You do realize that with the interim report they could not find a single respectable journal to publish it. They ended up having to pay to have the article published in the Journal of Translational Medicine or whatever it was called. They paid to have it published on short turnaround with no peer review.

To assume this delay is the result of their accepting a "better offer" for publication is beyond absurd. In fact, this whole wait has nothing to do with publication. How could anyone justify letting cancer patients die while they waited for just the right publication? Seriously? Why the hell can't they just release the TLD, or pay to have it published in the JTM again? Isn't the whole point of this to save patients' lives? This is so dumb, and anyone who believes the publication ruse is utterly delusional. The only possible explanation is that the data is not good and there is no publication willing to put this sham, with its post-facto endpoint changes and reliance on historical comparisons, in print.

The only thing we know for sure is that they are not nearly as close as people think they are. That's because this is a giant scam. Exwannabe posted a link earlier to LP saying seven years ago how close they were. I mean, how many times can you listen to this crap? How many years can you go hearing them talk about how hard they are working and how close they are to the finish line before you start to question what is really going on? How many years can you go hearing them lay out all the processes that need to be completed? How many years of quiet periods can you endure? How long can you do this before you figure out it's all a lie? The only leverage they have to do anything is by keeping this trial going forever. Why would anyone not be able to understand that by now? I mean, some of the newbies here, yeah, I guess I get it. But you?

All it would take to advance toward the finish line is to release the data they've been unblinded to since October 2020. But they won't. Claiming that a 30-minute presentation detracts from this effort in any way is just another lie by the company's IR guy. This guy does nothing but spew misinformation and lies, and he shares material information with individual shareholders in phone calls that then get reported on this message board. How long has he been talking about how hard they are working moving toward the finish line? Years now. They are liars, and they are sitting on data from a failed trial while they get their manufacturing operation up and running at Sawston, a manufacturing operation built with NWBO money that will have almost nothing to do with making DCVax-L. What a pathetic sham!

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.

So, what's the pump for today? What will be today's excuse for why this company continues to hide the data from its Phase 3 trial for DCVax-L?

Will it be "waiting for publication and, oh yeah, they're in a quiet period" again? Yeah, that's a good one. So much potential for that one because it fits neatly into whatever timeline you want. It's been six months since unblinding and no TLD: "waiting for publication and, oh yeah, they're in a quiet period." It's been a year since unblinding and no TLD: "waiting for publication and, oh yeah, they're in a quiet period." It's been a year and half since unblinding and no TLD: "waiting for publication and, oh yeah, they're in a quiet period." And so on, and so on, and so on, ad infinitum. It really is an amazingly powerful excuse for kicking a can pretty much as far as one wants.

Or maybe today we'll fall back on COVID. That's always a good one, too. You can cover so much ground with the COVID excuse. When you think about it, you can blame just about everything on COVID!

But perhaps the best excuse is the relatively new speculation they've already submitted a BLA and are waiting to surprise us all with FDA approval. That's a really good one because it just makes so much sense! After all, it happens all the time. That's the way new drugs and treatments are usually approved - just skip the whole TLD and publication/presentation process and jump right to approval! Fantastic!


In September! Of 2020!

I'll tell you my bet. I bet Joan had an awesome Christmas with lots of presents paid for by NWBO's PR firm.

LOL. This stuff is so good. It's all there in print. No need to make anything up. This must be one doozy of a publication we are waiting on. Those NWBO folks and scientific team must be working really, really hard right now to get that Word document and spreadsheet formatted just right. Pedal to the metal, baby! Maybe the holdup is they can't find the right pictures to go with it. I know sometimes that can be hard, but having the right pictures makes such a difference for your publication. As can making a pretty cover page, and sometimes formatting the table of contents can be a real pain in the you know what! I can see how all of these important details might take a few more months. And COVID. And the BLA they've submitted. And, oh yeah, they're in a quiet period. Can't forget that.

Sometimes I wonder if NWBO shareholders have any idea how hard the rest of the world is laughing at them. It's such a sad, sad joke.

LOL, keep dreaming. Hey, it took a few years but even Chris LaCoursiere came to his senses eventually. Everyone does, eventually. Just gonna take a little time. But don't worry, NWBO's got plenty of that! LOL!

