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Quite so, the Q is written to describe the state of the business as of close of the quarter. I wasn't thinking about that - damn old age really does slowly rot the mind! I don't know how optimistic I'd be that the necessary inspections have been done in the meantime but there is a chance they are done or at least now underway. A positive finish in May sure would be sweet but I'm not going to be counting on it, just prepared for a very pleasant surprise (which it will be if approved, no matter how many weeks away that is).
I share your caution that this seems to indicate that MHRA is not going to be completing their total review process within a few weeks. I would have to imagine that the referenced statement was as of release of the 10-Q or possibly a short time before the release when the Q was being written. The inspections mentioned don't sound like they are related to the manufacturing facilities but rather a kind of audit by on-site inspection of main trial sites and possibly some other site(s) chosen at random to confirm by visiting and physically inspecting e.g. that all the documents and data referenced in the application are indeed preserved at the various trial sites. I would take this to be 'your application makes various claims, let's not just take your word for it, we need to actually go onsite and see for ourselves the preserved trial info' just to be sure there is no hanky-panky about the large amount of data that is claimed in the application. In as much as I would imagine this means a limited number or maybe even just one team from the agency traveling around to look-see multiple sites. If on-site visits have not yet even been scheduled as of today, even if the RA is super well-organized it's a stretch to think they will get it done before the end of this month. If the RA is quite organized it could get done by sometime in June. If not, well NWBO is completely at their mercy wrt their getting visits scheduled, coordinating with the sites to be visited etc.
I think this is a very clear warning that things seem to be going quite well in general, but there is still this non-trivial activity that still had not yet even been scheduled. NWBO has no control over how quickly those inspections get done, other than making sure that everybody to be visited is well prepared to have the visits concluded without any issues. It does seem like this is waving a red flag saying 'folks, don't expect the approval to get done by the end of May 'cause that clearly ain't gonna happen'.
Please explain why the Nature article says: "...Northwest Bioetherapeutics, Inc, which has licensed the DC vaccine technology". What does that mean if not that "NWBO holds a license for the DC vaccine technology used in the subject clinical trial"? That being the case how is UCLA going to be able to license it to anybody else who doesn't buy out NWBO's license?
Lol, "UCL", what does the 'CL' stand for, 'Cleveland'? But you know as little about biotech in general as you know of the world-class medical research centers like the University of California at Los Angeles.
For example, you don't realize that running full-scale phase 3 clinical trials to commercialize their research is not in their charter. Nor would any commercial company accept a partial license of university research that lets a pure research org like UCLA continue to develop a separate version of breakthrough technology and then sell the improved version to some other company. And why on earth do you think that UCLA's nature article would need to cite NWBO as the owner of the DC technology if that did not mean the technology described in the report? That would not make any sense at all. You know nothing about biotech, do you?
Nah, but you certainly might deserve a middle finger for failing to mention that the study you referenced is a meta-study limited to 5-year survivors. You compare the stats for only 5-year survivors to the Nature study's stats on all patients including those who failed to survive for 5 years. Any explanation of why you acted like you were making an apples-to-apples comparison? You could not have missed the statement of who the patient population was (my red coloring):
Methods
European Organization for Research and Treatment of Cancer (EORTC) 1419 (ETERNITY) is a registry study supported by the Brain Tumor Funders Collaborative in the US and the EORTC Brain Tumor Group. Patients with glioblastoma surviving at least 5 years from diagnosis were identified at 24 sites in Europe, US, and Australia...
Conclusions
Freedom from progression is a powerful predictor of overall survival in long-term survivors with glioblastoma. Patients without relapse often have MGMT promoter-unmethylated glioblastoma and may represent a distinct subtype of glioblastoma.
Flipper thanks for catching this stunning example of a bad-faith post! OP compared a study specifically limited to 5-year survivors to the Nature study to bash the Nature study results. Here in the US, we'd call this sort of chap a "liar, liar, pants on fire".
You bought the stock but you don't even know the sticker? Right, a very believable story NOT.
