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Ha, ha, LOL! Can't wait to watch this board spin Bosch's pullout as some kind of bullish indicator. In fact, it's already started. "He withdrew from the conference. It must mean TLD and publication are right around the corner! Soon! Imminently!"
There's just no long-term benefit to living in a world of delusion. There is short-term happiness, but in the end it makes it all so much worse.
The excitement over Lykiri's post yesterday fails to consider that the quotes in the post make no reference whatsoever to whether the Phase 3 trial for DCVax-L was successful. In fact, the quotes simply confirm my belief that the company has withheld trial results in order to keep raising funds to build out its manufacturing operation. Looks like that manufacturing operation is about to be up and running. That's good news - if you are an Advent insider. The benefit to NWBO shareholders, however, will be minimal, at best, from a couple million dollars of DCVax revenue per year. Meanwhile, Advent will soon be making a fortune manufacturing other products. It's all taking shape exactly as you have all been warned over and over again.
Do you not see the blatant flaw in your logic? If the company decided not to say anything about the endpoint changes because we super-smart shareholders should know that if they say nothing it means the new endpoints were accepted, then why would DI then turn around and make such a statement to Reefrad? Wouldn't that be a clear violation of the company's agreed-upon policy? Especially when he knew it would be broadcast all over this message board? Uh, whoops. What justification would there be for clarifying this important fact with one shareholder, but not all?
None of it matters because nothing that the NWBO IR clown says is true. He is an established liar. None of it makes any sense whatsoever, unless you accept the fact that this is an outright scam.
It's amazing how (some) longs will admit the only chance in hell this thing has of getting FDA approval is if the rules are changed, the endpoints are changed, and the trial's comparisons throw out the trial's own control arm in favor of cherry-picked historical data that at least one poster here recommends should be synthetic (faked) data. And we sit here with no clue where this is going 15 months past unblinding when the company actually got to look at the data.
And yet, those same people call us skeptics crazy! They honestly think all of us these things are somehow going to magically materialize into approval when history shows in reality that thinking just one of these things will happen is completely nuts. These things don't happen, period. You can't run a trial for 15 years and then change the endpoints right when you lock the data. You can't substitute fake data for the trial's control arm. What's worse is the company has known for six years that these attempts to shift the rules to benefit the trial data are way beyond a long shot. It's obvious in the fact that none of the official trial record has been updated in years. It's obvious that the statements they have made, and the timelines they have given, have been lies. They've known that in any honest evaluation of the situation this trial would have been deemed a failure in 2015 if not before.
But the longs tell us that it's the skeptics who are intentionally trying to sink this stock and company by peddling lies and false information. These things I have mentioned above are not lies or misinformation. They are facts, and any honest reading would HAVE TO acknowledge that the odds of the company pulling this crap off are one in a million. Maybe a couple of the skeptics have an ulterior agenda - probably do. But I have no agenda beyond getting to the truth - and the sooner the better. I'm just a small-time shareholder who can afford to stick this out, who was once a loud pumper for the company and its management, but became completely disillusioned with the bullshit a few years ago.
You are welcome to continue believing that some crazy miracle is still going to happen, but eventually you, too, are going to come to understand that what this company has done, and is doing now, to shareholders is flat-out wrong. Welcome to 2022 people! Did you think in early 2020 that you would have trial data that year? Did you think in 2021 you would have trial data in 2021? And now you think you are going to get it in 2022? And you call us crazy? Get real. Seriously, get real!
I noticed that, too, and thought the same thing. So this is their new business model? Suing over patent infringements as a revenue stream? What a pathetic joke. This article seems to be clearly setting the table for the obvious trial failure that is coming.
Don't worry. I saved a copy of the timeline web site you created so it can get the attention it deserves at the proper time. Cheerleaders have come and gone over the years, and there have been similar timelines created in the past pointing to guaranteed positive data being released imminently - I remember a fairly lengthy one someone posted in 2017 or so. But the one thing these timelines have in common is that they never amount to anything. No data is ever released. It's all for show. All part of the game, and keeps a few folks hanging on while the company execs spend their most recent $15 million money raise on themselves. Until it's time for the next money raise.
