Northwest Biotherapeutics Inc (QB) (NWBO) News

I actually don't hate anyone, rather, given the closed circle of vested interests within this Trial enterprise, it became necessary to escalate to a higher Authority, no more.
And given that, as evidenced to a Third Party, my rights as a NHS Patient were kicked to the kerb, my actions are proportionate.

You're welcome bio, but all credit goes to Henry Muney.

GLTU

I fully support NWBO's right to take the claims of Market Manipulation to court for arbitration.

It is where matters should, and will be resolved. If it is proven that LP was correct, then so be it, great. And the question of Loss will be quantified.
I have no dogs in the race, in that regard, relating to that that decision. 🤷🏻‍♂️

Methinks that OP is an instance of Spiro T Agnew's "nattering nabobs of negativity". That guy from back in the day was a crook of a US VP but he had a way with words (this was his Inventive name for 'the mainstream media' who were not fond of him).

In any case imo the dude is off his rocker now, obsessively hating on people on this MB. Not at all the sign of a healthy individual dealing with whatever may have happened and moving on with his/her life as I would expect any normal person to. Whatever happened or didn't happen to him he's stuck in a place of negative obsession. That's sad, I guess, but more than anything, batty. Hardly the sign of a reliable narrator, do you think? Suppose he was at some point mistaken for a good candidate for the trial. As you say, to get into the trial a patient has to have tumor material to use to make their vaccine. He didn't have that, hence he never was near getting into the trial. But he's confused now and in his mind, the trial is somehow connected with an imagined persecution of himself. All this indicates clear mental instability to me. A sick puppy, who possibly was recruited to somebody's bashing team or else accepted for himself the identity of a free lance basher and an 'avenging angel auditor' who gets back at his imagined tormentors. One or more screws have surely come loose along the way.

I played your post backwards and finally understood it.

Sprechen sie geek?

Dmb, it may be politics, but frankly I believe the regulators are hearing from the not only the politicians, but also the public, to reduce the cost of developing drugs. I believe the streamlining the regulators are doing is a good start, but frankly they have a long way to go.

I believe that if regulators see with their own eyes that a product is clearly of benefit, with no further paperwork they should be able to issue an EMU that applies until they can review a proper filing and act, or at least for a limited number of years. Any product on an EMU should be sold at a fair price, but each use should be logged in a Phase 4 database which should establish it's efficacy. If negative side effects are seen, it can result in mods to how it's used, or it can be removed from the market. In our case, years ago an EUA would have been possible, the company would have had to build many small cleanrooms, as the EDEN was too far off, but it would still have been very profitable.

Gary

The first time it happened to me I took much of my holdings out of Fidelity and put it elsewhere where I still had margin available. The last time it happened I had very little margin, but rather than making the call, I sold some out of the money calls to eliminate the tiny amount that I'd taken. When IMGN was $5+ I'd had perhaps $50K available in margin, and used a few K, when it suddenly went to over $20 they took all margin away, even the $50K available when the stock was $5 was allowed when it was $20. I called Fidelity at that time and spoke with brokers, with their managers as well, I was assured that none of the broker who made that decision could be spoken with, the decision was made by a group that don't speak with regular investors about their actions.

I really can't say how many companies this happens with, or how often, I only had it happen with IMGN, but heard from others who'd had it happen with other companies, and with other brokerages. My point is, the brokers, like the MM's, can influence the share price with their actions. Today, if brokers who allowed investors to take naked short positions in NWBO, if those brokers acted in a coordinated way to say all shorts had to be eliminated the short squeeze would be magnificent even at these low prices, which wouldn't remain for long. I don't believe any routine investor can do a naked short, but if you're a big enough client, anything may be possible. Of course no brokerage want to destroy the relationship with their biggest customers, so they won't independently act against them. They do have rules, and if their short positions are deeply in the hole the rules force them to have their customers eliminate their short and we get a big, beautiful short squeeze.