Some of us have been here a while, so we've been through all of this before. It is nothing new. It is the same story every time, and you don't have to be a genius to figure it out. It's been the same cycle, over and over again, back to at least 2013. And now we know that even locking the data and becoming unblinded has changed nothing. They are going to keep playing this game as long as they can keep raising money.

We all know that if the data were good we would have seen it by now. We all know that, and we know that the reason they are hiding the data is because it is not good and they cannot get any traction with their post-hoc efforts to change endpoints and use historical comps. That is all incredibly obvious to anyone with a shred of common sense. But, hey, keep dreaming! LOL!

No, but they have been sitting on a failed trial for six years and hiding it from shareholders. They have also raised money totaling in the hundreds of millions of dollars all while knowing the trial results would not be approvable, and they used that money to pay themselves $600,000 salaries as well as set up not one, but two separate manufacturing operations, funneling money to private companies that she also happens to own. Pretty crazy how brazen the whole thing is. I mean, I agree they are not hiding anything. She actually set up Cognate using shareholder money and sold it right under their noses. She's done it before, so it's no big secret. It's all right out in the open - well, except for the trial results! The trial results are the mystery that keeps the whole thing going! As soon as they pull back the curtain on those results, party's over!

There is no good reason to be sitting on top line data for more than 15 months after becoming unblinded - none whatsoever. There is, however, another reason why they would do that.

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.

They will need to sign some contracts, first. But that's coming. There are plenty of companies that will be interested. I suspect it could turn into a rather profitable operation. But then the question becomes what to do about NWBO, because it makes no sense for Advent to be manufacturing in a facility owned by a public company whose CEO also owns Advent. It's just not a sustainable arrangement because of the ethical implications and tax complications, so as soon as Advent is generating its own revenue and no longer needs NWBO, I suspect Advent will buy the facility from NWBO at a substantial discount. With any luck NWBO shareholders might get a thank you note.

But the bigger question right now is whether the CEO of NWBO used the promise of TLD to raise $15 million that she then turned around and spent some portion on Sawston. That's a really interesting question, especially if it turns out the DCVax-L data is not very good. In that case the appearance, at least, is that she withheld material negative information in order to raise $15 million to spend on a separate company that she also just happens to own. In other words, she raised $15 million that will be used to pay not just her NWBO salary, but also will at least partially benefit her financially through her Sawston/Advent/Toucan ownership. It would be such a remarkably blatant scam that you have to almost admire the brazenness.

Can't wait to see that TLD! We are going to see it, right? Oh, wait, it turns out there might be some additional Sawston/Advent projects she needs to take care of before we can see that TLD. Those Sawston projects are going to cost more money and right now the only place Advent is getting money is through NWBO and its shareholders, so it looks like TLD might just have to wait a while longer. Sorry!

Hmm, interesting logic. Would you assume these people were in on a scam?

Henry Kissinger (former United States Secretary of State);
Jim Mattis (retired Marine Corps four-star general);
George Shultz (former United States Secretary of State);
Richard Kovacevich (former CEO of Wells Fargo);
William Perry (former United States Secretary of Defense); and
William Foege (former director of the Centers for Disease Control and Prevention).

They were all members of the Theranos board.

What about this guy?



Your argument holds zero water. The only person who decides when to release TLD is the CEO. That is her decision. The decision to withhold the data from shareholders while moving forward with a $15 million fund raise has nothing to do with those other people you mentioned.

The parallels with Theranos are becoming more and more clear with each passing day. Theranos did, in fact, have a product. It just didn't work, and the CEO went to extraordinary lengths to cover that up. Sounds a lot like another company I know. You know, I know, and everybody knows, that if the data were good we would have seen it a long time ago.

Love how every day iHub posters find some new way to lower the standards so that not only can NWBO's failed trial somehow pass, but Flaskworks can get approval, too. If you guys just wait long enough, maybe there won't even be an FDA or an MHRA anymore! Maybe they'll just let companies grant their own approval for drugs and manufacturing processes. Wouldn't that be awesome! No more of these pesky regulatory standards!

