I can't believe you're still pulling this nonsense every day. Get a freaking LEGIT job doing something beneficial for society. For heaven's sake.

ATL-DC = DCVax-L

What is the title of this article? https://jamanetwork.com/journals/jamaoncology/fullarticle/2798847

Association of Autologous Tumor Lysate-Loaded Dendritic Cell Vaccination With Extension of Survival Among Patients With Newly Diagnosed and Recurrent Glioblastoma A Phase 3 Prospective Externally Controlled Cohort Trial

What trial is that? DCVax-L = Autologous Tumor Lysate-Loaded Dendritic Cell Vaccination = ATL-DC

They don't start from scratch with every trial. Each trial builds on the next. That's just how it works. You may not WANT to believe it for the purposes of your deceitful postings on the internet, but that's actually how SCIENCE and MEDICAL RESEARCH work. They did not invent some new vaccine just to annoy everyone in the world and start over again. Dr. Liau would need to live at least 250 years if she or the team operated in the manner that you suggest. They'd have to be trees or more likely Ents, from Middle Earth. The ridiculousness of these posts. I leave for a time just to be away from this nonsense and I come back and the same nonsense is still going on.

https://investorshub.advfn.com/boards/read_msg.aspx?message_id=172127616

https://investorshub.advfn.com/boards/read_msg.aspx?message_id=172944119

https://investorshub.advfn.com/boards/read_msg.aspx?message_id=171955408

https://investorshub.advfn.com/boards/read_msg.aspx?message_id=172987041

Also, direct from UCLA Health's PRESS OFFICE, OFFICIAL - THey don't LIE in these things, by the way. They are very careful. You'd have to be an idiot to keep repeating this nonsense and ignore all the indicators. But people get wealthy relying on the idiocy of the markets, no doubt.

https://www.uclahealth.org/news/fda-approval-brain-cancer-alzheimers

THE VACCINE... THE SAME VACCINE... there is zero ambiguity here. NONE. NADA. Zilch... There is no other dendritic cell vaccine being tested by Dr. Liau with a PD-1 checkpoint inhibitor, and that trial includes poly-iclc. No ambiguity but that which is invented by anonymous posters on the internet.

Ah; you're just talking off label for an already approved oncology drug.

You seem to forget that the 21st Century Cures Act is all about making those drugs not just broadly available to a broader array of patients and conditions asap, but also getting insurance coverage even if the drug is not officially approved yet. That's a whole other more complicated conversation but basically you're talking like it's the 1970s... and it's not, by th me way.

This is not true. Too many people I know go for experimental treatments overseas including people I know really can't afford it but somehow get the money together and most of those treatments are untried and a waste of money. I have known too many people who, being diagnosed with serious, life threatening cancer, have done this, in actual fact. 

So do I think it's unlikely if you have a validated treatment that will likely also be approved here and that doctors at top research institutions recommend here, that people 1) would not hear if it; and 2) that some number would not seek to get that treatment? Is it the masses that everyone would hope for, no. It's off-label. Yes, it's out of pocket and it's not for everyone to do that, or to find the resources to do it. It would be a limited part of that patient population.  But not everyone is without resources in the families or more broadly including friends and family. 

A lot of those deals go bad or don't ultimately pan out.

And the fact is, there has been so much misinformation and noise around a treatment that has never had a similar exact treatment approved before, as this is entirely personalized, so it would probably be controversial for a CEO at a BP to sign-up for the kinds of dollars that this could potentially command if it were approved, prior to approval.

So it's likely, until that approval, they won't have offers they can reasonably consider, if executives believe, as it seems surely that they do, that this is headed not just for approval, but for blockbuster status eventually. This is not an area swarmed by the entire field of Oncology. Most are focused on RNA Vaccines and TTF, even though TTF is not really a likely super solution, it is approved and has no industry trying to disturb it, and it generates a sizable income for practitioners in the field who clearly do not want to see that income disturbed by some sort of easy to administer, doctor office given, no side-effects giving treatment that leaves substantially less money on the table for the clinic and doctors to partake in. And for RNA vaccines, you have big Pharma and they are going to doll out cash to get to approval to anyone looking to partake. NWBO doesn't have that kind of money. So established players with interests to protect are going to be very hostile. No big Pharma wants to walk into that, with a substantial offer of cash and support, without an approval of some sort. But that dynamic, I believe and expect will change when they have at least one approval and hopefully multiple approvals ultimately.