Gary

They can't kick out their leadership. They true up themselves and LP is chairman of BOD. It is a just a scam to enrich themselves. That's why this sht is so slow. It is by design....they needed to build out toucans CDMO business TWICE on the shareholders dime and collect their salaries and awards. Unreal but keep preaching that manipulation and other external excuses. You wonder why they don't want to show their commercialization plan because it would expose this self dealing and conflict of interest BS. What is this cost plus 15% show some numbers..don't deal in generalities. Typical BS from this scam company. No transparency or accountability ever from this BS crew.

https://find-and-update.company-information.service.gov.uk/company/08717711/persons-with-significant-control

david vs goliath. Give me a break. Time to start executing once this laughable case gets dismissed. Time to start internalizing/execute and stop these externalizing BS excuses. Was this manipulated for 22 years on this downtrend? Is there any path to profitability here 22 years in? Please.

ae kusterer - We know what the stakes are in the legal case. If we didn't have a predominantly captured and controlled legal system, we wouldn't find ourselves on "pins and needles," as we wait to see what the Judge decides. So we wait.

Tiny broke NWBO to the rescue!!! Come on. Eye rolls.

dmb2

Re: Doc logic post# 706926

Sunday, July 21, 2024 7:39:11 PM

Post#
707465
of 707475
Doc logic, I think FDA has become more political in recent years, it once was the drug regulatory leader in the world regarding its processes and its scientific decision making. That appears to be changing and it has become more apparent that there is more than a noble agenda of protecting the public at play at FDA, sounds a bit like the USA financial markets. The UK has always been quite analytical in its approach and its processes. We always knew at site inspection time the FDA would require massive documents to review at the site while the UK inspectors would take more time to physically inspect the site, and more thoroughly review the physical processing areas and equipment.
The EU has always been a bit of a maze to work with due to the country differences which still exist, though approvals are now more streamlined due to the single process. There are still country level differences regarding labeling, transportation, distribution as well as quality issue resolution though the ICH process continues to reduce major regulatory differences.

All in all it is fair to say what NWBO has undertaken has been a significant set of accomplishments and their strategy will hopefully turn out to be valuable as well as telling regarding how the FDA has slipped. I would love to know more about their pivot to the UK, but that is probably never to be revealed completely.

I am hoping the PIM designation comes through with some prioritization for DCVax-L approval soon.

GLTA

Citadel and the 6 other market makers have bought 90% of the American stock market order flow. With this, they exact a trading tax on American stock market investors. In the case of Ken Griffin-Citadel ,$10 billion a year is their annual profit via algorithmic spoofing and naked short selling .

$nwbo @alphavestcap @hoffmann6383 @kshaughnessy2 @BrianEgolf2 @SmithOnStocks1 @ATLnsider @TiltMyBrain @glen_bwrhr42

If Judge Woods denies Citadel's motion to dismiss(MTD), will that result in Laura Posner's capabilities moving U.S. regulators to finally address the Citadel tax… https://t.co/hggX3CJ8iB— alphavestcapital.com (@alphavestcap) July 21, 2024

The $nwbo-Laura Posner lawsuit against Citadel and the other six market makers (https://storage.courtlistener.com/recap/gov.uscourts.nysd.590344/gov.uscourts.nysd.590344.150.0.pdf)
is being brought to a head by the MTD ruling Judge Woods will make in the next 1-3 weeks. Because the $nwbo case presents the first extensively detailed proofs of pervasive naked short selling and spoofing, Judge Woods' ruling will be one of landmark status (https://famous-trials.com). If he rules to grant the MTD, that will mean the legal system in the U.S. will continue allow this cancer affecting the American public stock trading capitalist system to continue. If he denies the MTD , there will be an ensuing plethora of lawsuits that will root out these manipulartive trading schemes, thereby restoring the stock market to a system where natural supply and demand sets prices.

