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They've been sitting on game-changing results for six years just waiting for GBM Day 2021! That's got to be it. This is so huge!
Can't wait to see what kind of "new and emerging" technology this 15-year-old trial produces!
If people were only aware of all the "accumulated positives" over any given eight month period in the preceding 15 years, they would say, gee, this sounds like the same hype machine we've seen many times before!
It's funny. Those without the benefit of experience tend to see everything as new and exciting - "emerging" if you will - when in reality there's nothing new under the sun. It takes going through these cycles a few times before one learns the stark and stoic rationality of the jaded cynic. This is your first time (how exciting!), so you should enjoy yourself. Your exuberance is understandable, and in a way I'm kind of jealous of that kind of naive bliss. It's charming. But remember the cruel world awaits. You will learn . . . eventually. NWBO rips your heart out every time.
Eventually, you and others will learn that it's not about DCVax at all. It's not about providing relief for a horrible disease. Unfortunately, what it's really all about is the people running this company. Always has been.
They could have released TLD last September, as they said they were going to do, but didn't because there was a setback. They were ready enough and prepared enough that they felt confident to put in writing that they planned to release TLD last September. So what possibly could have happened that we are now sitting here nine months later without TLD and no indication that we are any closer to TLD than we have ever been?
We can say with some certainty that whatever happened it wasn't good, because the only thing that can cause is a delay is bad news. In the absence of bad news, you go forward with your plans. That's common sense.
COVID-related issues do not satisfy me as an excuse, as I just can't see any reason why COVID issues would put off a planned September 2020 release for nine, 10, or 11 months, or who knows how long we are going to wait. COVID could certainly have caused a short delay, but to be waiting this long? I don't buy it. It seems more reasonable that they got a message from somebody, most likely the DMC, telling them to hold off. But why? What could the DMC have found in their review that would lead them to tell the company it would be best to delay releasing TLD?
Or, perhaps they are now waiting on some external event out of their control. Many here have speculated they are waiting for a publication, but I don't buy that reasoning either. There is no reason to wait for a publication to release TLD. None. So maybe they are waiting for something else to happen. But what could that be? Are they waiting for the FDA to give them some direction? Perhaps. But if that is the case, then why did they tell us they would release TLD last September when, presumably, they didn't have FDA guidance either?
Is it possible they are waiting for this? Promising Pathway Act
What if they got a message from the DMC that the data is mediocre at best? What would you do then if you were the CEO? Wouldn't you start looking at every alternative option for approval, anything that would salvage a 15-year trial, and might that include the Promising Pathway Act? Hmm. Just a guess, but honestly, it makes as much sense as anything else.
As I said, I would be more inclined to believe this is the reason for the perpetual delay, as opposed to the nonsense about publications and buyouts. But why can't they just tell us that?
They didn't just change the endpoints because they suddenly had some psychedelic epiphany on a baseball diamond in the middle of a cornfield. "Change the endpoints, Linda, and people will come . . ."
Is this what they are waiting for? Promising Pathway Act
Honestly, this is something I would be more inclined to believe over all the nonsense theories posted here about publications, buyouts and whatnot. But if so, once again, why don't they just tell us?
FYI, the bill was introduced more than a year ago and is still in committee. We could be here a while.
I'm sorry, when do you think they made the endpoint change? The web site was changed within a couple of months of data lock if I recall, which hardly makes "five minutes" hyperbolic in the scale of a 15-year trial. The point is, they changed the endpoints post facto after they knew what they had in hand. That's not cool.
I mean, of course they did it in the best interest of patients. They knew the trial would fail if they did nothing, so they had to do something. I think that is what everyone is slowly coming to agreement on, whereas before no one here was willing to even remotely acknowledge any kind of potential for any kind of failure at all, not even on one endpoint.
We are slowly and steadily getting to the point where people are finally going to understand the company has known for six years that this trial failed, never said anything about it to shareholders, and instead tried a last-minute switcheroo on the endpoints in a desperate move to salvage something, anything, at all.