Anticipating yeah, but the instruction talks about contracts being subject to conditions still being "materially definitive"... Yes, but most materially definitive contracts have conditionality.  But some contracts are wholly conditional and that condition is based on events that are uncertain, and that neither party fully controls, such as a regulatory approval or even financing. 

To explain the difference between a contract that is subject to conditions and one that is wholly conditional on a future event like regulatory drug approval, we need to consider the nature of the agreement’s enforceability and its implications for disclosure under Form 8-K Item 

1.01. Here’s the breakdown:

1. Contracts Subject to Conditions

• Definition: These contracts are immediately binding and enforceable, even if certain conditions must be met before the parties are obligated to perform some or all of their duties.

• Key Point: The contract itself exists as a definitive agreement, with conditional terms specifying how obligations or rights are triggered.

• Disclosure Obligation:

• Such agreements are considered material definitive agreements under Item 1.01 because they are enforceable.

• For example: A licensing contract might require certain milestones (e.g., submission of clinical trial data) before payments or rights transfer, but the contract is enforceable upon signing.

2. Contracts Wholly Conditional on a Future Event

• Definition: These contracts are not enforceable at the time of signing and only take effect if a specific, uncertain event occurs in the future.

• Key Point: Until the condition occurs, the agreement does not create enforceable rights or obligations.

• Disclosure Obligation:

• Such agreements are not considered material definitive agreements under Item 1.01 because they lack enforceability.

• For example: A contract stating that a company will acquire rights to a drug only if regulatory approval is granted does not need disclosure until the approval occurs and the agreement becomes binding.

Practical Examples:

Contract Subject to Conditions:

• A company signs a sales agreement requiring manufacturing quality certification before shipment.

• The agreement is enforceable immediately, but the conditions define when performance begins.

Contract Wholly Conditional on Future Events:

• A company enters into a contract that only becomes binding if and when the FDA approves a drug.

• Since the entire enforceability hinges on an uncertain event, it does not meet Item 1.01 disclosure requirements until the event occurs.

Why the Difference Matters:

Under Item 1.01(b), a material definitive agreement is defined as one that provides material, enforceable obligations or rights, even if subject to conditions.

If the contract’s enforceability depends entirely on a future event, it is not a definitive agreement and disclosure is not required under 8-K or other disclosure rules. 

Contingent liabilities can be generally disclosed in financial statements. That is not the same kind of disclosure however. It does not require that all of their derivative trading contracts and all of the precise derails or similar issues need to be disclosed in precise detail, for instance,if there is some potential for contingent liability. The company has discussed some contingent things that may benefit investors in their financial report and that is all they likely need to do for the time being.

You continue to mislead people:

https://investorshub.advfn.com/boards/read_msg.aspx?message_id=175397704

False. The MHRA does not have immense experience approving any products like DCVax-L, which is a personalized biologic unlike anything else currently in the market. It's not just autologous, the process then uses tumor tissue from the patient to literally program immune cells also from that patient. It no doubt requires spare resources to be used and possibly external resources to be engaged to do the appropriate analysis and approval. So no, it is not because it is a poorly formed application, but likely because it does require expertise that is not common in approvals of typical drugs or even typical biological compounds and products. 

MHRA has said as much previously though I do not have my hands on the statement.

A contingent agreement is definitely not 8-K material. I just posted on this. That is false. You do disclose in financial disclosures that you may have contingent liabilities or assets but the contract itself is not materially definitive in this context, and those contracts are not subject to full disclosure, as some who misinform people here suggest.

Material Definitve Agreements:

The disclosure obligation applies only when an agreement is definitive and material. If an agreement is wholly conditional upon future events that may not occur, it generally does not require disclosure until those conditions are met.

Form 8-K, Item 1.01, states:

“Item 1.01 Entry into a Material Definitive Agreement.

