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I did not say you were against it, I said that would be a disastrous business for the company at this time and Flaskworks belongs to NWBO, not any other company, it is a competitive advantage. It is for dendritic cell manufacturing and this company currently has a huge lead in that area. Why would they accelerate lots of companies to compete with them in a high profit area with a low profit, easily copied product?
It’s a terrible business strategy. I get that you were an engineer and you seem to get more excited by machinery than the drug itself, but DCVax-L took decades to get through clinical trials. The company did not do all of that to then sell easily copied machinery at low margin and junk the dendritic cell cancer vaccine business.
CRL was bought for their capability manually manufacture. No way NWBO needs to sell or license their machines to companies to create competing products in dendritic cell vaccines. I completely differ with you on this and this is a drug company, not an OEM for medical products. you keep trying to turn them into an equipment manufacturing and licensing company, and that is a terrible business model and it would make the last 2 decades and investment a total waste of time since selling such equipment doesn’t require the same kind of clinical trials or proof to drug regulators that creating a drug/biological treatment and vaccine requires.
That would be an easily copied and low margin business with high capital costs.
Dude, this is a shorted to hell amazing breakthrough. It’s s/it’s like you who spend their entire years 24/7/365 posting here this kind of crap that says that is not the case.
UCLA to King’s College UK, Brown University to University of Pennsylvania that broke through with Car-T says you’re the scammer with multiple ID’s.
It’s not their job to amplify false rumors, whatever they may be. We know the fudsters and generally what they’ve been saying and implying daily. We’ll see what comes of it. I think they are simply saying that you can’t believe what you read on bulletin board from questionable sources and we all should know by now that everyone who posts on bulletin boards is generally not a reliable source, they’d not be chattering in such places, trying to figure things out if they were and had inside information. No one has inside information and generally all are merely speculating when they post. The problem is that some do claim otherwise and some use fear and anxiety to manipulate and often spreading such anxieties does not require a claim of actual knowledge, just the placing of anxiety is enough, unfortunately.
Yeah, it would be nice, but partners do not always put the deal on the table that you want until they see they might be missing an opportunity and right now, with the squeeze being put on, maybe even at someone connected’s insistence, they don’t have to feel any pressure.
The other reality that also is likely why you see so many personal attacks on key persons is that 1) they own and/or control through friendly hands, a substantial stake in the company; and 2) they are not pleading to sell. Buyers really do not like to pay a lot for opportunities like this if they think they can get a deal, so they Ben if interested, so long as they think they might get this cheap somehow, they can sit back and let the normal dynamics like dilution play out. Once dynamics change, then they may feel pressure or they may not. Depends on a lot of different factors.
We cannot know if they are having partnership conversations or interest expressed, but the squeeze can sometimes be a part of the dynamic even of some potentially interested parties trying to force a deal. The reality is, we just do not know. But those can be real dynamics.
We can only wait and see or move on. And then there are those who play games and manipulate to trade and squeeze value that way. The annoying ones.
So you say. The fact is, stocks like this tend to get squeezed and yeah, if people are constantly s/it talking, they are intentionally driving all buyers away. So if the only other activity is normal dilution, what you say is the actual intended result of the swing traders who sold their positions weeks or months ago and only talk s/it until they believe the decision is positive to buy back in.
I think you play naive here, if you do not know what is going on, but maybe you are really that naive…
Foogie, they are preparing to go commercial. The only way to pay those bills is dilution. If you did not know that, that’s just the reality of a pre-revenue bio. They could sell out cheap if that’s what you’d prefer. They are taking it all the way. The fact that the stock is going down hard now, is not solely because of dilution. The same dilution has been happening on an ongoing basis. But they have a single product. It is pending approval. Some investors squeeze stocks at this point in time while others take money off the table in anticipation of that squeeze and until the decision, up or down, by the regulator is certain. So a lot of the current squeeze just happens normally to stocks at this stage. But the fact is there are people who accentuate such movements with nonstop bashing at these moments and we see that too, and they purpose is to keep potential buyers away. That’s a dynamic intended to squeeze things as far as they will go, so that when the news hits, they hope to be the first back in and can get in as cheaply as possible.
So we’re just witnessing a lot of swing trading s/it talking going on.
No, your response was ridiculous. Nothing about that post assumed YOU agreed with me. This is just your spin. You spin to rationalize your s/it talking.
Hi Chiu, I honestly do not care if someone sells some shares and buys them back at set prices because they believe in cycles or certain patterns. I don’t do it but I have no problem with that. What these people do though is they then engage in activity to advance their anticipated profits by either s/it talking the stock down or changing a few weeks later and then claiming they are “longs” and believe in the stock and then the same people start to pump.
And when they do it, they literally drive investors away because of their bogus claims when they are talking the stock down. They do immense damage, for their short term manipulations. So i think that makes those people similar to vandals manipulating and over exhausting a resource.