Why hasn't the company been honest with shareholders?
It obviously requires at least seven degrees to formulate an answer to question: Why did they change the endpoints?
iwasadiver, since your question to me was deleted, I am creating this new post to answer your question. Again, people make assumptions and think they have all the answers and say things like, "You must be lying about holding shares of a company you think is a scam . . ."
No, actually I am not lying, and no, it becomes more and more clear that those people don't have all the answers. That's because there's nothing irrational about owning shares of a stock whose price you think is going to increase in the short term.
It's funny how everyone wants to make assumptions about me and yet they are always wrong. The irony there is that I've been completely honest and transparent about my position all along, and I have explained why I believe what I do over and over again. It's all there, so you can keep making assumptions if you want, or you can learn. I did average down, and I did take advantage of that 10-times gain by selling some a while back. But I still hold a good bit and I plan to hang on to it until the bitter end.
I have not lost a lot of money here. That was a secondary concern for me a couple of years ago, but losing money in this stock is not a concern for me at all anymore. My concern is that I strongly sense this company is essentially a scam and has been for six years because that's when they first learned this trial failed and instead of telling shareholders decided to cover it up and keep going in a whole new direction, raising tens of millions of dollars along the way, all while knowing there would be no end for this trial. My concern is that the people running this company have been lying to shareholders for six years. I find that kind of behavior reprehensible, unethical, and contrary to everything I have been taught and believe in and I will call it out wherever I see it as long as I have to until it is exposed. I do not believe this company has been honest with shareholders, both by commission and omission, and I will say it every day on this message board until everyone understands the truth.
Patients are not winning with this treatment because they've been holding on to this data for years. You don't behave that way when you have extraordinary, game-changing, lifesaving data. Don't you see that? They don't want to release it. That's where we are.
I don't know anything about Keytruda since I am not invested in it. I am, however, still invested in NWBO.
Go back and look at my posts from when I joined iHub. Back then I sounded exactly like you. The 2017 ASM is what turned me, and everything that has occurred since has validated that turn. The same will happen to you. Maybe not now, maybe not next week or even this year, but it will happen. Once you've been through enough of these cycles, once you have been lied to one too many times, you will begin to understand.
Sukus, it's fine if you want to believe in the Flaskworks unicorn. That's OK with me. I hope that believing in Flaskworks brings you great comfort and satisfaction.
BTW, how many pings did you get today? I haven't gotten any.
You are correct that a lot of people have thrown out a lot of reasons for why they refuse to release the data. There are dozens of them, ranging from "just a little company fighting an uphill battle", to "waiting on the FDA", to "waiting on a publication", to "they can't release the data because of COVID". And there are many more. The problem is, they are all lies.
The reason they refuse to release the data is the data itself, but no one here wants to acknowledge that little obvious fact. You haven't been here long enough to understand the perpetual cycle, but eventually you will catch on. Eventually you will come to understand when you are being lied to.
To all of you buyout prognosticators, why would anyone buy NWBO now when a little over a year ago they could have bought NWBO for about .17 a share? Seriously, what is your answer to that question? Do you think the people who run M&A for these mega-trillion big pharmas are stupid? Do you not think they knew all they needed to know about DCVax years ago? The question is, why didn't they act then? Hmm.
Pretty soon they're going to have to do something to make next month's payroll.
In the end, some of us will wonder just how much all of these years of delay cost in real dollars. How much did it cost them to "cross all the Ts and dot all the Is"? How many tens of millions did it cost to ensure this was "done the right way" and "not take any chances" on their way to "burning the shorts"? It would seem that the cost has been extraordinary in dollars, and worse, in lives when you factor in all the people lost to GBM in the interim.
You'd think if they had something good they'd have released it by now. Funny that they are still refusing to share TLD.
Not sure the purpose of posting this article except to expose the fraudulence of this process. The only rational response to reading this article from two years ago is to ask, "Well, then, why don't we have TLD?"