I didn't re-read their full statement but as I recall from memory, they were very clear that they had been trying out a few (maybe 4?) different prototypes but they settled on the one they plan to go with. This is clear because they say that after building GMP compliant version of the selected prototype their next step will be to use that finalized GMP compliant machine to collect the data needed to get RA approval for the device. The OP's quoteStates pretty clearly that the prototyping is completed. It's not even stated but clearly the only further 'development' work might come only if any unexpected issue with the validation runs requires any further tweaking (not expected but until they have the full dataset for approval in hand, the finalized prototype just might need some final tweeking.
Very interesting NWBO spoofing article link was posted here yesterday. here is the link to the article on substack.
https://bamboolounge.substack.com/p/update-the-spoofing-grift-on-wall
In the best possible interpretation, you filed an official beef and you are now here solely to be an attention whore.
BTW you mentioned that the UK RA has been considering DcVax for 5 months, yet the MAA was submitted only at end of December. How does that work?
Of course I have him/her on ignore. That one, in particular, has been and is going to keep posting 20-30 posts every day to 'flood the zone with shit' REGARDLESS of whether or not anybody replies. Without a doubt, they will dirty the msg board for newly potential interested investors, though they often say stuff that is so stupid that it's self-evident that they are not worth serious attention by anybody. Not that it matters but you are wrong when you write that any replies they get make them post any more than they would anyway. I think that is simply a fact.
Sure some fudsters likely get paid per response generated, but it's pretty clear that the subject poster in particular is straight up paid to post X number (like 25 or 30) of bashing posts every day regardless of whether or not anybody responds. I don't have the time or energy to read his garbage let alone respond more than once in a blue moon. But biosectinvestor is a lot smarter and bigger investor than I am and I understand why he makes a point of responding to a few posts every day or two, just to not concede the MB completely to these guys as far as what new visitors to the MB see. I don't know if he is right or not in being able to limit somewhat how much of a monopoly on the board this guy and his friends have on the basis of sheer daily volume of garbage posted. But I understand why he does bother to reply to a few posts.
Anyway this poster is gonna post his quota every day regardless of how many responses if any he generates. I'm sure you are wrong about the game the shorts are playing with this particular ID and probably a few others now too. They have gone even more than ever before into full shit-flooding mode now that we are so close to getting MHRA approval. I'm not sure if they are actually effective at all but I understand why biosect bothers to spend the time replying a little. And it seems obvious that at this point with some of these IDs they are going to keep up the same volume of posting regardless of how many responses they can get, that these IDs are certainly playing a different flavored game at this point. Again I don't care either way because I don't have the energy to read let alone reply to their nonsense.
The fact that you write this: "Are you saying Advent , with all the costs and expenses and staff of a legit manufacturing facility gets the shorter end of the stick" to NWBO? demonstrates a breathtaking width and depth of ignorance about the biotech (or for that matter, any manufacturing) business. It's hard to believe that anybody can write a word about biotech without understanding the basics of the business regarding who owns the IP and therefore stands to profit, so it may be that you do understand but are expecting your readers to be completely ignorant about the biotech business.
NWBO is structured the way it is, as an almost virtual company, using many expert contractors to do a lot of the most important work in trial and RA application strategy and execution. This was to get to where they are with the lowest possible expense. In hindsight perhaps it would have been cheaper and faster to build and pay directly a bigger payroll, but that is water under the bridge and the fact is that NWBO has raised and spent a small fortune to take DcVax this far, through a ph 3 clinical trial and RA application. NWBO owns the patents and all related IP - that is where all of the value is and that is why almost all the profits of commercial sales of DcVax go to NWBO. Advent's role is only to manufacture DcVax. They did not develop it. Advent owns nothing about DcVax that they can sell to any 3rd party. There was also considerable expense in developing and validating with the RA the manufacturing setup, which Advent did, however, that was 100% paid for by NWBO which is why NWBO owns all of the manufacturing process IP that they jointly developed.
This is biotech 101, even pre-101! A contract manufacturer doesn't somehow get ownership of the IP, short of buying out the developing company. The view you wrote on this, more than anything else you have claimed, is absurdly laughable. If you believe what you wrote it's so true what I wrote yesterday half in jest, that you know nothing, nothing about the biotech business.
