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No, actually it's just more lame excuse-making. I've read these posts for years about how NWBO is some maverick blazing a new trail, going where no one has gone before to do what no one thought could be done, and so therefore we should tolerate their unconventional methods and communications style.
Except none of it ever turns out to be true. The primary rules haven't changed and the game is still pretty simple. You run a valid trial, you lock the data and then release the data in short order, and if you've got the goods you submit a BLA and wait for approval. That's the script. If you are deviating from that process then it means only one thing - you don't have the goods. Everybody knows that if they had knockout data to share they would have done it by now and we wouldn't be sitting here five months after data lock wondering what the hell is going on.
You know, of course, that company has never said they are "waiting for a journal". That's just another lie/excuse that was made up here based on some alleged conversation with the suspiciously mysterious IR guy. Here is what the company has said publicly:
Yes, my post was agreeing with your interpretation. We don't know if the shares have been distributed yet, but they will be per the agreement. It's not a hypothetical as someone else has asserted. It is clear that CRL sees more value in unloading the shares in return for a discounted sale price, than they do in keeping the shares and paying a higher price. I wonder why that would be?
In any event, as you note, when we first learned that CRL had purchased Cognate, we were told over and over again that the sale was all about NWBO and the CRL's real interest wasn't Cognate's other clients at all, but was really that they just want to be a part of NWBO's allegedly bright future. We were told that CRL was paying a premium just have NWBO shares and have Cognate manufacturing DCVax. I stated at the time that there was no evidence this was true, and, in fact, it seemed more likely that the deal was not about NWBO at all but more about Cognate's other clients and growth potential. That was obvious from the revenue projections stated by CRL's CEO. Now we know that I was right. Oh, and you are right, too. You would have to be pretty deep in the pump game to read that clause and think it's just there to cover a hypothetical.
I also said that, just as with UCLA and Dr. Liau, it's not real clear that the relationship between NWBO and Cognate is very copacetic. The last we heard from Cognate, they had just settled a dispute over NWBO's sorry record of non-payment, and based on the language of their agreement we don't know for certain that the manufacturing contract is still even in place after January. It may be, but we don't know for certain and it clearly wasn't a consequential part of CRL's valuation of Cognate's revenue growth. That much we know.
Yeah, sure. I'm sure that's why they put that language there, just in case. It's a purely random and far-fetched hypothetical, not likely to happen in the least, but if it does . . .
You know your argument is a leaky bucket. You know that if they wanted to keep the shares, they would have written the language accordingly. But the truth, the reality, the actual fact, is that they don't want to keep the shares and so they have made provisions for how those shares will be redistributed and accounted for. Now, why would you argue otherwise? Is it just that it's something you don't want to happen and, therefore, you must always argue that which you don't want to happen must not be happening? It sure seems like it.
Now, we don't know if it has happened yet. In all probability it hasn't. But we do know it's going to happen. I'd wager $5K on it. Would you wager $5K that it won't?
I agree. Repayment starting November is interesting. That's the first thing that jumped out at me. I think this loan is a very positive sign. They've seen the data, and they still felt compelled to go out and borrow $11 million, which is more than their usual raise. But why are they still sitting on top line? Why not just put the top line out there so we can get the share price moving up and begin the process of getting re-listed on NASDAQ? That's the part the doesn't make sense to me.
I'm looking for top line on Monday or Tuesday.
Tomorrow will be five months since the data lock press release. Just curious at what point some of you will begin to say this isn't right. I don't know if it is or not, but I don't have a good feeling, and with every day that passes my optimism sags a bit more. I believe very strongly that if they were unblinded and the data was really good, we wouldn't be sitting here five months after data lock wondering what's going on.
For many years we have heard excuse after excuse for why NWBO does what it does. There were excuses for them not locking data last May. There were excuses for no TLD in June or July, and then September. And then there were excuses for why NWBO pulled its poster display and backed out of a scheduled conference (allegedly because they pre-scheduled a bunch of conferences thinking they might be ready but weren't. We were told there would be other conferences where we would see the same thing happen, but, of course, we never did).
So now we have excuses for why they have gone radio silent (quiet period!) and for why they are taking so long to release the top line after locking the data last October (waiting on publication!). Personally, I don't believe either of these excuses, but, I acknowledge they make perfectly fine explanations. My question is for how long? When do you folks, the ones making all the excuses, decide that, yeah, maybe there is a problem here? I detected that even sentiment_stocks had a waver in her tone yesterday, one that suggested this isn't going as planned.