This article is nothing except more embarrassment. It is nothing except more credibility damage. It is nothing less than yet another indicator that something is very wrong.
Why is NWBO refusing to release TLD?
You haven't been here a year yet, so it's understandable that you are such a headstrong enthusiast. But give it time. You sound a lot like I did when I joined this board some years ago, a fierce defender of this poor little start-up biotech fighting the good fight against all the negative forces in the world. Like I said, totally understandable. But you, too, will eventually come around to understanding the truth of what is going on here. It may take another year, maybe two, before you start to understand that nothing this company promises ever happens. You will begin to see that all of the talk about this all-or-nothing Phase 3 trial is just a facade. You will start to wonder about what really happened back in 2015 when the whole direction of the trial suddenly changed with no explanation from the company.
People act as if the current expectation of imminent TLD is somehow different from all the previous TLD guarantees in years past. People say that this time we have data lock, so they have to release TLD soon. But I'm not so sure about that. In fact, I don't think what we are going through right now is any different from what we've gone through at least a half dozen times prior. And the end result is always the same. It's a game, and the company has played it very well. All of the company executives have made many millions of dollars over the years and have established extremely comfortable livings for themselves, all without doing a thing except asking for more money every few months and keeping the "imminent" expectation going.
Some people think that when it comes to human nature past behavior has no bearing on future results. I am not one of those people. I believe that past behavior is almost always the best indicator of what one can expect in the future. In the case of NWBO, we have been lied to too many times to count. We have been misled with grossly negligent comments. We have been aggressively diluted. And we have been the unwilling subjects of blatant incompetence over and over again. You seem like a pretty sharp person, so I am fairly confident that after some time you will begin to observe these trends and, like I did, start to wonder if maybe all of this hype about TLD is actually just a cover for something else. Because, you see, TLD never comes. Never. It didn't come any of the multiple times it was promised over the years going back to 2011, it didn't come in September 2020, and it's not coming any time soon.
At some point every one of us here has to ask themself a simple question: Why are they refusing to release the data?
NWBO has been an excellent investment for those who got in a year or so ago. For those of us who have been in a lot longer, well, not so much. And the disaster of the long-term investment remains almost entirely unexplained. Do you really think we'll ever get answers? Why did they promise TLD in September 2020 and then just abandon the plan with no explanation? What do you think happened that would cause them to not release TLD after promising in writing they would? That had to have been a momentous internal decision before the CEO made the ultimate call that, "No, we're not going to release TLD." There must have been some heated back and forth leading up to that decision knowing the egg-on-the-face and credibility damage that would result, and still, even after all that, to provide no explanation whatsoever to shareholders. Whatever happened, the one thing we know for sure is that it wasn't good.
FWIW, I don't believe the COVID excuse, and I don't believe anything this company says anymore. They are repugnant liars and the list of their transgressions is a mile long.
And you believe this? The question is, why do you believe it? They told us we would have TLD in September 2020 and failed to produce. Just ignored that they'd ever made such a promise. And then, seven months later, they tell us they can't produce TLD because of COVID-related issues. Were there no COVID-related issues when they promised TLD last September? Something doesn't add up. What changed, other than the fact that most COVID-related restrictions have been universally reduced since September 2020?
These excuses are old, tiresome, and it's the same old crap they've been spewing for years every time they make us think they are getting close to producing actual data. At what point are people going to finally say these excuses don't cut it anymore? There's always an excuse. Always. But there's never any data. The only consistency is their perpetual refusal to release TLD. So you can cite these convenient excuses all you want. The question is, why do you believe it?
See, here is the problem. You completely misidentify what most NWBO skeptics are saying. I'm not aware of anyone who has said NWBO is a "pump and dump" scheme. Why would anyone call a 16-year-old trial a pump and dump? Does that make any sense at all? No, it doesn't, so the fact is, you start your argument from a false premise.