That kind of bluster is amusing because the reality is, YOU have no idea. I don't either. But my response is at least rational.
It was not, for your own previous claims, GBM, but an infection.
Plus you have previously claimed that the reason you are here is that King’s College engaged in a giant scam. So now your post appears to say the opposite.
As I have said before, you behave as though you have a need for therapy after a brain injury, and unfortunately you act out in a fashion more akin to stalking and paranoia. Brain injuries do not necessarily affect the ability to communicate or talk, but they can affect other behaviors or cause a person to do odd things or even very bad or destructive things obsessively. In think you need counseling rather than harassing people here or at King’s College indirectly here.
So now, without saying so, just implying, you had a miracle cure of GBM without surgery and King’s College mistakenly diagnosed you as having GBM, try to make that convoluted nonsense make sense…
Agreed. A transaction like this, I think, suggests a desire to retain as many shares in friendly hands as possible rather than what shorts are suggesting, and to me, that means something entirely different than what they think…
It’s clear a board member and former board member took efforts to ensure that people did not spin what looks like a need for liquidity into some sort of statement about the company or timing, but shorts and swing traders love to do it anyway. Nothing new about that drama.
Appreciate the effort of the board member and former board member, and it retains a the apparent message, I expect, for those who hold and do not post for the purpose of increasing the volatility of price swings on the stock price, but of course you can’t stop the swingers from doing their thing and pretending they have everyone’s interest at heart by doing so. They are doing what they do to increase their profit opportunities.
Swing Traders driving away interest and capital is not mutually exclusive from a process that is constant for a pre-revenue company issuing shares as it does. Driving down the price, s/it posting helps accelerate the decline and pre-approval or pre-decision it is common for such persons to sell, and s/it post into the news so that they can get in cheaply. That’s just a reality that anyone can observe in many of these microcap bio stocks. It’s a regular pattern.
So yes, they are going to dilute in the lead up to going commercial but they’ve also been doing this in previous years as well, which is a necessity for pre-revenue companies like this, absent other means.
As I said. Swing traders. Here you are swinging it up and down and you’re on your tear it down binge. This has very little to do with approval, the ups and downs and the value of such a treatment. I did not say it prevents the volatile swings. This is why traders focus on stocks like this one, because they can be volatile and they can herd retail, which is basically what you and a few others do apparently, professionally.
Negative posting, they are already out. The need together it down for when they decide to get back and start pumping again.
Look, I don’t pump. I am not part of a “cult”. I recognize a valuable asset, but the swings in price have very little to do with long-term value, they have to do with how these traders post the short to midterm news prospects because this is a news driven stock until it has income and regular revenues.
Until that day, there is clearly a group who swing trade this as violently as possible up and down and play both sides, one week they are in the denouncing mood and another they are praising. They likely use multiple ID’s, as they clearly do on sites like Yahoo.
This is just the reality. Since they have decided approval is unlikely until the fall, most have likely dumped their shares and spend their days running down the stock as hard as possible so that when they get back in, they not only make up for transactions costs from selling (taxes) but also can multiply their money.
Anyone who knows the world knows this game. But you all are just too much about manipulation. You would not be here a/it posting every day all day, if you were not PLAYING the stock and retail, with negative posts.
I’m not here every day. I don’t tell people they have to buy or that approval is next week. I have speculated on the timeline a bit here or there, but generally, you can’t time these stocks. But clearly there is a busy crowd swing trading the crap out of the company and basically doing their best to rip off retail while pretending to be the “good guys” or the sane guys… but the reality is they are here to swing trade it, both ways.
Oh nonsense, there are clearly swing traders who enjoy running this up and down and make a lot of money doing so. That’s quite obvious. You would be here because it makes a lot of money for the traders.
Clearly swing traders are running this down as hard as possible so that they can get back in as cheaply as possible.
You are a fake patient. That’s the truth of it. You were never ever a part of this trial nor were you ever considered in truth, and you did not have GBM.
You seem to be replying for Theory… transparency is normal. Further, if you had a case, it would already be public and writing to regulators as you claim, you have already done so… your behavior and constant large level fibs make it unlikely that you are trustworthy in any sense of the word. Your desire to do harm to a company just because it has part of a trial using one of many hospitals, King’s College, which you apparently hate, and thus your desire to do harm to many people beyond, on a daily basis nonstop, as I have said, makes you far more like a sociopath than a person who means well.
Please get help.
Thank you ID. You be well! Fingers crossed for a positive burst of news soon from regulators and commercial partners.
I am perfectly happy. You take care of you. You’re the one wasting days here for reasons that can only be explained as sociopathic reasons.