If I'm really wrong, I stand corrected and apologize to you. It's been a long time, it dragged out for a long time to get it submitted and in my memory, I feel fairly sure that you had claimed 'longs should give up, they will never apply'. But your posts are amazingly prolific and I don't have a 'search posts for text string' feature available, so I have no way of even trying to search for that or similar text. That being the case I will grant that without an unreasonable effort I can't even try to refresh my memory on what you wrote, so though I won't admit I've got it all wrong on this, but I will drop my claim unless and until I find evidence to back it up. If other longs don't remember it the way I did, that would accept that as proof that I was mistaken.
I admit that in a long-running argument with multiple protagonists especially, it's easy to get confused about who said what and when. E.g. permabear A says 'they will never submit', could easily make me remember that as permabear B said they will never submit. Also, I assert that logically 'they will never publish the results' also would by definition mean they will never file for approval. I do think you insisted they would not get published PERIOD but again, without a decent text search feature it's impossible to search far back through a posters hundreds and hundreds of posts by reading one at a time.
Maybe I saw that. I'm guessing that he isn't going to go anywhere. I think that the shorts will are very likely to brazen it out and move to arguing 1. 'OK but what does MHRA know, whatever, the FDA is still never gonna approve. 2. until the pricing is decided and made public 'OK but the UK health service isn't going to pay enough to give any decent margins to NWBO' aka 'NICE will not pay for it at anywhere near the ask' 3. They will never get much penetration into the GBM patient population. 4. any other half-baked pasta arguments they can try to throw against the wall.
In other words, the FUD and MM pressures against the stock will continue (UNLESS wrt to the MM the suit goes to trial and the MM get forced or get wise enough under the legal threat to pull back). This time (i.e. approval by MHRA) will leave a mark on the shorts but we've seen them successful in pushing back like crazy against any gain. To be guaranteed that woh't happen again we need to have more good sized investors realize this Muricidel is going to become the SOC for GBM internationally fairly quickly, and as has been said by those who know more than I do, we need to get onto a better exchange where the larger inward money flows will be enabled. I'm not hugely confident that MHRA approval is going to be all we need for the stock to rebase up at a few bucks or better. It still seems more likely than not that the shorts will be die-hard until completely forced out. JMHO, I have no idea and will be waiting to see what happens.
Some prior sweeping claims of yours that proved wrong: 1. they will never get a credible peer-reviewed journal to publish on the study. 2. They will never submit dcVax-l to any RA.
Your next bit at bat here is nearly upon us, namely that "it will not be approved based on the P3 trial". If it does get approved by the MHRA will that third strike be enough to make you finally admit you don't have a clue? I'm guessing almost certainly not but it does seem reasonable to ask.
My post referenced a specific claim by FeMike from a specific conversation including an exchange he had with Thermo. Trying to understand my exchange with Mikey without understanding the antecedents is a fool's game. It's not my fault you are trying to play that game and jeez, you even presume to speak for Mike without having a clue of the prior exchanges. I asked Mike about that lie originally in October. Mike referenced that post of mine just a few weeks ago and at that time I reposted links to all the original conversations. Your assertion that Mike doesn't know what I wrote to him about is you talking for Mike when don't know shit about what the previous exchanges were, WTF are you talking about?
If you must know, Mike for some reason likes to rag on people like Thermo, which he did in October, saying that Thermo was taking advantage of retail traders. He claimed to know by intuition that Thermo sold shares into the very short-lived run above 1.00 in October. He specifically asked Thermo at the time and Thermo said no he didn't sell, in fact he was a buyer. About a week after that exchange as Mike continued to attack Thermo and he falsely claimed "I asked him if he had sold and he didn't answer - that proves that he sold". Which is a nonsensical argument even if it were true, but in fact, Thermo had answered Mike in the negative. But Mike then lied about that a week after that question had been asked and answered.
Alphapuppies posting like a jackass about Navid (both the form and his trying to make a very big deal out of Navid selling 2% of his position) was a different issue, completely orthogonal to Mike lying about Thermo. To accuse me of being confused and unexplained in arguments you have not been following at all is nonsense at best. If you feel you need to understand then please follow the thread back upstream or kindly mind your own business before passing judgment on a discussion you don't understand in the least.