Considering that the Citadel algorithms have “set" the price of nwbo for at least 10 years, it will take the maa approval and/or the dismissal of the MTD to break that grip. Retail and institutional investors have been scared away from $nwbo’s manipulated trading on the OTC market . And it’s that same grip on 1000s of American stocks that earns Ken Griffin -Citadel $ 10 billion per year. And its his $200 million in annual on campaign cotitrbtuions to Congressman and Senators that keeps securities regulators (SEC, Finra, DOJ) from enforcing laws already on the books. But this David-Goliath war(see
@cvpayne
link below) can be turned in David’s favor by the huge cash that can be generated by Judge Woods dismissing the MTD and the MAA approval allowing the start of the commercial sale of DC VAX L. NWBO’s combination trial data has shown MOS extension from 16.5 months with current SOC to 10 years with the Liau combination formulas (see Allen Turner links below).

Impressive LCM strategy before initial approval! #dcvax $nwbo

DCVax-L + Poly-ICLC. Est primary completion Jan 2024. Unpublished interim results: ~50% survival at >8 YEARS.

DCVax-L + PD-1. Est primary completion Aug 2024. Unpublished interim results: ~65% survival at >26 mos. pic.twitter.com/T0jAwH65Uo— Allen Turner (@AllenTurner206) February 15, 2023 ?

https://storage.courtlistener.com/recap/gov.uscourts.nysd.590344/gov.uscourts.nysd.590344.150.0.pdfhttps://x.com/alphavestcap/status/1814297519473541421

3-6 months is what I am thinking as well but closer to 6 than 3. Would love to be wrong but that’s my intuition.

DCVax is not a brain worm remedy. Never was, which you likely have figured out by now.

Confidence in a company that steadfastly holds to its vision, which included proper selection of study participants.

Tense for you, obviously. My confidence cannot waver.

Nemesis18,

I have a nagging tendency to draw a mental link between some big pharmas, their hedge fund friendlies and many of the ihub NWBO negative posters in my thoughts sometimes based on circumstances. Just like you want your voice heard, I sure would like for discovery in NWBO’s case against market makers to help prove or disprove those rambling thoughts once and for all!; ). Best wishes.

Approval still seems far away with the inspections lagging behind, perhaps 3-6 months. People here thinking it will happen in weeks are deluded and setting up more of the same false expectations so popular on this board. If the mtd is denied, the hedge funds will simply draw out a long legal process, maybe years in the making, especially with no UK approval on the horizon. They are not going to suddenly cave and open themselves to more lawsuits, nor will they privately settle for the same reason. I hate to say it but we may end the year with neither resolved and the stock at 10 cents.

RobotDroid,

Hey, waiting is no fun. We all agree on that except those trying to create gains by decrease but even they are struggling with their attempts to work price down faster here; ). I expect approval to bring the price bump and manufacturing news to bring the really big rally. In the mean time we have lawsuit updates to look towards with MAA news sometime after that being likely. Sure would like any motion to dismiss denial to bring a rally based on likelihood of settlement, even if not going for settlement, and MAA decision to be additive to that. That timing is out of shareholder hands though so not counting on it. Best wishes.

Tense times as an investor ☝️🥴

Doc logic, I think FDA has become more political in recent years, it once was the drug regulatory leader in the world regarding its processes and its scientific decision making. That appears to be changing and it has become more apparent that there is more than a noble agenda of protecting the public at play at FDA, sounds a bit like the USA financial markets. The UK has always been quite analytical in its approach and its processes. We always knew at site inspection time the FDA would require massive documents to review at the site while the UK inspectors would take more time to physically inspect the site, and more thoroughly review the physical processing areas and equipment.
The EU has always been a bit of a maze to work with due to the country differences which still exist, though approvals are now more streamlined due to the single process. There are still country level differences regarding labeling, transportation, distribution as well as quality issue resolution though the ICH process continues to reduce major regulatory differences.

All in all it is fair to say what NWBO has undertaken has been a significant set of accomplishments and their strategy will hopefully turn out to be valuable as well as telling regarding how the FDA has slipped. I would love to know more about their pivot to the UK, but that is probably never to be revealed completely.

I am hoping the PIM designation comes through with some prioritization for DCVax-L approval soon.

GLTA

Gary - interesting. Didn't know Brokerage Houses did that with an equity on a bonified exchange.