All the complicated analysis and due diligence can't seem to get past one simple fact, which is that companies with positive data don't sit on that data. Never have and never will. It just doesn't make any sense. It's almost as if the people who do all this complicated analysis and due diligence, the same people who come up with all these excuses for why a company unblinded since at least Oct. 5, 2020 still hasn't released top line data, have never stopped for one minute to ponder why a company would sit on positive, efficacious trial data for more than a year. Because the obvious answer is that no company ever would. Those people cannot process what it means when a company promises TLD three times in 2020, then announces they locked the data and became unblinded on Oct. 5, 2020, and then we don't hear another word about the data for more than 15 months. Somehow they think that's a positive thing?! The company got a look at the data and suddenly turtles up into a shell of silence for 15 months and counting, and that's a good thing? I mean, what do you think they saw when they looked at the data? Because it sure wasn't anything positive or efficacious! To argue otherwise is pure stupidity.
The people who are running this company have been lying to shareholders for a long, long time. It was pretty funny that this morning someone posted the lawsuit from 2007 when the company lied about the status of DCVax-L in Switzerland. That lie was specifically intended to boost the share price, which it did. And that episode did not deter them in the least because they have made multiple false statements since (everyone should come to the shareholder meeting. It's going to be interesting!) (We anticipate the release of top line data by June/July/September 2020) that have also boosted the share price right around the time they were about to announce another money raise and handing out warrants like candy. This is all a game. If you were to define a shareholder scam, how would it look any different than this? It would look exactly like this. If I were you I would be careful about getting caught up in what is coming next, because when the lawsuits start flying it's not going to be pleasant for anyone at NWBO or anyone who has been doing their bidding. That little web site you created is going to come in handy!
If the 2018 paper showed the trial is a success, then why haven't they submitted a BLA and where is FDA approval as we are about to enter 2022? If the data showed success in 2018, then why didn't they stop the trial then and begin the process to certain approval? If the data was so good then why did they keep the trial going? Something doesn't add up with your argument, and the reason is because it's all a lie. They paid to have that junk paper published in that third-rate journal because no credible journal would accept it. You do know that right?
Companies don't sit on positive data. No company in history has ever sat on positive data. Never. It's just stupid to suggest a company would. NWBO does not have positive data, and that is why they are refusing to release it 15 months past data lock and unblinding. It's all a lie and shareholders are being scammed. The excuse about waiting for yet another journal so they can release the data the right way is just laughable. It has zero credibility because, again, companies don't sit on positive data. And we are now 15 months past data lock so where is the journal article? This is so absurd, and no one with any common sense at all is buying it anymore.
They've got their Sawston certification, so now they can either bury the failed trial in a regulatory filing or just not release it at all. Now they move toward developing their manufacturing operation and figuring out how they will cut NWBO shareholders out of the profits, which will likely involve Advent or a third party buying the property. She has done this before, so we know what is going to happen. Don't believe what people say, believe what they do. She did this before with Cognate and she is going to do it again. You all know this is true, and yet you still prefer to believe in fantasies. I've been telling you this is a scam for three years now.
Merry Christmas everyone! Hope your fantasies of an efficacious cancer vaccine come true! And despite what you might think, I mean that.
Certification was a certainty, but I'll admit I didn't think they would get certification by year end for the simple reason that that's when they told us it would happen. We all know what happens when NWBO sets a timeline. Then I remembered that it's not their certification. It's Advent's. So that's what explains the timeline actually being met. If it had been NWBO's timeline it never would have happened - that's a 100-percent guarantee because NWBO has literally never once met a timeline, not once, not ever.
What's especially amazing here is the people who continue to say the fact we are 15 months past data lock must mean the trial was a raging success. They talk about fictional four-day rules (no such rule exists) and how the company would have to disclose material information if the trial failed while totally disregarding that the company is actively trying to change endpoints and cherry pick historical data in a desperate effort to find some random subset of a subgroup where they can show success. That's why they have not announced the material information - they are still playing games. They are still in denial, or intentionally prolonging a fraud, or, perhaps they just won't release the data at all. That's actually not uncommon for companies with failed trials.
