. And a bump in the response rate, from 26.4% to 42.7%, wrapped up a set of data that suggests Dato-DXd is more effective as a later-line treatment in people with EGFR-mutated NSCLC than in the wider patient population....

...Susan Galbraith, Ph.D., executive vice president of oncology R&D at AstraZeneca, discussed what the FDA made of the data on an earnings call after disclosing the withdrawal and resubmission last month. The FDA has “noted the favorable benefit risk profile in EGFR-mutated lung cancer,” Galbraith said, and “is interested in the particular subgroups where the greatest benefit is seen.” That interest led the FDA to EGFR. https://www.fiercebiotech.com/biotech/astrazeneca-daiichi-share-data-behind-dato-dxd-do-over-amid-second-bid-lung-cancer-approval?utm_medium=email&utm_source=nl&utm_campaign=LS-NL-FierceBiotech&oly_enc_id=4891B5384067C3X

I asked Co Pilot how to pursue a Tissue Agnostic Designation for DCVax-L

To pursue a tissue agnostic designation with the FDA, you need comprehensive data demonstrating the drug's efficacy and safety across multiple cancer types with the targeted molecular alteration. Here's a detailed overview of the data required:
Clinical Trial Data:
Robust Evidence: Data from multiple clinical trials showing the drug's effectiveness across various cancer types with the targeted molecular alteration.
Subgroup Analyses: Detailed analyses for each cancer type to demonstrate consistent efficacy and safety across different populations.
Biomarker Analysis:
Targeted Biomarker: Thorough characterization of the biomarker(s) targeted by the drug, including its prevalence and role in different cancer types.
Mechanism of Action: Clear explanation of how the drug interacts with the biomarker to exert its therapeutic effects.
Preclinical Data:
Supporting Studies: Preclinical studies, such as animal models or in vitro experiments, demonstrating the drug's potential efficacy in multiple cancer types.
Mechanistic Insights: Data providing insights into the drug's mechanism of action and its effects on various cancer cells.
Scientific Rationale:
Cross-Cancer Efficacy: Strong scientific rationale explaining why the drug is expected to be effective in multiple cancer types based on shared molecular pathways.
Pathway Analysis: Detailed analysis of the molecular pathways involved and how the drug targets these pathways across different cancers.
Safety Profile:
Comprehensive Safety Data: Data showing the drug has an acceptable safety profile across different cancer types.
Adverse Events: Analysis of adverse events across trials to ensure the safety profile is consistent.
FDA Guidance Documents:
The FDA provides specific guidance on tissue agnostic drug development. You can refer to these documents for detailed recommendations:
Generalizing Treatment Effects in Confirmatory Clinical Trials: Guidance on generalizing efficacy from observed data in some cancer types to others with the same molecular alteration.
Developing Targeted Therapies in Multiple Cancer Types: Guidance on the development of targeted therapies across different cancer types.
Collecting and presenting this comprehensive data is crucial for obtaining a tissue agnostic designation from the FDA. It's advisable to work with regulatory experts to ensure your submission meets all the necessary requirements.

1pm and nwbo is about 125k short of the approx 1 million daily shares it needs to pay the bulls.


P to the M.

I asked Copilot - Could the submittal for DCVax-L to the FDA include an agnostic designation?

Yes, the FDA does allow for tissue agnostic designations for certain drugs. A tissue agnostic drug targets a specific molecular alteration (biomarker) across multiple cancer types, rather than being specific to one type of cancer
1
. This means that the drug can be used to treat different types of cancer that share the same molecular target.
For example, pembrolizumab was the first drug to receive a tissue agnostic approval for patients with unresectable or metastatic, microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumors.
To pursue a tissue agnostic designation, the submission to the FDA should include comprehensive data demonstrating the drug's efficacy and safety across multiple cancer types with the targeted molecular alteration. This involves a thorough understanding of the molecular pathways involved and robust clinical trial data.

I have every expectation that Direct development will restart in 2025
I would be very surprised to see first patient dosed in 2025.

Mainly is the manufacturing. They have tasked Advent with either finding a way to refurbish the 12+ year old TTF equipment used in the previous P1, or else find a commercially available alternative. The former might prove difficult and/or timely. The later will certainly take some time. Whatever they do, they need to get it evaluated and in, and then GMP approved at Advent prior to the trial.

We also know nothing about the process to switch to "DCVax-Direct Gen 2", that also could impact times.

And if for some reason they actually decide to evaluate alternative maturation agents, that could go a couple years.

Even when NWBO had all the MFG in place and plans set to run trials they failed to launch several times in the past.

Let's see you prove it was released as a press release.

1) I can not find any Ihub post in which there is a link to an NWBO press release

2) There are links to PRNewswire and other news sites.

3) Walking through all snapshots for 2023 on the Way Back Machine shows NO press release of this on NWBO's website during 2023.

You said there was one?

Be my guest and trawl:

http://web.archive.org/web/20230601000000*/https://nwbio.com/press-releases/

So who is lying?

NWBO or you?

Well, having had a solid loosing streak in the factual circumstances arena since you created your fud account here, my odds would be on the latter.

But ... I'm always keen on getting refuted by evidence. Its just so seldom we see anything but bullshit flaunted from you fud lot.