(a) If the registrant has entered into a material definitive agreement not made in the ordinary course of business of the registrant, or into any amendment of such agreement that is material to the registrant, disclose the following information:

(1) the date on which the agreement was entered into or amended, the identity of the parties to the agreement or amendment and a brief description of any material relationship between the registrant or its affiliates and any of the parties, other than in respect of the material definitive agreement or amendment; and

(2) a brief description of the terms and conditions of the agreement or amendment that are material to the registrant.

(b) For purposes of this Item 1.01, a material definitive agreement means an agreement that provides for obligations that are material to and enforceable against the registrant, or rights that are material to the registrant and enforceable by the registrant against one or more other parties to the agreement, in each case whether or not subject to conditions.”

Key takeaway: If the agreement’s enforceability depends entirely on future events, it is not considered a material definitive agreement under Item 1.01 until those conditions are met.

https://www.sec.gov/files/form8-k.pdf

Their factory is in the UK, AND the UK has spent years trying to attract and groom the company to be a successful UK company. The award they got from the UK government as the first such award, and allowing them to sell at full price to their citizens even before approval, suggests a very favorable environment that doesn't exist even for those companies you mention in the US. Yes, the US is a bigger market but the two regulators are perceived to have similarly high standards, and so of course they would continue with the regulator that is making it as easy as possible to take it to approval. Being able to provide DCVax-L on a compassionate basis and recoup their exense for manufacturing it is amazing, even if it's still challenging because they cannot actually market it and don't yet have the full validation of an approval, which we hoe they will have soon.

https://www.gov.uk/government/news/first-uk-promising-innovative-medicine-designation-awarded


Advancing potential brain cancer treatments in the UK is a national priority. That's not the case in the US. I mean, FDA just doesn't have such a specific mandate. So between the enthusiasm over these years, and the efforts of the UK to help them, despite shorts nonsense, there would be a god reason for them to pursue approval there.

But yeah, investors defending their investment from arsonists posing as "helpers", with undisclosed interests, are not "pumpers". People posting here chatting amongst themselves as investors, are not shouting to the world, they are discussing amongst ourselves. Shorts with undisclosed interests try to disrupt and prevent newly interested potential investors from being interested by disrupting this site, and ensuring no one can read anything but negativity on sites like Yahoo and other similar, broader reach sites. And event hose that do, that's totally reasonable because they disclose their interests. Bashers like you pretend all kinds of things.... but no one believes you. You might as well be a criminal.

I am so sorry for your loss Mike. Prayers for your Uncle.

It can't be marketed, it doesn't make doctors wealthy like the helmet, it is only compassionate use and requires a large out of pocket, up front investment. So that narrative that it is already available and there is no market for it... is premature and not an accurate read for an approved drug, that can be marketed and where, and this is important, word has gotten out, because it still won't be possible to market it in other countries. 

Approval will be a major game changer because it means it is likely approvable in these other markets however, and that should open up more opportunities for company collaboration with other potential partners, probably accelerate discussions on deals and make things a lot easier at least when they have a reasonable revenue stream. The UK is closer to Europe, but you don't see a lot of medical tourism to the UK historically. But could happen. Just not a common thing. 

I do expect, if the UK approved and given previous German favorability, you could see an approval from the EMA as highly likely. I also think it will be highly influential on the FDA to accelerate their efforts to get this to market in the U.S.

Makes sense. Plus these are private patients paying for their treatment.

You keep changing your narrative about me. But yes, I do reply and no, mostly I point out how factually wrong you and others are…. I spend very little time apologizing for anyone, though telling the story flatly as negatively as possible is not, in my view true, in a substantive way, though some details are sometimes real, it’s the total picture that informs, not the partial one with both truth and exaggeration, and false implications.

And obviously that is my view. Like I said, I disclose my interest at the bottom of every post. You don’t.

My post explains it, you’re just here to state the short case. But go ahead. No one is stopping you. You’ve been posting this for years now.