On more than one occasion Fidelity suddenly stopped permitting margin on IMGN after it made a major move up

Well, if they have the ASM every 2-3 years or so, they can always have 'news', but they should change the name to the OSM, occasional sh meeting.

learningcurve2020,

You need to go back and look at the numbers for votes cast. The vast majority of long time longs, most heavily accumulated being likely being the “real longs”, voted for all propositions. The numbers speak for themselves, almost no impact from those voicing dissension although certainly noted by management I’m sure because trends can start with a few. By the next ASM there will have been significant news based on very realistic expectations that an approval decision and other news will have been announced by then. Best wishes.

Well Said

Verbigeration is the word I come up when I think of Nemo and what he is trying to say. You can blame his condition.

No. Your arguments are irrelevant.

Still, the board is completely disconnected with what is going on with the company, and is irrelevant as far as NWBO's success.

Parked? It's been stripped! Yet somehow it's sitting at a very respectable $500M market cap since 2020 which is remarkable for a broke-one women show-terrible governance-presentation-less biotech. Retail money isn't parked it's being diluted to death.

>>Our money has been parked in the deadzone for far too long now.

Yes, Coley’s discovery was interrupted by 130 years, including two World Wars, Chemotherapy, and a pharmaceutical industry that lives to put real answers on the back burner — exceptions being hepatitis C cure, polio and other vaccines for communicable diseases.

You’re right, science is ahead of the curve.

learningcurve2020,

It is funny because you are laughing a little too soon and that often leads to extreme embarrassment when the truth comes out; ). Something about he who laughs last kind of thing; ). By the way, I don’t imbibe as you suggest which is just another false insinuation/accusation being piled upon the altar to the “father of lies”. Best wishes.

I can tell you're depressed and probably drinking but please don't make people read through these fantastical diatribes of yours.

Now that is funny!

>>thought they could just have their way with NWBO shareholders.

Thanks ILT,

Frankly it's been many years since many who would have invested in NWBO would consider it again. I'm speaking of a large percentage of investors who won't buy penny stocks, and many in that class consider anything under $5 a penny stock. This of course also includes probably over 90% of Institutional Investors. Some investors and Institutions won't buy OTC's at any price.

I don't see Institutions buying on emotion, unless they're essentially computer traders who're buying, and selling, perhaps many times in the very same day. The Institutions that buy, and hold will come in when the price is stably trading at a few dollars or more, many not till $5 or even $7 is achieved. Many brokers won't allow margin trading on NWBO even at $5 or more instantly, but eventually it will gain that status, and some investors will use it to increase their holding as well. On more than one occasion Fidelity suddenly stopped permitting margin on IMGN after it made a major move up, this forced sales by some investors in spite of having far more equity than before the move. I don't like it when brokerages take such action, how can you say you allowed full margin when a share is $7 and no margin when the price is $20, but they do and in their own way they were holding the share price down by their actions. When brokers take such actions you can move to a different brokerage, but often they act together in this manner. I don't know if major Institutions use margin, but I suspect if they do they're not affected by the decisions of brokers the way individual investors are.

Frankly I expect that when we're stable at $5 or more and on a major exchange the company will conduct offerings priced slightly below the current trading price. The purpose is both funding the company, but also to meet a heavy demand by Institutional Investors who want to establish large positions which provide stability to the company. Even if the company doesn't need the funds at precisely that time, they'll still agree to do the offering that will go entirely to Institutional investors. Individual investors may not like this, but in the long run it's for the benefit of the company, and us investors. In time I'd also suspect they'll ask to raise the authorized shares, perhaps to as much as 3 billion shares, that would give them the flexibility to either take in an equity partner, or acquire a company, like Oncovir, for instance, in exchange for shares. Nothing like this should occur before $5 or more is seen, and we're on a major exchange, but in time I'd bet it will happen unless there is a buyout.

Gary

biosectinvestor,

Maybe the science overlap implications are why there is not much talk about the trials. No sense explaining the research implications for the competitors. Science always gets ahead of the curve, even with accidental discoveries like the polymer research at 3M that led to post-it notes. Best wishes.