Bored again huh? Needed to somehow bullshit something for a couple of paid shill quid?

Yeah happy whining day 👍🏻

I asked co-pilot about the long tail with DCVax-L
The "long-tail" in clinical trials refers to the extended survival observed in a subset of patients who live significantly longer than the median survival time. In the context of DCVax-L clinical trials for glioblastoma, the long-tail represents patients who have exceptionally prolonged survival times compared to the average
2
.
Key Points on Long-Tail Survival with DCVax-L:
Extended Survival: In the Phase 3 trial, a subset of patients exhibited survival times well beyond the median overall survival (mOS) of 23.1 months.
Significant Extension: Some patients lived for more than 30 months, with a Kaplan-Meier derived mOS of 46.5 months.
Not Explained by Prognostic Factors: The extended survival in this subset of patients was not explained by known prognostic factors, indicating a potential unique benefit from DCVax-L.
Safety Profile: The treatment showed a benign safety profile, with adverse events comparable to standard therapy alone.
This long-tail survival is particularly encouraging as it suggests that DCVax-L may offer meaningful survival benefits to a subset of patients who might not respond as well to conventional treatments.
Would you like more detailed information on any specific aspect of the long-tail survival or the clinical trial results?

What percentage had a long tail?
In the Phase 3 clinical trial for DCVax-L, 30% of patients lived for at least 30 months, and 24.2% of patients lived for at least 36 months. This indicates a significant long-tail survival benefit for a subset of patients treated with DCVax-L.
Would you like more information on the trial results or details about the patients who experienced long-tail survival?

Even cancer patients have not been able to get TICE BCG on occasion, and you just brush off small companies and research facilities having to go without and find funds for another version (not approved or manufactured here) to go elsewhere and start over with something else, and why would a company pursue an ingredient in yet another trial when the manufacturer hasn’t completed a new facility since 2012 and doesn’t intend to until 2026, and then only slowly.

For example:

August 2019

Nonrandom’ availability
Despite Merck’s practice of allocating [Tice BCG] based on historical purchasing, patterns of shortages have not emerged. In some cases, large academic centers are experiencing shortages, whereas others have plenty of BCG in stock. — https://www.healio.com/news/hematology-oncology/20190805/bcg-a-realworld-example-of-health-care-rationing

Red as expected and as predicted 

we’d be looking around between two weeks before to two weeks after Trump’s inauguration


I would tend to agree with this, although I have been hoping for a positive decision much sooner.



I personally think with all the talk about how prepared they were, that they would have responded in 60 days to an RFI.

Yeah, however I would have thought they would have submitted a lot sooner than December of 2023 given "how prepared they were".

Don't forger they outsourced a lot of the work so we were at the subcontractor's mercy...And most likely at their mercy for RFI to do's. So who really knows?

I asked CoPilot - Can the tumor tissue be exported from the US prior to the UK for storage until MHRA has approved DCVax-L?

Yes, it is possible to export tumor tissue from the US to the UK for storage until MHRA approval is obtained for DCVax-L. However, you must ensure compliance with both US and UK regulations:
US Export Requirements: Obtain the necessary export licenses and ensure the tissue is handled according to US regulations for exporting human tissues.
UK Import Requirements: Ensure that the tissue meets UK import requirements and that you have the appropriate HTA licenses for storage.
Storage Conditions: Maintain proper storage conditions to preserve the integrity of the tissue until MHRA approval is granted.
It's advisable to consult with regulatory experts in both countries to ensure all legal and regulatory requirements are met.

Steady_T Another friggin genius. We on this board are so blessed to have you as a poster ,spewing common sense logic. Please continue...

- There are certain realities when you are processing paperwork. The more there is the longer it takes.[color=red][/color]
-The 333 days is an average. "That means some are longer and some are shorter." -Really we almost forgot on how to figure out averages.

No, but I would think that parsing thru the MAA PR gives clues to the additional data such as proteomics we didn’t expect would be in the MAA. Just the meta data backing up the lab analysis, Pathology reports, Expanded Access Protocol and the pseudo group that was separated out would add… a 100,000 pp or two.
As you may surmise, I don’t have a clue. What will give you a very strong clue is the newly issued FDA guidance that just came out.

Electronic Submission of NDA and BLA Content for the Planning of Bioresearch Monitoring (BIMO) Inspections for CDER Submissions
https://www.fda.gov/media/85056/download

A law without a penalty for not complying is, at most, a suggestion.... hope this works but apprehensive...🤷

dbing - Interesting thought. Money grows on trees in Dubai. One or two Princes, let alone a Dubai based fund could eat the OS for lunch.

This Stocktwits post points to more evidence of manipulation, as a standard practice across tickers. Check out @3Aces4now message on Stocktwits http://stocktwits.com/3Aces4now/message/595408435

Apologist. That means starting over.
LMAO.

You yourself have said there is a Direct Gen 2 ready to be used. Changing vendors is a smaller change than that.

And regardless, they can easily get the Merck version in sufficient quantity to run a trial.

This entire theory is whacky game by LP to misdirect, and anybody who can think it through knows that.

Market cannot go down, nwbo cannot go up.

Almost two decades of l/p and about a 98% loss in s/p.

A disaster performance.

Smh

Apologist. That means starting over.