The truth is that no biotech in history has ever waited 15 months (and who knows how long this will actually end up taking) to release positive top line data that shows efficacy. It just doesn't happen. And it's not going to happen here, either. So, to those of you who think the long wait is actually a guarantee of success, I would encourage you to go look at the facts. Companies with highly positive data do not hold on to the results. That is a fact. All of you who believe otherwise are wrong, and history proves it. There are plenty of examples, though, of companies holding on to data when the data did not meet the endpoint targets. Sometimes, those companies just buried the results and pretended like the trial never happened. Wonder if that's what will happen here.
Now, don't get me wrong. I'm not saying it's impossible for NWBO to become the first company in history to wait this long to release successful trial results. I'm just saying that believing that to be the case is completely delusional.
This argument is so tired and worn out. It might have held some validity a year ago, a couple of months past data lock. But now, in the 15th month past data lock, it is no longer even remotely valid. The company hasn't told us anything about how this is all being held up because they are having trouble getting signatures. LOL. That's just something you made up in your head because, well, at this point there just aren't many other excuses left. "Yeah, that sounds good. They are having trouble getting signatures!" What a joke.
Yes, that's exactly what this trial needs - more time! NWBO just hasn't had enough time to conduct a Phase 3 trial and release results. All of this is just going to take more time. It's obvious that more time is needed to do all of the things that still need to be done, and the CEO has only been CEO for 10 years so she needs more time to get acclimated. The trial only started just over 16 years ago, so there clearly has not been enough time. And since they announced data lock and they became unblinded, there just hasn't been enough time to release TLD. But if everything goes well then in the coming months they might have enough time to get it done. And, who knows, maybe they'll have time to get certification on Sawston, too, and have enough time left over to uplist.
All of these things take time, you see, and NWBO just hasn't had enough of it. In the coming months, though, we'll find out if they need more time. I'm guessing you guys will be willing to give them all the time they need, so the odds are pretty good they will use every bit of it - and then, in the coming months, they'll use some more!
What a bunch of BS. They have never said they are withholding TLD until they have an article published. That's a total fiction. Why would they do that? The whole point of TLD is to just give a quick snapshot of how the trial did and whether it successfully met the endpoints. Almost every biotech in the history of the world has released a TLD statement of some kind within a matter of days of data lock. That's a fact. Some of those announced success, and some of them announced failure. The one consistency among the small subgroup of companies that chose not to announce TLD is that they were all failures.
NWBO hasn't even told us what the endpoints are, much less provided TLD showing whether the trial met these endpoints. What you are stating as fact simply is not true. They have never said anything about holding TLD until they have a publication. Why? They have the data now. If the data is good, then why not release it? There is absolutely ZERO reason not to release positive data. This trial is a colossal disaster, and NWBO is circling the drain.
Why do you continue to post the study about how long it takes companies to go from positive TLD to publication? We don't have positive TLD! This study is completely meaningless. It has no relevance to NWBO until they release TLD.
Why are they refusing to release TLD? Where is the data they promised in September 2020 (and in early July before that)? What could possibly have happened after they locked the data and became unblinded that would make them not want to release it? Gee, I wonder. Seems so strange. I'm just baffled at what could have happened after they took a look at the data that made them not want to release it. I just can't figure it out. What could they have seen? It's just an enigma wrapped inside a mystery.
Dutch Boy:
It's only incompetence if you assume that all the bogus timelines and misleading statements going back more than a decade are innocent mistakes.
They are not.
The reason they are not releasing the data has nothing to do with a journal. They could release TLD any time they want. They've been unblinded since October 2020.
The reason they are refusing to release the data is because it is bad. That's right, the data is bad. I mean, could it not be more obvious? What else could they possibly be (not) doing to make people realize this is a failed trial, and that you can't change endpoints after conducting a trial for 16 years, and you can't use historical controls to make valid comparisons? It is a failure. That is why they haven't even bothered to update the trial register. Failure is BY FAR the most likely and plausible explanation for why we haven't seen the data.
They are waiting on certification for Sawston to announce it. That makes perfect sense. You don't want to announce the trial failed now, before you get certification, because everything could collapse. But if you wait until you have certification, then you have something to fall back on (at least for Advent) and it is highly unlikely that everything would collapse.
Unfortunately, when that happens, I think there's a good chance NWBO shareholders will be left on the sideline as Advent ramps up into a full-scale manufacturing operation - like Cognate did before it sold for $800 million. Believe me when I tell you that sale got her attention. When she saw that Cognate sold for $800 million just a couple years after she had sold it for a lot less, I think a light bulb went off in her head. She doesn't need this failed vaccine anymore, and she doesn't need NWBO shareholders anymore, either.