FYI:

Theranos CEO: Guilty on four counts of wire fraud
NWBO CEO: Still on the loose, and still engaged in some highly questionable practices.

Just wondering what you folks will think when you find out the company became unblinded on or before Oct. 5, 2020, and then proceeded with a $15 million capital raise without telling shareholders anything about the data they have looked at and analyzed? If it turns out that data is not quite as good some of you are expecting, what will you think about the company making this move without informing shareholders? Hypothetically, of course, but if they knew the data is not good and the company then raised $15 million, a large portion of which went to pay Advent for the Sawston buildout, what would you think about that? Seems a little sketchy, doesn't it? Asking for a friend.

Wouldn't a reasonable person have said the same thing about the fourth quarter of 2021? Or even the third quarter of 2021? How long after locking data and becoming unblinded does it take to release TLD? People have been saying the same thing for years, that if we didn't have TLD in 2020 we could write off our investment. Hell, the company itself has promised TLD numerous times over the years going back to 2007, and did so three times in 2021. This is not new. I'm telling you, this has happened over and over again and it never changes. It never will.

They are not going to release this data. The data does not show what they want it to show, for whatever reason, and they are not having any success trying to change the rules, the endpoints, and the comparative data, all after the fact.

But you know what's even more amazing? After Q1 2022 passes with no data, the same crowd will still be here making excuses - there might even be a few new ones depending on whether NWBO's PR firm enlists some more iHub handles. Guaranteed. After Q1 we'll be talking about the ASM, and then ASCO again. It's Groundhog Day in NWBO land because no one wants to snap out of their delusional dream and acknowledge the obvious truth.

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.

I mean, what kind of sentence is that? ". . . could be a likely . . ." What? They locked the data on or before Oct. 5, 2020! Could she go any further to cast doubt with all this couching? I think it's looking more and more like they aren't going to release the data at all. But hey, those patent infringements seem like a pretty reliable revenue stream! LOL!

We now have people posting about using "synthetic" comparisons instead of the trial's own control arm. It has gone beyond ridiculous. Some people just don't understand how the scientific method works. They think the company can just change all the rules, change all the endpoints, change all the definitions, and use fake cherry-picked comparisons to make their data look good. Does anyone really believe that's going to fly with the FDA? The fact that we are sitting here in total darkness 15 months after the company claims it locked the data and became unblinded tells you all you need to know about how much success they are having with this strategy. This whole thing is such a joke, and it really is bordering on being criminal.

Do you know how insane it sounds to keep insisting that NWBO has some world-changing trial results that it is about to reveal? Not sure why anyone would still believe that, even if it pays well. The company promised TLD three times in 2020 and never delivered. Then they said on Oct. 5, 2020 they had locked the data (after promising TLD in September). After they locked the data and became unblinded, they went totally silent. No more promises of TLD. Now what could they have seen when they looked at the data that would make them go silent? Must have been those world-changing results! And now here we are, 15 months later, with . . . nothing. The scam continues as long as they can keep finding sharks to lend them $15 million. Wonder how much of that $15 million went to pay for fancy Christmas vacations and presents for NWBO execs?

And why are you bringing LL into this? She doesn't have anything to do with NWBO anymore. Won't even mention the company's name. She's doing her own thing now because she knows what a disastrous mess NWBO's Phase 3 trial is.

I see that NWBO's PR operation continues to thrive on iHub, even as the stock is sinking like a stone. This company is run by liars. That's all you need to know. She will never release the results from this trial unless they are buried at the bottom of a regulatory filing. As ex said yesterday, funding two CDMOs on the backs of clueless shareholders waiting for results from the same trial is a master-stroke of corrupt ingenuity.

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.

The market is telling you that this isn't the case. The market is telling you the value of NWBO's manufacturing operation at Sawston, without commercial production of DCVax-L. Because the manufacturing piece is all they've got.

They have a failed trial and they know they cannot get approval for DCVax-L no matter how many endpoints they change and no matter what historical data they use for comparison. They've actually known this for at least six years. It's about time everyone here woke up to this simple reality.

Companies with successful, efficacious trial data do not sit on that data for 15+ months. Sorry, but that's a fact no matter what excuses you want to invent.