So what is the threshold for you enthusiastic longs? Or is there one? Will we just move on to a new round of excuses as we always have in the past?
I agree for the most part. If the trial outright failed, I think it would be hard for them to keep quiet for five months, too. I mean, what's the point? My personal belief is that the data is not good and/or it has major issues with crossover, pseudoprogression or other validity aspects. It may be bad enough that they missed every endpoint (or what we think are the new endpoints), but that's unlikely. It probably hit on one or two. So what's taking all this time is that they are working backwards trying to sort out the confounding aspects of the trial, the validity issues with the data that got messed up by the way the trial was managed. I just don't think there's any way you can untangle validity issues after the fact. That's why I think they should have stopped the trial five years ago and started over. Maybe they have also found within the data some rays of light, i.e., subgroups that showed a strong reaction, and maybe they are also working on exploiting that.
One area where I strongly disagree is interim data. You are welcome to do your diligence as you please, but I would really, really caution you not to put too much stock into interim blinded and blended data. Interim data just doesn't have anything to do with final data because there's no accountability. Nine times out of 10, interim data from startup bio trials is going to make you say, "Wow, isn't that interesting!" There is a reason for that. In NWBO's case, there was a lot they left out related to PFS, and it doesn't factor any potential issues they are running into trying to extrapolate who crossed over and who pseudoprogressed. After telling us multiple times they were having the interim blinded and blended data published in a major scientific journal, they shopped it around for months and found no takers. At the last minute, they ended up buying space in a medical journal no one had ever heard of so that they could get it turned around quickly for ASCO.
The truth is, blinded and blended data has no value. It doesn't tell you anything except what the company wants you to think is happening. That data can be manipulated so easily, and to be honest, I don't trust the people running NWBO to watch my goldfish for an hour, so I really don't trust any interim data they put out for which they have no accountability. The whole "signed by 60 doctors!" thing doesn't mean what people think it means. Every time a doctor puts his/her name on a paper, they get professional credit, so why not add your name to a paper for which there is no accountability? I'm guessing maybe five or six of the doctors who signed actually read the whole paper. I honestly believe that.
In short, be very careful with how much faith you put into interim data. If figuring out successful biotech startups were that easy, well, . . . everybody would be doing it.
Is it correct that their last cash raise was in September 2020? If so, how in the world are they surviving? Presumably they cannot do another cash raise between data lock and TLD. That would seem to be at least some incentive for them to get this thing over with so they can get back to making toxic deals and diluting us.
When you call the front desk a nice lady still answers the phone. She told me they are still in business, and when I expressed my dismay at the company's inadequate communications she said, "Didn't you get the press release?" I assured her I did . . . back in October. I hope she is still getting her paycheck because I seriously wonder how they are managing to keep the lights on. Essentially all of their cash was encumbered back in the September 30 report, and presumably it's all been spent by now.
I just can't see this dragging on much longer. Something has got to give pretty soon.
You're one of the few here willing to admit the last possibility you cite, though you give it far too little credence. Everything this company has ever done points to that last possibility as being what is actually going on here. The people in charge have shown us over and over again. That is who they are. That is what they do. Over and over again. They disappoint.
But, hey, kudos to you for at least acknowledging it. There are so many here trying to blow smoke up our posteriors that it's hard to comprehend how and why they so easily overlook the obvious. They are not dumb people (with one or two possible exceptions), but for whatever reason they continue to miss the warning signs - the most obvious being that if NWBO had good news to share they wouldn't still be ensconced in a tomb of silence five months after data lock. They all know it, and yet they persist. It's willful negligence. They need a reality check.
I am not arguing that ATL-DC and DCVax are not the same thing. I never said they weren't. I believe they are the same scientific compound with different names. But the brand name DCVax is associated with the company NWBIO. There is a reason why UCLA was careful not to use that brand name in the official trial record, even though they used other brand names like Keytruda.
You can continue to claim they are using DCVax all you want. That doesn't make it true. That's not what it says on the official trial record, even in the space where they provide for alternate names. It's also not what the doctor said, even though you claimed she did. There is a reason why they do not use the name DCVax, and that reason is not the outlandish claim you made previously about them wanting to keep their association with NWBO under wraps because it's super duper top-secret.