No, I popped in briefly and can post quickly in response to idiocy. The long last post was chatGPT. Took about 5 minutes. You were there posting all weekend and on a holiday, without disclosing yours or the other shorts disclosing their true interests. Just nonstop bunk. I own the shares, this is an obscure board for NWBO investors to discuss their investment. Most longs disclose their position and post consistently with their economic interests, as disclosed.

And yet it’s not.

I simply saw an alert and replied. You posted all weekend and first thing again. Besides, I’m a l king and disclose my position always. You don’t.

And here you are first thing.

As an extra little bit here for you shorties, because you like to focus on the insignificant results for PFS, even though those are not usable for a number of very obvious and clear reasons...

I bring your attention to the JAMA Oncology paper, https://jamanetwork.com/journals/jamaoncology/fullarticle/2798847

I asked ChatGPT, after giving it the paper and supporting supplementary materials, about the difference in significance for survival OS and PFS measures. I had already seen the connection, but I wanted a comprehensive answer that I could easily post before sleep... Other than highlights, boldening or underlining, the ChatGPT answer is unedited.




Here is another answer I elicited earlier to discuss the issue of PFS and why it would be not significant. This is a point shorts constantly raise, but the reality is different than they suggest. The reality is, that difference was stated as not statistically significant. So pinning their argument on a statistically insignificant anomaly is completely insincere. But maybe they just did not read the study carefully enough or they don't understand statistical significance as a concept? Or maybe they don't care about the truth...

It is complete and addresses everything and you are still here posting your tell after tell after tell… proving just how worried you are.

I am comfortable and confident, but arsonists annoy me.

You keep days ng it vaguely while pretending you’re being “specific”… because you know they actually did address all the issues. But if you say what you mean, then it will be thoroughly rebutted. So you repeat and repeat your fake nonsense in as vague a way possible while pretending to reference a page here or there, as if you’re saying something.

Say what you mean.

I've reviewed the SAP (Statistical Analysis Plan) extensively, and it's clear that the trial fully addresses multiple secondary endpoints in accordance with rigorous scientific and statistical protocols. Some secondary endpoints may not have been as highlighted to your satisfaction in the publicly available results or presentations, but it's all there.

The SAP includes not only overall survival (OS) and progression-free survival (PFS) but also endpoints like confirmed PFS (cPFS), post-progression OS, time to progression, tumor response, immunostimulatory response, and more. These endpoints are part of a thorough and robust analytical framework, with predefined statistical methods laid out clearly in the 57-page SAP, as per standard practices. The analysis includes comparisons both within the trial and against carefully matched external control populations, which were vetted through independent expert consultation (York Health Economics Consortium, UK).

Of course there are some measures that were affected by both crossover, eliminating the internal placebo arm as well as pseudoprogression. These details are discussed in the report.

Furthermore, sensitivity analyses and adjustments for patient characteristics were performed to ensure the robustness of the findings. The methodology and approach to these endpoints, including adjustments for pseudo-progression, were outlined well in the SAP, which ensures that all relevant data points were considered properly.

It’s not about "bs-ing" anyone. The fact is, a lot of this data is complex and presented in scientific formats that sometimes don’t make it to headline presentations or simplified public discussions. However, that doesn’t mean the data isn’t there or that the endpoints have been ignored.

Let’s be clear—this was a carefully designed and executed trial. That is obvious from the analysis and all of the facts. Your complaints are your opinion, but they mislead.

For our friends pleading ignorance.... https://jamanetwork.com/journals/jamaoncology/fullarticle/2798847

I am so sorry for your loss. Prayers for your uncle and your family in this time of loss.

Still working? It’s your tell.

No, you guys are the ones who don’t have the facts. I am just not here to convince you or anyone else to invest in the heat of pointing out your tell. Your nonstop harassment, and those of your short compatriots, has no disclosed true reasonable rhyme or reason but that you’re swing traders or shorts. The swings are quite large for these small companies and traders do believe they can get quite better percentage returns whipsawing these tiny companies and I see you all as desperate.

Nowhere have I written that you should invest or want you to invest. I just point out that you say false things and post nonstop attacks that indicate how desperate you are, and what a tell that is… I do not spend my time here praising the glory of management or begging anyone to invest… but your lot spend all of your time harassing investors, which is pretty ugly.