It's nice to imagine, but reality is it's .38. It could be 2025 before we see $1. I hope not but so far there has only been disappointment and frustration. Our money has been parked in the deadzone for far too long now.

learningcurve2020,

I guess in your mind that makes Linda a one of a kind entrepreneur legend in that she not only gets two CDMOs up and running successfully but also the research company, NWBO, that protected its IP through the ownership and use of them. That must really get under the skin of those kings of pharma who will soon be known as having second rate treatments and hedge funds that thought they could just have their way with NWBO shareholders. They have been profits over patient progress focused and essentially non supporters of tech that they did not value correctly early on which now is going to turn them on their heads. This being caused by their short sightedness mixed in with a little to lots of arrogance perhaps.
Big pharmas and hedge fund supporters of same had a chance to see what many longs could see coming since at least 2014 and big pharma’s own research indicated was true. Alas, they chose their own course with NWBO continuing to limp along except for getting the final enrollment help from Mr. Neil Woodford who then cut off funding when costs of development and cash burn rates were reaching their highest rate and most favored nation status for NWBO financing arrangements was cut off. This made it impossible for Cognate to carry much of the financing needed as NWBO moved forward. Hence the dilution with so called vulture financing while the need for more automated manufacturing became glaringly apparent with regard to meeting demand for both GBM and rGBM with adequate reimbursement rates as well as for use in other trials.
So thanks again for reminding longs that we will be rewarded immensely precisely because the CEO of NWBO does things differently than those who go on to fail at a nearly 90% rate because she has a very high success rate with all the companies she has put together. Best wishes.

The manufacturing facilities inspections.

LP said they had not been scheduled yet a few weeks ago. They are part of the approval process.

The measure of the mutated adopted in the approved ADCs or ADCs currently in clinical trial can be found in the NCI analysis on the tissue samples from the p3 trial of NWBO.

I suspect the dendritic cell primed by NWBO technology can spot various types of mutated genes better than other current available technologies. Any BP which has franchise deal with NWBO can use DCVax-L to identify potential targets which can be used for their ADCs and t-cell engagers. Before DCVax-L, they may have to search a daimon in an ocean. With DCVax-L, they can search the diamond in a small pond. The writing on the wall is clear and obvious!



Glioblastoma Molecular Characteristics and Immune Microenvironment Associated with Survival Outcomes in Patients Treated with Dendritic Cell Vaccination
https://www.ncbi.nlm.nih.gov/geo/download/?acc=GSE249282&format=file&file=GSE249282%5FDC%5Fvaccine%5Ffiltered%5Fnormalized%5Fdata%2Etxt%2Egz

https://careers.astrazeneca.com/job/gaithersburg/senior-director-pathology-cancer-biomarker-development/7684/65859983152
https://careers.astrazeneca.com/job/gaithersburg/senior-medical-director-senior-director-early-clinical-research-early-r-and-i-clinical-development-/7684/63696583664
https://careers.astrazeneca.com/job/gaithersburg/senior-director-bioconjugation-biologics-engineering/7684/64592150192
https://careers.astrazeneca.com/job/gaithersburg/associate-principal-scientist-bioscience-immunology-early-respiratory-and-immunology/7684/67604658736
https://careers.astrazeneca.com/job/gothenburg/associate-principal-scientist-senior-scientist-bioinformatics-translational-science-and-experimenta/7684/67357091920

LOL!!!!

Why do you keep oscillating between "it's dead" and "still in process of being dead"?

Do you realize how ignorant you sound?

You are beyond being obsessed. Unfortunately you have become a stalker.

You truly need to seek medical help.


Life doesn't have to be so miserable. Your choice!!

Horse,

I am not sure there is patent encroachment.

But their results in no way can be compared with those from NWBO. Take a look at the poster. After over half a year, not many activated CD8 t cells can be seen.

The company must be in a hurry to publish the results. OS of three years is a critical threshold that fail so many promising treatments. Patients in Diakonos' trial haven't reached three years yet.