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 goes back to the age-old misunderstanding that pervades this message board. There's a simple axiom here that so many just don't seem to grasp, and that is this: DCVax-L might very well work to some extent and in some capacity in some applications and be perfectly safe. Not even I would disagree with that. But that fact has absolutely nothing to do with whether NWBO's Phase 3 trial was able to prove that it works. On that question, I am a hard No, because they botched this trial in so many ways and now they are trying to cover for it with new endpoints and historical comps and all that mess.

So, MHRA could very well agree with me and everyone else that DCVax-L works to some extent and in some capacity in some applications and is perfectly safe, and therefore they might grant certification for its manufacture and the manufacture of other DC products. But none of that has anything to do with whether NWBO's Phase 3 trial is going be successful and the product approved. None. They are separate and distinct processes.

Instead, Sawston is going to end up manufacturing other DC products almost exclusively, and when that happens it is going to become very clear the current relationship between NWBO and Advent is not sustainable. Advent will begin to grow rapidly, and it will become clear that NWBO is an unnecessary component of the manufacturing process, and since both are owned by the same person, well, guess who is going to be left holding the bag. It will be NWBO shareholders as the CEO quickly moves to absolve the public entity that has been nothing but a headache and will, at that time, be nothing but an impediment to the manufacturing process, and proceeds to make tens of millions with her new manufacturing operation called Advent Bioservices.

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.

OK, how about 15 months?

Of course, none of this - not even an alleged difficulty getting signatures (LOL) - precludes them from releasing TLD as every normal biotech company in the history of the world has done shortly after locking data. There's just no reason not to release positive TLD, and everybody here knows it whether they admit it or not. That's because everybody here knows that truly positive data speaks for itself. Neither AF nor anyone else can tear down factual data points that show patients lived longer after receiving DCVax-L. If you have TLD that clearly shows a separation of the arms and that patients lived longer, then why would you sit on it for more than a year? AF would look like a complete idiot if he tried to dispute obviously positive results, and he's not that stupid. And as many have pointed out already, what could AF do that would be more destructive to the share price than what the company itself has done over the last 15 months? This just isn't as complicated as everyone here wants to make it. Either patients lived longer or they didn't. Where is the data?

Obviously the data just isn't quite as wonderful as so many here desperately want it to be. That's why they aren't comparing arms. That's why they are using historical data instead. And that's why they allegedly are trying to change the endpoints on the trial after-the-fact (although there is no proof that the endpoints have been officially changed, especially in the U.S.). So my guess is they will try to spin the results as positive no matter how bad they are, which is why they feel no obligation to release negative results. As long as they don't think it's all bad, they don't feel like they have to inform shareholders. Another possibility is that they just don't care about rules regarding the release of material information. They proved this in 2015 when they withheld material information from shareholders regarding the enrollment halt and a suspected undisclosed efficacy IA, and now, if the trial is a complete failure as I believe, then what difference does it make if they broke some rule? It just doesn't matter. It's all over anyway. The other possibility is that they just aren't going to release the data at all. That's the outcome I've always suspected, and I think it is becoming more and more likely with each passing day. They just aren't going to release the data at all. That's actually a fairly common tactic of companies with failed trials.

Someone should ask Dr. Linda Liau! Oh, that's right, she doesn't want anything to do with NWBO anymore. She's so disappointed with how all this has turned out, she won't even mention NWBO anymore - hasn't for a couple of years. What an embarrassment!

Oh, well. It's all about Sawston right now. And by the way, weren't we promised Sawston certification by year end? Two more weeks to go! Does anyone here really think they will have certification by year end? Or, did they just put out another completely false timeline? Are these people just compulsive liars? Sure does look like it!

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.

Well, here's all the evidence you need that, as some of us have said all along, THERE IS NO CONTRACT WITH COGNATE OR CRL!!!!!

They have no manufacturing agreement in the US, period. That's because they have nothing to manufacture and never will. If they can get Sawston certified, and that's increasingly looking more and more doubtful, then Advent will be manufacturing other companies' drugs. And when that happens, NWBO and its shareholders will be left out in the cold because they will have no product to make and their only asset will be the facility itself. As soon as revenue starts booming for Advent, and it will, NWBO will be pushed aside as Advent becomes LP's new business model.