Mike, you never did explain why you lied about Thermo. You claimed he never replied to your asking him if he sold when he had told you very clearly that he didn't sell. Why the lie? That's why I asked if you were senile - because you seem to be completely missing a short-term memory from one week to the next.
WRT to my harsh remarks to Alphapuppy, you need more discernment. Let me remind you of what Ralph Waldo Emerson wrote: "A foolish consistency is the hobgoblin of little minds". Calling all kinds of different posters "moron", completely at random is one thing. Calling a spade a spade is something very different. I mean responding to people who post trash-talking nonsense like the puppy did, climaxing with his pièce de résistance below.
(What I'm saying is that to me it's clear that there are reasonable opinions, opinions I disagree with, sometimes strongly, and then there is also deep BS, often posted in bad faith. Sadly, you can't distinguish the categories, but different strokes for different folks, as the original Maverick often wrote. Your attitude on this subject is clear so there is no need for any further discussion. However I would love to hear you explain why you lied about your exchange with Thermo).
Alphapuppy wrote:
Well surprise, surprise, suprise! Gah-lee, I guess you must remember that Gomer both got the girl in the end and also both outsmarted his Sgt. and got him demoted. As for Sgt. Shultz, it could well be a unisex role - it can be played by anybody with the right amount of deliberate ignorance. You seem to be very well qualified!
Did you used to act on the TV show "Hogan's Heros"? You'd be a great fit to play Sgt. Schultz. He was famous for repeating, "I know nothing, I know nothing".
NWBO needs a deal or deals that will bring them a lot of cash (and incidentally provide proof to the market of the value of NWBO's business, de facto by somebody paying them a large amount of upfront $ for certain rights and/or equity in NWBO). I don't understand your thinking about the potential supplier deals or your perennial favorite Eden leasing deals. How much would either supplier be willing and able to pay NWBO upfront? Are you saying they would buy the rights to sell Muricidel and make a very large advanced payment to NWBO for that? AFAIK that doesn't fit their business model as contract manufacturers.
Talk is very cheap. I agree 100% with Smitty - we've got precisely nothing WRT any flavor of partnership or buyout talks with anybody unless and until a deal is signed sealed and delivered. We don't know that NWBO has anything actually going on, and even if they were close to any deal - again there is zero guarantee of that - NWBO has nothing they can say that is worth anything to the stock until it's a "done deal". Short of that IMO longs would be very foolish to make any assumptions. Even if you qualify a partnership deal as "highly likely", we deserve and will get zero traction in the market for statements like "we are in talks".
I believe that we will get the MHRA approval and that Muricidel should end up as the new SOC for GBM. But how long it takes to get the approval is anybody's guess, and even when we get that, how long it takes to convince the market of how much that approval is worth is also an open question. Who knows what it will take to get the shorts to finally throw in the towel? That might not happen until after we get uplisted and who knows how long that will take? Some here may enjoy blue sky speculation but unless and until the concrete facts change, it's all purely speculation. At this point, arguing about projecting 'only' a $10B market cap seems silly because pps of even a few dollars would make me very comfortable.
Let's get MHRA approval plus NICE approval and see how much that is worth in terms of supporting the stock. We might still be a long way away from even a $10B valuation. At this point, I'd be very happy just to see the stock find firm support above $1.00 for starters.
Puppy wrote: "I have hit a cord with a lot of people who blindly follow management and think they’re perfect. Usually whenever I experience this it’s always because there’s an element of truth in what I say that people don’t like."
In other words, you post manure 'with an element of truth in [it]'. Then when people object to your nonsense you say 'those who object to what I say do so because they blindly follow management'.
Who was it that posted on here saying you were not a troll? You've just proved whomever that was to be an idiot.
Really well put! Excellent argument backed by some amazing statistics I had not been aware of though it had been pointed out to me that even a few months extension of survival has led to acceptance by the FDA.
Yes, I also read somebody coming to his defence. People do get frustrated, and some own shares then turn into completely obsessed haters. To me it's just hard to believe anybody whether long or short could believe the nonsense alphapuppy has been spouting. That's the biggest credibility gap - first and foremost he's been spouting really dumb shit.