I also doubt if Diakonos is allowed to combine dendritic cell vaccine with pd-1 inhibitors since NWBO filed the patent on this regard.

https://clinicaltrials.gov/study/NCT04552886

https://www.diakonosoncology.com/wp-content/uploads/2024/04/DIAKONS_AACR-poster-2024-final.pdf

Gary - Well said. I have to feel very strongly in my gut, when I choose to make a large commitment. We can call it emotion, euphoria, or just a great story, that motivates people to buy-in. If the story is well told, and all the boxes checked at the right time, FOMO, combined with wanting to buy-in when prices appear undervalued as it rises, we could be looking at something really unexpected. Plus, with the MTD news, if positive, add an up-list with trailing PR's, like you said, anything is possible.

GLTU

What kind of inspection requirements? Tia

A win, or loss is based on approval. Precisely what day, week, month, or even year that approval occurs doesn't matter as long as it's an approval. If a company fails on one attempt, but still has other shots on goal it's only a failure if all it's shots fail. A shot can be defined almost any way you wish. Some companies have many different products in development, that's what IMGN did until first they gained approval on Kadcyla, but it's Roche's drug, but finally they gained approval on Elahere, which they developed and owned. I often put down CVM, for at least a few decades they've had one product, they keep trying that product against different targets, it keeps failing and they just turn around, select another target, and use a good search and replace program on all their prior press releases and insert their new target for the abandoned old one. Perhaps some day their cure will find it's disease and they'll have great success, meanwhile they do reverse splits and issue a lot of new shares along with PR's that are confident that this time their technology works on the newly selected disease. I will admit that I invested in it many years ago, it was called CVM even back then, but they used the symbol HIV, and of course the target back then was AIDS.

I believe our first full shot, DCVax-L, will be a winner and it won't be that long before we know it. I say full shot because I wasn't in the company at its genesis but believe they had others, like DCVax-Prostate and I'm not certain they didn't have it before DCVax-L, but it was the first they determined to take into pivotal trials, so it's their first real shot. I frankly don't know if in the future there is a place for DCVax-Prostate, of if DCVax-L and/or Direct will fill that role without a separate product being brought through trials.

I certainly believe the company will be developing, or acquiring new technology, as in their recent agreement. New products will either build on the success of the DCVax's, or perhaps improve on them, and ultimately replace them. Almost nothing is absolutely forever, but some products are good for over a century, like aspirin, while others last a decade or two before improvements lead to better versions that ultimately replace the earlier versions. A decade from now we might see improvements on the DCVax's by others, it won't matter, we'll be wealthy beyond our expectations far before then.

Gary

TTsr. How do you get past the inspections requirement that the CEO had not yet taken place?

Agreed Gary… this is the heaviest lift by a pre-rev biotech, EVER!

“18 months” Laughable… NWBO will have MHRA approval in weeks.

If it’s dead money you’re concerned about couldn’t you have gotten out then back in over a 13 year period???

Funny but whenever - and it doesn’t happen often - LP or Les even mentions ‘time’ it’s then written in stone by some! Les talked about being a different company by the ‘Fall’ so nothing + could possibly happen til then, or LP mentions 12-18 months, so nothing + for at least a year. Think what you want but I believe it’s close & gonna strike like lightning!

There is almost nothing a CEO can do to expedite what's demanded by the regulators to approve a therapeutic. In IMGN's case, the regulators could have approved Elahere years before they did, but they insisted that IMGN try the drug in a greater percentage of the patients than it was originally targeted at, when the trial proved that rather than approving the drug based on the benefits by those it was targeted at they said, there weren't enough of them, go run more trials. The did allow a smaller trials to reach an approval, but wanted a larger confirmational trial which eventually showed the same thing. By the time the confirmational trial was completed, the company had been sold for a low ball price IMHO.

In short, companies are at the mercy of the regulators, and the regulators are generally thought to favor the BP's over the tiny Biotech's. LP has done an amazing job getting the company to the brink of tremendous success. I believe we'll achieve that success well before she either sells, or retires from the company.

Gary

Sorry, never gamble, as the House always wins☝️🥴

So you think that Approval could be Thursday ! WOW