This board would be a sleepy nothing but for all of you shorts’ activities here. I guess that is your job security with your masters, pretending there are so many here you guys have to post nonstop… you guys have quite a scam going with your employers.

What an ugly, pointless job.

I am not going to bother to extract it from either the JAMA publication or the multiple presentations first by Dr. Mulholland and then by Dr. Ashkan.

Some of the things you ask for you know actually are not there not because they never published or announced the endpoints but because you refuse to accept the updated SAP to regulators and this is your only refuge. It was updated before unblinding, created by an outside firm that was entirely blind to all results including interim, and the regulator specifically has indicated that they are open to such external arms, and the company made very clear, very real efforts to avoid bias or other issues that might come up because the update happened later.

As to other issues, those are issues for the regulators, but if we look at many of the other approved treatments and trials, they were far worse with no survival benefit, were sometimes reassessed after failure and approved.

Efforts by shorts to suggest there was some magical “cheat” that allowed for so many to survive so long, in a situation where survival is just not something that happens randomly, and statistically the further analysis by the external epidemiology form from University of Chicago, showed also how conclusive the data is…I believe will inevitably fail to give shorts the result they want so desperately and badly.

As for the placebo arm you pretend existed, it didn’t. It was a crossover trial, almost all the patients opted to cross over because of the perceived survival benefits. So it was depleted and such date was a mathematical
Impossibility, driven by an ethical, practical and ultimately FDA compulsion to give all of these patients access to the drug.

But yeah, you can pretend to ignore that reality, the impression of patients and doctors that people were surviving and the crossover aspect and keep claiming there is something “missing” that is somehow bad faith or whatever you seem so desperately to want to imply by not actually fully stating the question and leaving your intentionally malformed questions to ignorant speculation.

They release their quarterly reports. If anyone read your posts, they've never released any such things. As for quarterlies, it is a single-product development company at this stage. They report when there is something worth reporting. If you do not understand that you should not be even vaguely interested in this company or treatment and should be busy posting away about companies you like. But here you also are, on a holiday, on a holiday weekend, posting away like a maniac about a supposedly irrelevant, single product company that doesn't have quarterly calls? If they're so irrelevant, why are you so busy? Why do you dedicate what I can only imagine, after all of these years, 24-7-365, even if you were making a working man's wage, would be hundreds of thousands of dollars of time. But since you clearly are more sophisticated than that, someone must be paying a s/it load of money to have all you arsonists here all the time.... or you must be profiting a huge amount from these activities. Hard to know. I own the stock. I've been up a huge amount and sometimes down, mostly up. If you can believe it, I'm even now, still up on this stock. But you guys must be making a lot of money manipulating this up and down.

I'm not here to convince you or feed you information. Find whatever it is you're asking for, yourself. I don't help arsonists.

You've never pointed out other companies when I've asked you that were comparable, nor do I care what other companies you want to point out random companies with claims they are "better". I just suggested you invest in those companies. Not sure why you sit here harassing those of us invested here other than that you're a short.

I respect the science and doctors as well, but I also recognize who owns what and the potential of the science, medicine and the results of the clinical trials and side trials.

I do think management has a lot of a/holes trying to take this away from them by denigrating them and pretending they are here for us longs. The results of this kind of bashing is that people try to drive companies into bankruptcy so they can steal assets, and quite frankly, I think that's the game here. When people have assets that could either disrupt an industry or be very valuable, you get people like those who give the major TELL that all they do is bash.

I don't spend my time defending the company. I go after bashers. And bashers don't like that and pretend that I'm "defending management" because that's all you've got. The reality is, I see you as arsonists. And I don't like arsonists.

As for the company getting the trial to a successful end, getting permission to use an external control arm and getting it to this point, yeah, I don't think the bashers that chatter about have any idea what that entails and if they had it their way, in fact, the company and dcvax-L would be nowhere near where it is now. So if you want to say that is defending, you can claim that's what it is, but I think rather, I'm just pulling for a cure for cancer and I think this is going to be a great part of a larger solution. Bashing management is not going to accelerate that process, its only purpose is to undermine. And here you are, on a holiday weekend, bashing away non-stop. THAT IS A TELL. What are you scared of at this critical juncture when approval might be any day?

