Haven’t posted or read for a while. Hope everyone is well in these difficult times. Not sure if this has been posted but I cried:
https://www.cnn.com/videos/us/2024/02/08/all-there-is-podcast-mother-loses-son-brain-cancer-ac360-contd-vpx.cnn

95%?
Northwest Biotherapeutics Inc
OTCMKTS: NWBO
0.51 USD -0.18 (-26.09%)past year
Aug 2, 4:00?PM EDT • Disclaimer
https://www.google.com/search?q=nwbo&rlz=1CDGOYI_enUS596US596&oq=nwbo&gs_lcrp=EgZjaHJvbWUyBggAEEUYOdIBCDI3MTFqMGo0qAIAsAIA&hl=en-US&sourceid=chrome-mobile&ie=UTF-8

Makes sense and I’d hope that this is what they are doing. It isn’t inconceivable that they would want to keep all of this a secret.

However it is nearly inconceivable to me that they would both keep it a secret and provide false information about a 1.7 million page application being nearly finalized and about PRing the submission of said application.

Maybe I just don’t understand the rolling review process and these statements make complete sense.

IMHO it’s more likely that it’s just taking a really long time with the MAA submission due to the complexity of the SAP, treatment, manufacturing, and of course the application itself.

Great post, thanks!

I hate to even think it but, I am fearful that nefarious parties, acting on the defendants behalf, will get to Honorable Judge Gorenstein in some way.

It’s not just the billion(s) of dollars that they’d have to pay to NWBO but it sets a precedent/paves the way for the thousands of other companies that have been harmed by these same practices.

We’re talking TRILLIONS of dollars in damages and the end of market makers as we know them. They are going to fight tooth and nail to keep NWBO from getting a judgment against them.

I think if the motion to dismiss is denied (as it obviously should be) we’ll see a major effort to settle and keep this case out of court.

It’s wild so see bears pivoting to the “argument” that even after UK APPROVAL the company is still worthless because management is just so horrible that they will botch commercialization

I actually agree with you that this management team shouldn’t go it alone for commercializations

How do you know that the milestone holding up a major buyout or partnership isn’t UK approval?

Even if there is no buyout or partnership in place, how do you know that the Company isn’t waiting on approval to approach partners to assist in commercializing at much more favorable terms?

Anyway arguing the same topic over and over is futile but it seems disingenuous to say that even if the treatment is approved the company is still a failure.

Great info but you can’t put quotes around written communication without identifying the source of the quote.

It sounds like something DI would say but what reason could there possibly be for quoting a written communication that is clearly from a company but then XXXXXing out the name of the person he’s quoting???

UK approval would change literally EVERYTHING for NWBO and make it EXPONENTIALLY harder (more expensive) for shorts to manipulate the price.
1. Everyone with GBM will immediately demand it.
2. Every medical professional will immediately demand it.
3. Every GBM organization will talk about it.
4. Every reputable news organization will cover it.
5. AF et. al Will immediately lose their most of their ability to cast doubt on approvals
6. The chances of FDA approval will go up exponentially (don’t believe anyone that tells you that they don’t care what the MHRA does).
7. GBM patients and advocates in the US will immediately create buzz about the lack of approval in the US (and elsewhere)
8. GBM patients with the financial means from all over the world to get treatment in the UK.
9. Every BP will take notice of the first new treatment for GBM in 20 years which just so happens to be extremely effective in combination with other treatments.
10. Revenues would be almost immediate and would be substantial even with just UK GBM patients alone.
11. Both the need for and the amount of dilution would be greatly reduced and even eliminate.
12. Short squeezes happen and if NWBO has 10% of the naked shorts that many estimate, the approval squeeze could be violent.
13. The risk of insolvency would be dramatically reduced.
14. The chances of uplifting would be immediately and exponentially increased.
15. Combo trials would immediately be in massive demand.
The list goes on and on!!!

Stayed private?

Thanks Chiugray, always read your posts, you’re a true supporter of dcvax. It will really be gratifying when everything finally comes together, especially for the OG’s like yourself Senti, Flipper, etc.

Oooooh I love that ;)

Right so like in purely theoretical medieval terms (from someone baked) it’s like if the evil “black knight” Sir Merck of Rahway is about to hostilely capture the beautiful princess Murcidencel of Sawston, but the slightly more handsome “white knight” Sir Bristol Myers of Squibb swoops in to “rescue her” and takes her away to come live with him under slightly more favorable terms to her mother Queen Linda Powers of Bethesda and her 50k faithful subjects???

Speaking of white knights, it sure would be nice to hear from our resident insider in shining armor Thermo… his certainty and regular posts that May and then June was THE month followed by silence for the last 5 weeks leads me to believe that either the MAA submission is imminent or that there is a delay, the reason for which he cannot risk disclosing even in Thermo code.