I, and others, have speculated that NWBO from time to time has used certain public statements to pump the share price, usually right around the time of a cash raise, to allow lenders who have been paid in warrants an opportunity to quickly cash out at a nice short-term profit. The evidence is there, like it or not. Go back and look at statements made by the Investor Relations employee and the timing of those statements, especially his comment that an upcoming ASM would be so "interesting" we wouldn't want to miss it, and he and CEO encouraging shareholders to travel to the meeting from all over the world. These comments were highly unusual and, of course, the actual meeting presentation did not bear out any of the hype, while the comments led to a substantial share price rise coincidental with a cash raise. This has happened more than once.
But those were isolated incidents. Certainly NWBO's DCVax-L Phase 3 trial, taken as a whole, is not a pump and dump scheme. That's absurd. What it is, though, is a perpetual scheme that has created impressive wealth for many of the key figures at NWBO, and especially the CEO who has made in the hundreds of millions of dollars over the lifespan of this trial (which includes my estimate of the proceeds from the sale of Cognate, which recently resold for more than $880 million).
The principals of NWBO have figured out how to make a very nice living by keeping this trial going in perpetuity. They pay themselves nicely and have all made millions and millions of dollars. Why rush Sawston? Because it's another Cognate that will lead to great wealth for the CEO regardless of whether DCVax-L is part of the production line or not. Flaskworks? That's pure cover. They paid next to nothing for that device. Maybe some years from now it will help them produce DCVax if/when it is ever approved for some limited use. Who knows? But look at what they paid for it. Doesn't that tell you anything?
NWBO is not a pump and dump, but it has been a means to a nice living for many of the key figures at NWBO. Would you deny that? And would you deny that a nice living is a sufficient incentive to keep this trial going as long as possible? It sure looks that way, because to this day they continue to refuse to release TLD, even when they said in writing they would release it last September, and then claimed they didn't lock the data until early October. That is in addition to the dozens of other times they have misled us about imminent TLD over the history of this god-forsaken trial, all well-documented. You assume that approval in other countries is a given but your reasoning is flawed. The change of endpoints on a web site has no bearing on regulatory approval, and if that were the case then what are they waiting for? Why have they been waiting for five, six, even 10 or more years? Why are they still refusing to release the data? You can't just change the endpoints at the end of a 16-year trial and think everything will be hunky dory. That's not the way scientific study works. They have major, major problems with this trial. You know it, I know it, and everyone who has ever followed a bio-tech startup knows it. Not only that, but the people running this company have lied to us over and over again. Do you still trust people even after they lie to you? Why? Why would you believe people who lie to you, don't seem to care that they've lied to you, and provide no explanation for why they lied to you? This is a sham, and it's amazing that people can't see what is happening right in front of their eyes.
Some people would make excuses for this company even if NWBO were to request the IDs and passwords for shareholders' bank accounts. How hard is it to imagine a post like this:
"They are just a tiny operation with limited access to funds so they need to be able to access our bank accounts directly. Now there will be no more toxic fund raisers and they won't continue to exceed the share limit. Having direct access to our money will surely be the last thing they need to get them from the one yard line into the end zone. Calling it 'theft' and 'stealing' is just more misinformation and fudding by the shorts. The reports that that they are using the money to build out the manufacturing operation are lies. Sure, we've asked them these questions and they haven't given us a reason why they need direct access to our bank accounts, but that's still nothing to worry about. They are in a quiet period, so why would we expect them to say anything about that? Don't you know the rules?"
In general, I've detected more measured views on this board since the "Great ASM Letdown of 2021," but overall the continued excuse-making is still just unbelievably bad. There are some smart people here, including some who are very dialed in on this company, so how come no one has an answer for why they told us in writing we'd have TLD last September and then failed to produce? With all the knowledge and insider connections, how come no one can tell us why we are sitting here eight months later without TLD and the company hasn't said a word about what they put in writing last September? What an epic disaster.