As a newbie they won't let me post any more today, so I will just leave it at that.
Thank you for sending this because it proves my point. The quote that ATLnsider put in his post below is wrong.
No, see, you just don't tell the whole story. What you cite may be true, but it leaves out a huge glaring contrarian piece, which is that the official trial site says nothing about DCVax. You would rather rely on clearly biased hearsay and try to convince people of what you claim to be the overt truth all while denying that is what you are doing. Your pump scheme is going to be exposed one day, and I hope I have something to do with it because what you are doing is wrong.
Yes, that is one reference. However, when you go to the actual clinicaltrials.gov web site you will see that in the official trial description they go out of their way not to use the name DCVax. Even in the space where the web site provides an opportunity to list alternative names, UCLA provided multiple alternatives for Pembrolizumab, i.e., "Keytruda", but chose not to list DCVax. Instead they just used a generic term throughout. Isn't that interesting? Now why would they do that on the official trial designation?
I'm not surprised there are a few old references to DCVax on the Jonsson web site and in old PowerPoint slides, but there's no DCVax to be found in the official clinical trials record. Not a good indicator, in my book, since you insist on bringing it up.
link
Why are you spreading misinformation intentionally when you know the agreement expired on Jan. 17, 2021?
Seven years from the effective date was Jan. 17, 2021. That is when the agreement expired according to the language you quote below.
In all probability NWBO no longer has a contract with Cognate. It expired, and we've heard no indication it was renewed. That means that NWBO has no affiliation with Charles River, either. This kind of nonsense does nothing to serve proponents of NWBO and DCVax because it is nothing but unmerited hype. It is the same thing that has cost NWBO credibility for years because none of it ever turns out to be true. People see this nonsense and wonder why there are so many people telling lies about this little company, and then say, yeah, I think I'll take a pass.
It's fine to be optimistic about NWBO and DCVax, but a more measured approach that considers the facts at hand instead of wild speculation would do a lot more for building credibility. The last we heard from Cognate they were about to sue NWBO for failure to make payments and ended up negotiating a settlement that requires NWBO to pay $10 million when/if DCVax is ever approved. I think it is only right to put the optimistic view in perspective when making outlandish claims about NWBO having some kind of relationship with Charles River. It's possible, but at best a very long stretch. When the Charles River CEO talks about his high hopes for Cognate, he is not talking about NWBO. He is talking about the companies they already have under contract - companies that actually have products to manufacture.
I'm just tired of all the nonsense. It is long past time for the cards to be laid on the table.
The sale of Cognate has nothing to do with NWBO, as has been explained here multiple times. The CEO of Charles River estimated 25 percent annual revenue growth, which is entirely based on the companies Cognate already has under contract - companies that actually produce things - and that is what the sales price was based on. We don't even know if NWBO renewed its contract with NWBO, but we do know the last time we heard from Cognate they settled a dispute with NWBO over NWBO's unpaid bills and negotiated that NWBO must pay $10 million when/if DCVax is ever approved.
As for Flaskworks, NWBO paid $2 million and some change for the entire operation and technology. It's a two-person shop at Northeastern University. You would think that such a "game changing" technology would be worth a little more than $2 million, but maybe that's just me.
I'm not trying to be a fudster. I'm just pointing out obvious truths that should be part of any investor's due diligence. It might serve some well to take a more realistic view of what is happening (or, rather, not happening) here. I hope you are right, but with every day that passes I become more convinced you are not.
Seems like just another distraction to me. We don't know if the stock was part of the deal. Heck, we don't even know if NWBO still had a contract with Cognate when the deal was made, much less whether Charles River will keep a contact with NWBO. We've seen so many dots connected over the years that it looks like a Rorschach test, but we still don't know what the real picture is because NWBO still won't release the data and won't tell us anything except for statements that turn out to be lies.
What we do know is that the last we heard from Cognate, they settled a dispute with NWBO over NWBO's failure to make timely payments, and they negotiated a settlement whereby NWBO must pay $10 million when/if DCVax is ever approved. That anyone would suggest the purchase of Cognate is all about NWBO is beyond ridiculous. That's obvious from the growth numbers Charles River is projecting - growth numbers that can't possibly have anything to do with NWBO since FDA approval of DCVax is years in the future at best. The Charles River CEO's comments weren't about NWBO. They were about all of the other companies Cognate is doing business with - companies that have actual products to manufacture. Those companies are booming. Meanwhile, NWBO continues to do nothing.