I am not only still claiming it is a scam, I believe the evidence that it is a scam grows more and more palpable each day. Also, insiders not leaving a scam they created, have perpetuated and are benefiting from, is not unusual at all. Often in the cases of known scams, the insiders have convinced themselves they are doing the right thing even when they are not. This happens all the time, and there are numerous prominent examples.
As I have said many times, I believe this company was aware of an efficacy IA conducted in or around 2015 that showed clear failure on at least the then-primary endpoint of PFS. That's when this operation officially crossed over into a scam, in my opinion. That's because the company did not disclose the efficacy IA results, but instead decided to shift the entire focus of the trial to OS, and then later to the long tail. By choosing to not officially accept or officially recognize the IA results, they could just pretend like it never happened. Instead, they just quietly gleaned what they wanted to know, probably in an unwritten format (could have been as a simple as a one-sentence phone call from the agency that conducted the IA saying, "It doesn't work"), and then went ahead with making decisions to keep the whole process going with the same sunny optimistic outlook that earth-shattering, game-changing, cancer-curing results were imminent even though they knew it was all a lie. They should have disclosed what they learned in 2015, and they should have started the trial over and run it correctly. But they decided to keep plowing ahead knowing full well that one day they would have to completely change the endpoints of the trial and shift to using historical comparisons instead of the trial's own data. They knew that at best this strategy was a total craps shoot, but they persisted and continued to raise tens of millions of dollars. They have paid themselves many millions of dollars each since learning that the trial was essentially a complete failure. That, in my opinion, constitutes a scam. What we will learn is that in the eyes of the FDA, conducting a trial for 16 years and then at the last minute, right before data lock, trying to change all the endpoints and switch to historical controls was not only a non-starter, it was a laughably embarrassing attempt to cover for failure - a failure they had known about for six years.
So, yes, I think it is possible that through it all they convinced themselves they were doing the right thing, and maybe they actually believed they would be able to convince the FDA on the endpoint changes and the historical controls, but that doesn't excuse the fact that they were, in fact, not doing the right thing. It doesn't excuse the fact that they failed in their fiduciary duty to shareholders to disclose material information. But the fact that no one has resigned doesn't mean much of anything to me. It just means that they are all in on it, and they all are enjoying the benefits.
What would be telling, though, is if an outsider were to come to the company. I can't think of an example, but let's say, strictly hypothetically, that a fairly reputable doctor from, oh, I don't know, maybe Merck, was to join NWBO at the executive level. Now, that could be interesting because that person would be bringing an outsider perspective. They would not have been part of the transition, the slow frog boil that led to one bad decision after another. It would be interesting to see what such a person would do after joining the company and having a few months to look around and see what was going on. Assuming that hypothetical individual had a decent moral compass, I think it would be a lot more telling to see if that person actually stuck around. I can't think of an example, though. Can you?
Wake up, people. Don't let yourselves be lied to over and over. It's time to hold these people accountable.
Dude, just take the L. There is no contract. Secret agreements floating in the imagination like unicorns are a sad reflection of how far this whole thing has regressed.
My belief is that NWBO has been told in no uncertain terms by the FDA that their SAP is rejected, that they cannot change the endpoints on a 16-year-old trial, and so, therefore, they have no need for a contract with CRL. That's where things are. Sorry if that disappoints you or ruins your figgy plum pudding dream.
This is exactly correct, except that I would say a more accurate description is "Ponzi Scheme" rather than "shell game", but close enough. Is there anyone who does not understand they are using the $15 million they just borrowed to pay off the $11 million they borrowed last time? They don't have any other revenue, so that is exactly what is happening, and anyone who thinks they now have $15 million to put toward their never-ending "processes" is insane. That money is already spent. Whatever is left over after they pay off the $11 million loan will be used to pay their $600,000 salaries. On second thought, I am certain they will pay themselves first.
This is a scam, folks. They are not releasing TLD, at least not until they have certification on Sawston. You all know that's what is happening. DCVax may actually work, and might actually work pretty well, but this 16-year-old trial was unable to prove it because they botched the trial in so many ways. That's why they are withholding the data. Every single one of you knows dam well that if the data were exceptionally good there is no frigging way they would still be sitting on it 14 months after data lock. No way. Not a chance. It's just not an idea that any sensible person would even entertain.