I believe that your assessment is exactly correct, except that it omits additional complications with the current data. I agree with your speculation that the company chose to keep the trial going after never disclosing the highly likely 2015 futility recommendation to shareholders. To me, that was an egregious decision; not the decision to keep the trial going, necessarily, but the decision to not tell shareholders anything about what was going on. That was just wrong. Shareholders deserved to have a voice in the decision of whether to continue the trial or start over. Of course, NWBO has had almost six years to right that wrong by telling shareholders the whole truth of what happened, and have still chosen not to. That's not going to look good, imo, when all of this ends up in court.
Now that they have changed the endpoints after the fact, I believe they have a problem with invalid data. I'm not sure they have legitimate data to prove DCVax-L's affect on OS. That's why they claim the data is still being analyzed. We know they ran into complications with crossover among other issues that may have confounded the data. I think the switch to historical controls for comparison is an effort to mitigate this problem, but I am skeptical of how that will work exactly. After all, invalid data is invalid data. And I don't believe the FDA is or ever would be very receptive to these after-the-fact trial amendments.
I could be wrong about the particulars, but I'm pretty sure I'm not wrong that there is a major problem here. You don't announce, in writing, that you are going to release TLD in September 2020 and then not do it unless there was a problem - a big one - because here we sit eight months later with nothing. And, of course, they still haven't said anything to shareholders about any of it. The way they keep shareholders in the dark is what fuels my disgust with the people running this company.
Apparently the all-consuming desire for instant wealth blinds people to the obvious reality of an increasingly bad situation.
The TLD is not good and that is why NWBO does not want to share it publicly. They told us they would release it last June/July, but they didn't. Then they put in writing that they would release it in September 2020. But they didn't. Now, here we are more than seven months later and they are still refusing to release it, and giving absolutely no indication of when they might. Did anyone (other than me) listen to the 2020 ASM and think we would be sitting here one year later with no clue, with not a shred of concrete guidance, of when we will ever see TLD? And all of this is on top of the numerous occasions they have suggested over the history of this 16-year trial that data lock and TLD were imminent, and every time failed to deliver.
Some people are slow learners, I get that. Some people don't want to believe things they don't want to believe, and it's because they want to get rich. That's fine. But eventually all fantasy worlds collapse and the dreamers are forced to confront reality - in this case, the growing reality that NWBO may very well never release TLD. Like, ever.
Here it is in a nutshell: This trial is a colossal mess and the people running NWBO know they will be utterly humiliated when the facts become known, so they do not want the facts to become known. That's where we are. They have been lying to shareholders for more than five years. They completely changed the endpoints on a trial right before they supposedly locked the data. Now, why would they do that? And then they said they would use historical controls for comparison instead of the trial's own controls. These moves are blatant, 200-point-bold-font, fire-engine-blaring, neon-red-light-flashing-in-Times-Square indicators that the data is very, very bad. Otherwise, why would they make these moves? These are the questions shareholders should be asking. And then they should ask why the company would put in writing that it would release TLD in September 2020 and then not do it. Why did they not release the data when they said they would? Do we have an answer to that question? What happened? Why would they have felt so confident to put something like that in writing and then completely fail to follow through - and with no explanation whatsoever to shareholders? And now, seven and a half months later, still nothing except vague pleas for patience.
How much more patience can we have? At what point is it too much for them to ask for more patience? Is there even such a threshold for some people, or is everyone content to let this just keep going forever, until we are all dead and gone, or at least until the CEO has her drug manufacturing operation up and running? This company has pulled a masterful scam on compliant - and complicit - shareholders, and no one is the least bit interested in holding them accountable.
Been asking this question for almost four years, and I am going to keep asking until I get an answer: Why are they refusing to release the data?
The one thing we can be sure of from today's ASM:
The share price has clearly gotten ahead of itself again so they will need to tamp it back down. How they do that remains to be seen, but another can kick seems the most reliable tried-and-true method, perhaps coupled with a diluting financing and a scheduled vote to expand the share limit. As the company has made clear, they cannot allow the share price to get ahead of itself. For some reason a high share price doesn't fit with their plan of holding on to TLD forever. Must get that share price back down. That will be the objective of today's meeting, and if past public presentations by this company are a reliable indicator - and I think they are - then they will surely be successful. They are pros at not letting the share price get ahead of itself.