Doesn't Merck have something to do with this Cognate deal? I mean they have to, right? Since Merck is ultimately behind everything happening with NWBO, they have to be behind this too, right? Just connect a few more dots for us and I'll be all in!
In all seriousness, there have been a lot of people who have left the employ of NWBO over the years. Pretty much all of them have gone on to bigger and better - and certainly more productive - careers. That most of them would remain in the bio tech field and that NWBO would eventually cross paths with them again at some point is not in the least surprising.
The sale of Cognate is a giant distraction. I don't believe it has anything to do with NWBO. Cognate is a company that has grown exponentially in the last few years precisely because it disconnected from NWBO (a deal that enriched the NWBO CEO but not NWBO's shareholders). Cognate is booming because of its contracts with companies that are not NWBO - i.e., companies that actually produce things. We don't know if Charles River will even keep the NWBO contract, but they would be fools to dump a contract that pays them a fee for doing nothing. To believe NWBO has anything to do with this deal seems quite a stretch - especially when some of us remember NWBO's last association with Cognate being the settlement of a dispute that almost led to a lawsuit. But, hey, keep dreaming and maybe one day your dream will come true.
For someone who has been doing this for three decades, he doesn't understand the first thing about corporate communications.
Dr. Bala, I think you have inadvertently put your finger on exactly the problem here. I've been following this trial as an NWBO investor for a long time, probably as long as only a few still remaining on this message board, and the single most credible deduction I have been able to make - reading between the lines of all the machinations, maneuverings, and language used by the company and affiliated scientists - is that there are profound problems with the trial itself.
We all believe in DCVax-L and we all believe it should be effective for at least some patients. But the purpose of a scientific trial is to prove that theory. In order for the results to be valid, the trial has to be set up and conducted properly and according to strict parameters. A trial that is not set up correctly or is not run correctly can fail even if the product being tested is inherently effective. There can be any number of reasons why a trial's results are invalid. The company's actions in changing the endpoints and using historical controls instead of the trial's own control group lend credence to the speculation that something is not quite right.
That doesn't mean that DCVax-L doesn't work, and would explain why UCLA is using it now in their own trial and it is still being used for compassionate use cases. But that doesn't help NWBO investors. There are some here who have suggested that what NWBO should have done is stop the trial some years ago and started over. I find myself leaning toward that camp lately. In reading this message board as a lurker for years, I have observed a serious disconnect among many of NWBO's most ardent proponents in how they point to interim data and isolated anecdotes of individuals benefiting from DCVax-L and then somehow jump to the conclusion that NWBO has therefore proved it works. That is not the case. They have yet to do so, and with every day that passes with no explanation of what is going on, it seems less and less likely that they ever will.
I am at wits end with this company and sold more than half of my shares a couple of weeks ago. It doesn't have anything to do with what I believe about DCVax. My beef is with the company that, regrettably, was tasked with proving its effectiveness. A company that locked data four and a half months ago should have made some kind of public announcement about top line data by now. That's the way it is done. I am just flabbergasted at how they continue to shoot themselves in the foot at every turn. It seems there is nothing they cannot mess up, and now they are messing up the release of the data by inferring, but not actually saying, that they are waiting for some kind of publication. Why? If the data is so good and can stand on its own, then they should have released the top line data and then begun working on a publication.
Long-time lurker, first-time poster. I bought about 8,000 shares eight years ago because I was excited about the science and I'd gotten a nice bonus that allowed me to purchase a few speculative stocks. I held on over the years down to $.14 and averaged down by adding another 70,000 shares along the way. A couple of weeks ago I sold 40,000 shares at $1.70 because I want to make sure I get at least something out of this. As someone who has followed this company pretty closely for eight years, I have to say the spot we are in right now is not very encouraging. I'm really not a fan of the way the management of NWBO treats its shareholders - disgusted really - and I think there are a lot of red flags right now that are seeming to confirm what a the naysayers have been warning us is coming. I just don't see how they can change the endpoints on a trial like that, right at the same time they lock the data. Doesn't look good, and I'd be surprised if the regulators just say hey, that's fine, you can make the endpoints whatever you like whenever you want.
This has smelled bad for a long time, but right now the stench is really strong. Hope I am wrong.