LOL! Why the hell would the company ever respond to concern trolls like you? Most of what you are posting doesn't pass the smell test meaning that it doesn't make even a bit of sense. You make a nonsense claim and then use that to bitch bitch bitch about how horrible management is. One insider selling 2% of his holdings is NOT something that any experienced investors get their panties twisted over.
One more reason the claim you pulled out of your ass is dumb as anything: I'm not a lawyer but I think discovery goes both ways. That would mean that the defendant in the spoofing case can subpoena info from NWBO and anybody working for them, including stuff like whether any insiders loaned shares to shorter to short the stock. That would be the last thing in the world anybody associated with the company would want to have known if they would ever even dream of betraying the company's trust by loaning shares to shorts.
You are certainly playing the usual concern troll game: "I'm long but I'm very concerned about all the terrible stuff the company is doing to hurt us longs (and themselves too since they own shares too)". Otherwise, it's just no possible for me to believe anybody is dumb enough to post the nonsense you have been posting here. Who is that clueless?
Alphapuppy probably doesn't even know that insiders are very limited on when they can sell any shares (unless they have a plan in place and managed by a 3rd party that makes well regulated and very regular sales according to rules that cannot be broken). They can't sell any time near any financial report nor can they ever front run news. In the case the MAA submission was already announced and that very fact gave Malik the green light to sell because it was already well known that was coming. In other words that is precisely why he was free to sell when he did.
He has owned a very large position of shares for going on a decade. He sold just 2% of his holdings. Is that something to run around and shout or piss one's pants about? Of course not. When would the puppy want to let him sell any shares, never? After the MAA was submitted it would be too close to the quarterly/annual reports, and after those reports likely it becomes too close to a possible positive response from MHRA. This dynamic is obviously not understood by alphapuppy.
You come up with a half-baked idea that one Board member is stabbing the company in the back by aligning with the shorts via loaning them his shares. Then you demand that the company prove that didn't happen. In my book that makes you a nutter because there is no way in hell the company would ever have any need to reply to you. Oh btw I forgot to mention that one of your key pieces of evidence is that the member in question is/was in the finance business and according to you 'these financer types cannot be trusted, and a high percentage of them have major ethical problems.". That makes you a complete asshole willing and able to slander a whole class of business people.
The fact that you can imagine some garbage doesn't make it credible. That is how the shorts operate - make up nonsense at random, throw it against the MB and see who is foolish enough to pay attention to them. There are a lot of inexperienced and gullible retail investors out there, that is true. Also folks who are very frustrated and more than willing make up anything to find anybody specific to be angry at.
The burden is on you to investigate and learn how Malik got his shares to the extent that it's documented. Senti was correct - he brought Woodford to NW with investments both in the open market and directly from the company worth several hundred millions.I don't know how these things work but a finders fee of maybe up to 10% would not shock me at all.
Check out the latest proxy statement which shows he has 9M shares. It takes some work to reconcile the numbers. BTW you keep claiming what 'the numbers' show but I have not seen anywhere that you showed your work. You have no credibility with me when you make a wild claim and accusation without even showing your work to demonstrate exactly what you are talking about,. Without that as far as I'm concerned you are just being hysterical. And even if your numbers are good to claim what you do, it's nonsense to blame the stock, which has long been deeply suppressed for being hugely affected by a sale of %2 of one insider's position. That's trivial. You are just lashing out at random. Get a grip and own your stuff.
He doesn't have to respond to a nutcase making a ridiculous claim of 'maybe he did something' with zero proof (other than some math which you have never docu[t][/t]mented). It's that simple. Even if you had a serious case with some actual well documented evidence, you still don't have any standing to demand that he reply to you. Much less for a claim you more or less pulled out of your ass.
It's your right to post whatever theory you want to come up with on this MB, but have you no common sense at all?
What numbers? You are calling for the resignation or firing of a BoD member without even showing any work on your wild-ass claim. That's not what reasonable people do. IMO you are suffering from serious delusions of self-importance.
You are fixated on nonsense. I believe you or somebody else asserted that Navid owns 25M shares. I haven't seen any reference to that supposed "fact". FWIW the last proxy statement said he had 9M shares including options. Do you even bother reading the filings before you come up with supposed 'facts' which in fact are wrong?