Well the good news is .50 is only a few pennies away.

First thank you for sharing. I 100% believe this to be authentic and am not shooting the messenger.

DI’s responses are contradictory, pathetic, whiny, defensive and self-victimizing. Basically he’s saying the company always fails to accomplish milestones within a reasonable timeframe, so the company has decided it will just stop communicating publicly with investors, which will excuse them from ever being accountable for anything.

Code for “it’s not our fault the share price is tanking” so “don’t expect us to do anything.”

Watching people that have been invested for less than a few years criticize a fellow bull who has been PATIENTLY investing, believing in, researching and providing quality DD in a company for over a DECADE is just gross. You can believe in management and still be critical of delays, lack of updates, and the resulting low share price (manipulation or not).

Edit: I do believe the price is heavily manipulated but the lack of any communication on RA filing progress when we are already in H2 2023 has hurt the share price. it is incomprehensible that they have nothing material to communicate at this point in time.

The term “White Night” has a very specific definition in the investment world:

GBM is a known as a TERMINAL BRAIN CANCER because it kills EVERYONE who gets it regardless of age, health, or gender, whether you’re a good person or a person who posts revolting comments on message boards.

IMO recent estate/tax planning has more to to with the expected large value of management’s shares IN THEIR LIFETIME and likely in the NEAR FUTURE than some secret evil plan to delay approval unnecessarily.

I agree in large part with this, but I don’t think the delays are simply the result of management not needing the money because they old and lazy and rich and don’t care and would rather leave it to their heirs ;)

IMO the delays have to do with multiple factors, not all of them nefarious. IMO this is the main factor:

Almost all of the delays in the trial and post data lock events relate directly to INCREASING the chances of regulatory approval (OS primary endpoint, external controls, adjudication/advancements in detection of pseudo progression, long tail survival data, waiting for updated RA guidance, manufacturing certifications, manufacturing improvements/cost saving, manufacturing buildout/scale, publication in a top tier journal, having thorough and well vetted regulatory applications, etc.)

In short, management is ensuring the treatment has the greatest chance of being approved at the expense of time.

While this certainly hurts the thousands of patients that die because treatment approval is delayed, the counter argument is that if they had rushed the process (eg applied for approval without external controls) there is a high chance that it would be rejected by all 4 RA’s and NOBODY would benefit.

It’s a cruel analysis that many long suffering shareholders are quick to dismiss because TRUST ME it hurts to be invested in a science that you believe in for years while you lose a massive chunk of your lifetime savings… but there really is no other explanation unless you think management is just collecting a salary/bonuses and building up/selling of CDMOs on the back of a GBM treatment the know will fail.

For me (once I see past my frustrations) the SAP, external controls, Flaskworks acquisition, TLD, MIA, PIP, filing in the UK first, and most of all publication in a top tier journal PROVE that management is doing everything it can (against significant impediments) get this novel biologic treatment to market.

Unfortunately due to a multitude of factors our perceptions of reasonable timelines, our investments, and most importantly GBM patients will suffer until that happens.

BTW I’m not giving management a pass at all. I just don’t buy in to the narrative that they are intentionally causing delays because they know the treatment doesn’t work and are simply delaying its inevitable rejection. Quit the contrary, the delays are exponentially increasing the chances of regulatory approval.

The whole point of a rolling review is to SPEED UP THE APPROVAL PROCESS, yet by some twisted logic you have found a way to BLAME NWBO for using the rolling review as a way to SLOW DOWN THE APPROVAL PROCESS lololololz

Thanks for clarifying. I feel the same on share price although we could easily hit .50 or below if we get no news and/or there is another coordinated short attack
That’s a good attitude on trading… perhaps I’ve been a bit hard on myself, not so much for missing the exact bottom, but more for not taking some profits on the day it gapped up and then hit .78

Thanks for sharing this yet again. Nearly every section of this guidance is extremely favorable to NWBO, except one, arguably inapplicable, sentence where it basically says that sponsors, prior to commencing a study using an ECA, SHOULD pre-specify the ECA protocol

Not only is this GUIDANCE a SHOULD vs a MUST but it is not applicable to the DCVAX-L trial because NWBO was ALREADY conducting a traditional double blind clinical trial when the FDA required LL to give all members of the control arm the opportunity to get the treatment, thereby eliminating the control arm.

The use of ECAs will be evaluated by the FDA on a case by case basis, and it would have been impossible for NWBO to select the external control arm protocol before the FDA itself eliminated the internal control arm several years into the double blind trial.