Yes, they think the share price rising in advance of another waste-of-time ASM is proof they are right and the skeptics are wrong. They can't seem to remember that at last year's ASM the CEO told us they would lock data by the end of May 2020 and we would have TLD by late June or early July 2020. That, of course, turned out to be a great big lie and shareholders never received an explanation. Then, they again promised - multiple times - that they would share TLD in September 2020. That turned out to be a lie, too, and again shareholders never received an explanation.
Now, there is much salivating over what will come out of the CEO's mouth tomorrow, even though there is absolutely zero reason to believe anything she says. She is a liar, and has been lying to shareholders for at least six years now as she continues to build out her manufacturing empire with our money and in such a brilliant way that none of us will ever see any benefit from it. She made a fortune off of Cognate, like a $100+ million fortune, and no one here seems to care. She's about to do the same thing with Advent. Or, she might just hang on to Advent and reap the steady income from the booming drug manufacturing business. That facility will be making a lot of really important drugs, but DCVax-L won't be one of them.
Why did they so adamantly state we would have TLD last September and then fail to produce? What happened? Does anyone here even care? Whatever happened, it wasn't good. That much we know. It is an incontrovertible fact that whatever happened last September it was not a positive development because it made them liars again and they never even attempted to give an explanation to help ameliorate the credibility damage. They just tried to pretend that they never promised TLD in September (or June, July and August before that). Do you think anyone will even ask them this question tomorrow, or will everyone just keep bloviating about a pre-ASM price run that is based on nothing? Why did NWBO promise TLD so many times but then fail to deliver? Over the history of this absurd 16-year trial, why have they made so many promises and failed to deliver e-v-e-r-y s-i-n-g-l-e t-i-m-e? I'll go out on a limb and predict "Nonsense!" "Balderdash!" and "Poppycock!" will be the first three responses to this post, with no substance whatsoever. That's always the response to anyone who poses these perfectly reasonable questions because, it seems, ignorance is bliss.
It's not about DCVax. DCVax probably works and probably helps people live longer. But the company in charge of proving that it does failed to do so because of the way they mismanaged the trial. Now they are trying to change the endpoints after the fact, which almost never goes over well with regulators. My guess is that the FDA is giving them a solid "No" on these post-hoc shenanigans. And to those of you who say it's not post-hoc, then ask yourself this: Why are they trying to change the endpoints? You think they just decided after 16 years these new endpoints are better? Yeah, sure. I'm sure that's it.
No, this isn't about DCVax. It's about the people running this company. They have shown us who they are over and over again. That's not going to change tomorrow. I've been asking the same question for four years now and I don't know if I will ever see an answer outside of a courtroom. Why are they refusing to release the data? No matter how many years and even decades they drag this out, and even after she kicks the can once again tomorrow, almost no one seems to care or even have the least bit of concern outside of three or four of us. That's what's so amazing to me. After all the crap, after all the lies, after all the failures to produce over and over again, after all the self-dealing self-enrichment at shareholder expense, no one even seems to care.
You are getting snowed again but no one has the intellectual capacity to process it. It's just incredible. This company screws us over every single time and you still come back begging for more thinking that this time it's going to be different. I mean, holy cow, she's already pulled this stunt once. She's going to pull it again. Do you not think that $875 million Cognate just went for didn't get her attention? It's happening all over again, and you are too to see it. Right in front of your face she's building up Advent - but not for you or me! Oh, no, she's building Advent for her! That's what she does. That's what she has literally done before and that is exactly what she is showing us is getting ready to happen again.
Just like Cognate turned out to be nothing in regard to producing DCVax, so will Advent. It's not about DCVax at all, but you continue to believe it. These people are crooks, and DCVax is a failed product. LP and her husband have gone full in on the manufacturing build-out and sell game plan, and NWBO shareholders get left holding the bag every time. Somebody ought to sue these people.