Let's assume for the sake of argument that he owns 25M shares. Then 500k shares is 2% of his holdings. In my experience, an insider selling 2% of his holdings does not spook the shit out of a company's stock.
You've gotten fixated on something trivial to the extent of "demanding" that a board member be fired. I can guess that you are very frustrated with the PPS being this low after the MHRA submission. Can't blame you for that. But get hold of yourself. You seem to have lost your mind.
LOL. Pissant investor to BoD member: you need to open your personal financial books to the public because I assert that you might have been loaning your millions of shares to brokers for short sales for the interest $ you could have gotten. I'm just guessing you are a pissant alphapup, because nobody who really knows anything about investing would make such a ridiculous claim based on nothing other than "well he has X shares (btw you don't know how many are directly own shares and how many are warrants do you? If you think you do please explain how you know that [some MB dude said] so is the extent of your DD on this number, right? If not please explain how you documented it).
"With X shares he could have gotten Y dollars in interest payments if he loan his shares for Z length of time" - (btw please share your math on that too, nobody has any idea if your math even makes a tiny bit of sense). He sold $X worth of shares for a tax bill and we don't know what else he owns but he didn't sell any NWBO shares so OMG!!! maybe he had a tax bill for loaning his NWBO shares! So he has to disclose to the public what his tax bill was for. No dude, it doesn't work that way. This whole thing is you spouting random nonsense with nothing non-random to base your claim on.
I'm sorry to have to say this but you are full of shit. Like a BoD member is going to help the shorts by getting a few dollars to loan them his shares to short. Like anybody owes you any explanation to answer to a theory you pulled out of your ass based on pure wild ass speculation. Look, even if you're numbers are indeed reasonable which I seriously doubt you are totally nuts if you think that makes a case for trashing the guy let alone "demanding" that he prove to you that your wild-add and slanderous (I'm not saying that in the legal sense) guess is wrong
In computing the number of shares of common stock beneficially owned and the percentage of ownership of such person, we deemed to be outstanding all shares of Common Stock subject to options and warrants currently exercisable or convertible, or exercisable or convertible within 60 days of January 31,
Except for Powers most of the holdings of insiders are in the form of options. Cannot lend shares based on options ownership. You are way overthinking this in any case.
MHRA will approve DC-Vax. The soon-to-be-released UCLA combination study will show greater than 50% long-term survival of GBM patients. The FDA will not refuse to give GBP patients fantastic odds of conquering GBM because they are not criminally insane. The voices of the frontline oncologists and, above all else, the voices of the patients in the US will demand that the FDA approve DC-Vax. And they will. You can take that to the bank, and we will.
You guys are smart enough to understand this but you will never stop lying to get a paycheck. You dishonor yourselves every day.
He's doing what he gets paid for. Whatever his boss tells him to do. You might as well try to communicate with a robot.
They are only going to need a few dozen of these to start with, not exactly high quantity production. I'm not sure at all about the cost difference for the GMP level parts, but in any case you are quite right that at the prototyping stage why spend more for production level parts when the design is not yet cast in concrete. GMP also is about having all processes nailed down and documented with all t's crossed and that part also mitigates toward bringing in GMP expert consultants, I believe. Doesn't seem like it should be that big of a deal and indeed they haven't allocated too much time for it. But they do need to do final level very rigorous and well-documented testing as well with everything super well documented for an approval package and inspection.
I'm sorry for you, but DC-Vax will not cure stupidity.
I agree. It's good that they also gave us a near-term milestone to look for, so we can see how well things remain on track. Things should be getting a whole lot more real starting very soon and I sure hope that they manage to move with all urgency and also keep giving us increased visibility into the progress of key processes going forward.
Very nice comprehensive explanation, thanks!
I would just add as an aside that as long as they can make the timeline that you suggested, waiting for Eden to come online in commercial production will likely not slow down NWBO's commercial ramp-up because it's going to take some months for demand to exceed the current capacity of the facilities at Sawston for the manual process. BUT, the sooner they get MHRA marketing approval, the sooner Eden rollout moves into the critical path of their commercial growth. The teams know this and will be under a lot of pressure to get it done, I'm quite sure.