NWBO has quarterly updates and on time. But if you invest on Pinks, that is a quality of pinks. This is NOT a pink and if it did as you say, it would literally not be listed where it is and would be on the old pink sheets.

I’m not here to educate you and I am not here to justify them to you. My advice to you was to move on to a company you like, rather than claiming you’re a long for years and posting, whether they have meetings or not, for your negativity it matters not.

As for their last year meeting delay, I explained what I thought was likely. And yeah, this company has, in my opinion, had to deal with a lot more insanity from shorts than most, so I’m here because I like the science and because the insanity of short posting 24-7-365, holidays and weekends is a tell. So yeah, I don’t evaluate my investments based on anonymous posters and you should not either.

What I would suggest though, is that given your eternal, never ending negativity, you probably would be better off and happier concentrating on the companies you do like and not spending so much time and energy, Olympic level, posting negativity, when clearly, according to you, it is doing YOU no good. And personally, I feel like I know what I am in, I recognize the risk of total loss, which yeah, is there for the companies that are constantly posting PR’s and do all of the superficial stuff decently as well. My evaluation of my risk and tolerance for it is different than yours.

As for responding to your posts here that were to me, I really have no choice. But I also don’t appreciate shorts or swing traders burning down my investments for their short-term profits. Makes my a bit annoyed. I think that is entirely understandable and if you don’t get it, again, maybe you need to focus on the investments that meet your expectations and leave this one to the big boys…

Agreed. It is and has been a wild technological ride and it seems like we are in a whole new rapid trajectory. Big changes ahead.

I am praying so but biotech is still often slow, especially these days. But I believe DCVax-L will create a new and powerful modality and you’re correct that the most explosive way forward will be opportunities to collaborate with larger, established companies to provide new combinations and treatments. It’s a very exciting time to watch all the progress, everywhere, oncology, AI, robotics, broad biotech, everywhere. It will be an interesting decade ahead and in terms of technology.

This is a development stage company not yet commercial, and yes, I acknowledged it was late. I believe they delayed so they would have a lot of progress to report. It’s a single product development company at this stage, so there will inevitably be times when, despite immense work, there is not a lot to discuss. They understand with shorts working bulletin boards feverishly, having an ASM under such circumstances would be fodder for abuse and price manipulation, so yeah, they delayed. They filed their financial reports on time. Therefore all that was really required was a status report and reelection of board members, which they did on time, it was not something that bothered me. But since you do complain a lot, I don’t think such a pre-commercial,early stage microcap biotech is likely ideal for most investors. There are many stocks and companies in the world, find something that is more what you are used to and that addresses your comfort level better.

When it is licensed for marketing, better deals can be done. But also, extending labels no longer requires full trials. So that will be the biggest change and opportunity going forward, I believe. Real world evidence can be utilized. Trials will be for marketing. I think they will still do them, and then trials are about published, peer reviewed research and validation.

Makes complete sense.

They have been consistent, just the last one was particularly late. We’ll see.

All endpoints and trial results have been shared. There are no secrets.

Don’t be ridiculous repeating this lie. PFS was about pseudoprogression and they switched adopted OS by letting the trial run a very long time. Your claim that they did not better than the 9 placebo is bogus because given the crossover, there is no way to make such a claim.

This is why they used an external control arm, with concurrent major trials for the same disease, the top trials, with the same exact placebo, with blinded statisticians doing the set-up and further additional statistical analysis far beyond the norm to show that this was a valid measure.

You’re living in your own fantasy world. The fact is, virtually every other trial in this disease where a drug is currently licensed had profound issues. But NONE showed a survival benefit and this trial most certainly did. Quit pretending otherwise.

I don’t care. All I know is your s/it talking at me… which means you’re not really accomplishing your goals… and I am amused by that. Easily distracted by criticism… something to note.

Hey, I am not here 24-7-365 bashing, for years on end. You are… but yes, I can dish out rapid response posts… it’s easy for me. And you can’t even get your message out.