You don't need Tarot cards to see that this is going to happen. The writing is on the wall in big bold letters, and it's obviously the only reason NWBO is still refusing to release the data from their failed trial. I've been telling you this for a long time, so you can't say you weren't warned.

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.

If you had dealt with lots of these kinds of issues, then you should know that the contract itself is the termination agreement. The contract sets the terms of the agreement. There is no other documentation that needs to be disclosed.

There is no agreement with Cognate or CRL in place, and that is why NWBO took the active step of removing all references to the now-expired contract from their regulatory filings. This isn't difficult, and it's not a matter of me believing whatever I want. Just like the lawsuit ruling that you somehow think precludes all possibility of the company having been aware of an IA in 2015 that they, conveniently, did not acknowledge, officially accept or disclose. They just decided to change the whole direction of the trial. You think that decision, and their removal of the Cognate contract language from regulatory filings, were just spontaneous coincidences? Nobody but you believes that, and the truth is, I don't think you really do, either.

The constant effort to over-complicate simple realities (such as pretending being 14 months past data lock with no TLD is perfectly normal when the simple reality is that the data is bad and they've known it for six years), is just another tactic in this year-long shameful scheme to obscure the truth.

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.

Is it possible to write this statement with a straight face? Perhaps you are referring to the "facts, not speculation" contained in their August 21, 2020 press release:

"The Company currently continues to anticipate reporting topline trial data in September [2020], and anticipates providing further updates as the process progresses."

Here's the link

Is that what you meant? How about:

- The many other lies and misleading statements they've made over the years about the conclusion of the trial being imminent (literally dozens of examples)?
- Or how they just can't seem to be able to release results from a trial they locked data on 14 months ago because of COVID-related delays (total bs)?
- Or how they are prepping an article for publication (that was 14 months ago - where is it?)?
- Or how DCVax-L was approved for treatment in Switzerland (total lie)?
- Or how they used a press release to announce the hiring of Kevin Duffy with great fanfare about the all-important role he would play, but when he ditched the company seven months later they never said a word (no press release)?
- Or how they conducted an interim efficacy assessment in 2015, as they had said previously in a press release that they would, but never disclosed to shareholders that they had conducted the IA, never disclosed the results of the IA to shareholders, but saw trial enrollment halted by the FDA and then suddenly changed the whole focus of the trial away from the primary endpoint of PFS and toward the secondary endpoint of OS?
- Or how they allegedly officially changed the endpoints of the trial in 2020, at least for the European regulators (as discovered by someone who posts on iHub) but never disclosed it to shareholders, and still to this day have provided no explanation about what the actual endpoints are and why the endpoints remain unchanged in the USA under the FDA trial description?
- Or how they released an interim data report in 2018 that totally avoided any analysis of the trial's (then) primary endpoint?
- Or how they are right now, at this very moment, withholding material information from shareholders based on what they wrote in the very same press release cited above:

"As previously reported, the statisticians’ work is estimated to take a couple of weeks."

"When their computations are completed, the Company will receive the results of those computations and thereby become unblinded."

If the company is unblinded, as they say they are in the August 2020 press release, then where is the data? They said they locked the data in early October 2020, so according to their own words, they became unblinded "a couple of weeks" later. Right? It is now December 1, 2021. They have not released the data and we have not been given any updates - also as promised in the same press release. Are these the facts you are talking about?

Look, I could go on and on and on. There is so much more, and that doesn't even begin to touch on the fact that the company has had its hand slapped by the SEC more than once for inadequate reporting in its regulatory filings. Are these the facts you are talking about? Is this the evidence you are referring to in their PRs? Yeah, that's what I thought.

This company is a joke. It is run by liars, and they are running a scam. The financing deal they just completed with a usurious low-life scoundrel just bought them 8 more months with no TLD. That's what they did. They just raised enough money to pay of their previous debt obligation, and pay their $600,000 salaries, all while not releasing top line data!

How is it possible that after all the lies they've told, after all the misleading information they have put out, after all the false promises they have made and broken going back almost 20 years, that anyone could have the impression NWBO is "in the business of releasing facts, not speculation"? It's upside-down world. Astounding. It's just amazing.