You are intentionally ignoring this FACT in your “analysis” that NWBO somehow failed to follow the hard and fast rules regarding ECAs that will result in the rejection of BLA. In reality this GUIDANCE is inapplicable in this situation and the FDA will almost certainly consider the fact that the FDA mandates crossover necessitated the external control arm.

100% agree.
Did you mean .63 ?

When I emailed him about texting an investor that they only plan on PRing MAA approval and NOT submission/acceptance he said:

“I do not believe I have indicated that”

BTW although I agree with you on this point, I do not agree with your assessment of the company.

FWIW I just reconfirmed with DI that they plan on PRing MAA submission and/or acceptance. Obviously this is not a binding statement on behalf of the company, but it seems more logical than keeping the entire regulatory approval process of a public agency secret. Have a good day all, hope the share price turns around soon.

100% agree that they should PR acceptance not submission, which is why I was shocked that he was so definitive about PRing submission. I was even more shocked to hear they do not plan on PRing either. Seems pretty unusual if that is the case, but I certainly realize that the company isn’t bound by DI’s statements.

That was a great acquisition and certainly a surprise but not related to meeting a timeline.

He told me exactly that in writing and about 10 others people on here as well.

I am very hopeful that MAA and other regulatory approvals will be in an accelerated basis, but that’s a lot different than somehow keeping the entire regulatory approval process itself secret.

Love you Hoff, but his point is that DI should REFRAIN from saying ANYTHING about matters he is not permitted to talk about.

Telling some people (myself included) that they will PR the MAA SUBMISSION, but then cryptically implying that they will NOT PR submission or acceptance but instead will only PR APPROVAL is BS.

Same with LG on the BigBiz Show, if the plan was to stay quiet until MAA submission or acceptance or even approval, then stay quiet. It’s hard enough to be patient without all the unprofessional garbage.

We’ve already done the “secret BLA approval” nonsense 2 years ago. I’d love for that to be true, but they have proven time and again that they will not surprise us with anything timeline-wise.

On the 6/16/23 show they have a “brought to you by Northwest Biotheraputics,” which leads me to believe WE are paying for it.

I feel your pain but it’s literally coming together in front of our eyes. Data Lock, TLD, Publication, Manufacturing Approval, Applications for Approval imminent, approvals in the next year.
I hope we all survive that long :)

I normally enjoy your posts but this one just seems like an attention grab.
1. The FACTS (actual data that forms the basis for a major lawsuit by a highly reputable firm on a contingency basis) dictate that the stock has been HEAVILY MANIPULATED; and
2. There is only one reason stocks are manipulated downward and that is because there are a significant amount of SHORTS.
Again the reason we’re at .57 is multi factorial but one of the major reasons is manipulation/shorts and another is massive delays and dilution.
BTW these factors are also related to each other.

There has been relatively little additional dilution vs warrants exercised since 2020. We knew there were about 1.4 billion fully diluted shares outstanding in early 2020 (public OS 600,000,000) and we know there are about 1.55 billion now (public OS 1,100,000).

I’ve had a similar thought but the market has a way of playing out differently than expected. We shall see…

Technically the dilution already occurred hence the term “fully diluted shares outstanding” which is roughly 1.5 billion. Almost every one of these additional outstanding shares represents the EXERCISE OF WARRANTS. BTW this also provides the company with cash of around $.25 per share. Anyway, not saying it’s a good thing to be adding shares to the float/public OS, but they’ve already been issued (some many years ago). It’s an interesting thought that the spoofing is somehow connected to the warrants. I guess in a way the existence of 400,000,000 additional unexercised warrants does give the naked shorts and spoofers ammo, since they know the warrant holders are going to be adding millions of shares to the float every month.

Agreed. While I’d love to see a forward looking statement about their specific plans/timelines for regulatory filings, Flaskworks approval, etc. even that would likely be used against them by shorts/manipulators. From what I’ve seen with the NVCR FUD army it could even jeopardize their chances of approval. Don’t get me wrong, this share price/daily manipulation totally sucks, but there is not much the company can do at this point that won’t come off like a pump PR, which would immediately get sold off.

Kind of like back in 2018-2020 when everyone gave up hope and said it would never go above .30 and then suddenly it ran18X or 1,692% from $.14 to $2.51 on data lock, sap revisions, and FlaskWorks acquisition?

NWBO is being manipulated just like it was when they drove it down to 14 cents. Getting retail to give up hope is the whole point of manipulation. The fact that so many people are saying things like “nothing will make NWBO go up” is actually a great sign.

You may be right that MAA acceptance won’t cause any significant price appreciation, but unless DCVAX fails to gain approval, there WILL be a violent squeeze/FOMO event at some point in the not too distant future (likely triggered by an event like approval, revenues, partnership, lawsuit settlement, uplisting etc.).

Just an observation, not an assault.

Downright giddy this morning aren’t we?