The truth is, NWBO doesn't even know what the endpoints are. Seriously, they don't know the endpoints because their crazy plan to conduct a 16-year trial and then, in a last-minute panic move, change the endpoints right before data lock, has not been approved by the FDA and probably won't be. It's just hare-brained to think the FDA would allow them to do that, and don't try to ply me with all the nonsense about "new definition of GBM" and that rules and policies have changed and all the new information we have learned about the science since the original endpoints were set and blah, blah, blah. It's all nonsense. If any of that were true we would have seen the data 14 months ago!!!!! They've had 16 years to figure all of this out, so if that argument was true then why weren't they ready when they locked the data? Wouldn't you want to make sure you had all of those changes nailed down and approved before you locked the data? The fact that they weren't ready tells me they did not get those approvals and those changes were not accepted. There are strict tried-and-true methods for conducting scientific trials and there are very good reasons why deviating from those methods is just not acceptable.
And that's why they aren't releasing the data - the data they have been unblinded to for 14 months. They are trying to hold on until they get Sawston certified and they can become a manufacturing operation. At that point, they will tell us the trial failed and that DCVax will not be part of the commercial production at Sawston, but they are working on other contracts. Then they will have to figure out what to do about the NWBO-Advent relationship, because it is not sustainable. If I had to bet, I would wager that NWBO shareholders will get cut out of the picture altogether because that makes the most sense. Get ready folks.
This is all you guys have left. You think you are trying to convince others that the reason they haven't released the data 14 months after data lock is because the data is so overwhelmingly good, but really what you are doing is trying to convince yourself, because even the most die-hard longs know in their hearts that it's a lie. They know that companies do not sit on overwhelmingly positive data - ever. Never have, and never will. No one ever would, because anyone with a brain knows that data speaks for itself, and that all the claims about shorts tearing this down when they release overwhelmingly positive data is beyond absurd. The shorts might try, and they probably will, but data speaks for itself. There's no way around that. Facts are facts, and no amount of short attacks would ever be able to suppress overwhelmingly positive data for long. You know it, I know it, and everyone in the world knows it. But keep on with the propaganda, if it makes you feel better.
Not according to many here. I've read several times over the last few days about how the longer this takes the better the data must be. Using that logic, if this takes an eternity then it surely must mean the vaccine will cure cancer - with the minor caveat that no one will ever benefit.
This is all so insane. It's upside-down world, and the people still defending this company know how bad it all smells, but they think that because they own shares they have to ignore reality and continue to pump an obvious failure. Of course, that's not true. If this is a failure and the company is hiding the data, it is in everyone's best interest to bring this to a close as soon as possible. The longer this drags on, the worse for shareholders and, especially, cancer patients who are being misled.
Once you've been here as long as I have, you figure out it's all just a game. Always has been. The objective is to keep this trial going in perpetuity, and they have a PR operation that helps facilitate the objective by posting bull---t on message boards about tote bags and such. If it's not tote bags, it's some other elaborate connection of dots that proves the company is oh-so-close to releasing the ever-elusive data from the DCVax-L Phase 3 trial. Maybe it's the next ASCO conference with the monstrous booth, or the upcoming ASM, or maybe someone has found absolute certain proof that the company has submitted data to NICE for approval. The NICE submission was the mantra a couple of years ago, sort of like the tote bags are now. These are all things we have been through over and over again, year after year, and they never once have proven to be true. Every time we are told the company is working quietly behind the scenes on some grand plan to surprise us all with wonderful news, it turns out to be not even close to true.
That's because it's all intentional lies. This whole operation is a coordinated scam. Everyone here is welcome to believe what they want, but when you step back and look at the whole thing objectively, that's when you see what is really going on here. It's an elaborate game. Don't be fooled by false prophets.
You know there's a delicious irony here that I'm not sure anyone has picked up on with the tote bag. It's a brilliant analogy, because in the end that's what NWBO shareholders are going to be left holding.
It's almost like it's an intentional chef's kiss to shareholders. Just amazing that as one of their last acts before announcing the failure of the DCVax-L trial, they chose to literally leave shareholders holding the bag. What a company!