Someone on here yesterday actually praised this financing deal as "non-dilutive", which is pretty indicative of the level of NWBO analysis we get. NWBO is literally at the bottom of the barrel if they are at the point where they have to borrow from John Fife. He's the only source who will still give them money so they can keep kicking the can down the road. That's all they are doing, and this deal bought them another 8 months of no TLD. A deal with John Fife is the clearest indicator in the world that your company is circling the drain.

Hey folks, here's a tip: this whole operation is nothing more than a scam. The company has known this trial is a failure for six years, and all they are doing is waiting on Sawston approval because that's all they've got left. So they keep playing the Ponzi scheme, engaging in a new toxic deal every few months to pay off the previous toxic deal, and to pay their $600,000 salaries. Do you not see that's what's happening?

Every press release they put out is a lie. In August 2020 they said they would release TLD in September 2020, and then they just pretended like that never happened. Do you not see that everything they tell us is a lie? Does anyone really believe that COVID is still an issue 14 months after alleged data lock? All of the excuses are a cover to keep you sucked in to their scheme. Why is the company refusing to release the data, even though they've been unblinded the whole time? I know enough about scientific analysis to say with confidence that if you gave me the right software, within 10 days of data lock I myself could have told you whether this trial met every one of the endpoints, and I bet the vast majority of you could do the same.

Is withholding material information from shareholders legal? Where is the data, Linda? This is not normal, ethical or right, and everybody knows they are hiding the data because it is bad. No company in history has ever sat on good data for more than a year with no end in sight. You are being lied to. Wake up! Snap out of it! You are the shareholders and this is your company! Hold these people accountable!

August 21, 2020 Press Release:

"The Company currently continues to anticipate reporting topline trial data in September, and anticipates providing further updates as the process progresses."

Since they didn't release TLD in September 2020, or in September 2021, it looks like the next best possibility for TLD is September 2022, at least according to this official press release of record they put out for the world to read. I guess we'll know when they provide further updates as promised in this August 2020 press release that they are yet to update as of Nov. 29, 2021.

Good grief, it's just amazing to me that people still think this company is actually about to release world-changing data on a cure for glioblastoma. What an epic joke! The people running this company are liars, and the information they put out is intentionally misleading in order to keep their base clinging to an increasingly desperate hope. They know that fools will believe anything as long as they think it will make them rich, so they put out false press releases and then allow their PR guy to manipulate sentiments through private conversations he knows will be relayed on message boards.

It's a shameless scam, because anyone with half a brain knows that if the data had been good they would have released it a long, long time ago - like years ago. But they didn't because they are sitting on a failed trial and are now withholding this material information from shareholders, and no one seems to care. They've been withholding this information since they conducted a secret efficacy IA in 2015 and never disclosed the results. And now they are just flat-out refusing to release data they've been unblinded to for at least 14 months.

What's most remarkable is that many of the shareholders don't even care. Any time someone points out the obvious facts that this company is operating a scam, there is a rapid and coordinated rush to defend the company and call these facts "short attacks". But there are no shorts here (well, maybe one or two). I am a long shareholder, and have been since 2013. I just want this scam to end, and I want the people who perpetrated it to be held accountable. Every Monday we come here and read about how this is the week, and how, 14 months after data lock, they are still putting the finishing touches on a publication, preparing for SNO, submitting final data to NICE, drafting a comprehensive update for the upcoming ASM, setting up the biggest booth ever for ASCO, hiring a new crew of custodians at Advent, all while working with FDA to change all sorts of policies and definitions so that it benefits NWBO and ensures the success of NWBO's Phase 3 trial for DCVax-L. It never changes, and it's all utter insanity.

Here is some advice for when this is all over and there is time to look back on it and reflect on what went wrong and what could have been done to stop this nonsense sooner. That advice is this: Don't trust people who lie to you.

Yes, it's that simple. People who lie to you once will lie to you again and again, and lying is often just part of those people's nature. Always remember that and it will serve you well, and, hopefully, help both you and me avoid ever again finding ourselves being manipulated for years by fraudsters.

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!