I think giving away or even leasing the Flaskworks technology at this time, would not be in anyone’s interest, other than the CDMO’s and potential competitors. It’s core technology and I certainly hope, despite the constant claims by shareholders, that they have no intention, any time soon of throwing their core technology and new advantage out there for others to leverage and instantly catch up.
CRL would need to compete. I see no specific advantage they have other than that they have facilities, which they would charge handsomely to use. Sawston can deliver globally and can be developed quickly for Flaskworks, and CRL’s facilities are full cleanroom compliant, therefore more expensive. To make them less compliant is a modification, and not likely ideal on a cost basis.
I know people want to think somehow CRL offers some advantage because it is a publicly listed, not insubstantial firm, but most ideas other than straight CDMO are bizarre and unlikely, and the CDMO idea requires a kind of flexibility unlikely in these circumstances without a large, up front payment of many millions of dollars. The company could finance that and have an asset in a factory and entrust advent to send personnel to set it up. Or do the same itself if it ever decides to do it that way. I see no real advantage to re-engaging CRL except in a stop-gap way immediately meet demand with manual manufacture until a Flaskworks facility can be set-up nearer and faster by NWBO at that time. As a real estate and manufacturing facility, such deals can be done with debt and appropriate financing once the revenues are there.
Other drugs that have been much more expensive with nowhere near the potential benefit have been approved. They will weigh many factors, not just the price. Price is important but given the core measurements for survival including recent data in the comparison, it is doubtful they would want to be seen to be withholding this from patients.
And on an ongoing basis, treatments at a doctors office not the hospital, virtually no side-effects and none that require hospital treatment, low maintenance, the cost monthly is not just competitive with treatments that are given frequently in the hospital with terrible side-effects that require additional care, but it is substantially less, with way better quality of life and providing a substantial survival benefit that looks likely to grow immensely with poly-ICLC and other potential combinations.
Nothing you write is the law or even a regulation. Guidance I have shared with you repeatedly, is not the same as a hard rule or even regulation. The FDA uses it only as a “guide”.
They do give reasons and if you talk with a regulator and come up with a meaningful and excellent way to address the issue any guideline is intended to address, they tend to have an open mind if the result is a benefit to the public and to everyone involved, which is the case here.
In a previous post I explained how that worked with the ECA. The regulator has a mission to reform from formalistic ideas that are not only impractical, but delay cures and beneficial treatments from reaching the market just because someone in 1950 thought rigid formalism in such studies was the way to go. They know better, hence the approval to change the trials measure to its secondary measure, and to allow the ECA when the regulator had imposed a crossover to address issues of ethics. The ethics issue is actually addressed in their article in the subject of ECA’s by the head of the division that will make this decision, specifically in the case of deadly disease like brain tumors. They actually said it out loud. But shorts cannot hear or read when their interests are contradicted by a regulator.
Hence also Congress charged them to reform in the 20th Century Cures Act, and they have various, well known efforts to effectively transform these processes and maintain an open process that focuses on results, not on false notions of process that get in the way and delay cures.
So, yes, NWBO used a blinded, external, expertized firm to create that ECA, and there were literally no other trials to look at than the ones they considered statistically and, as blinded experts, “prospectively”. They looked at all the most appropriate and best run such trials that had control arms like this one, then they did immense and careful statistical analysis to ensure they were not just comparable, but that the results had very, very little potential for any difference whatsoever when the results were applied after the fact, after they had created their ECA model. They went far beyond what would typically be done prospectively and statistically, typically, and yes, because they could, and this was done by experts in epidemiology and statistics at University of Chicago that swore by affidavit that they were blinded, that they only looked at the prospective trial protocol and these other trials as well, and then upon unblinding, they applied the ECA they had created. This was all done before unblinding. Therefore, the requirement to avoid a biased, retrospective ECA was met. However, I will point out also, regardless of the rigidity you suggest, the FDA often not only allows, but even invites and approves drugs that do, in fact, retrospectively look back. If you read Adam Feuerstein, supposedly that is a no no, but the reality is, they frequently do things that shorts and shirt writers insist, not only doesn’t happen, but that they do not complain about because that would highlight how frequently they lie.
Further, the FDA has approved drugs for cancer and for brain tumors that are far inferior to this one with far more flawed data for even brain tumors, simply out of a concern that there be options to manage symptoms and improve quality of life, which was a result here for virtually all patients. This is the first trial in many decades to show a systemic drug that creates a survival benefit on its own, and when used with a stimulant, can almost completely change the nature of the disease for a large percentage of patients. And this drug does all of that while also improving quality of life and though it is all made up front, on a monthly basis, over the time of likely survival the cost is comparable or less than competing drugs when they launched, and n most cases substantially.
A regulator would NEVER ignore those things as you do. Never.
You, on the other hand, can write on bulletin boards, social media and maybe even articles for publication. But it won’t change the facts at the end of the final day, and that is all that counts.
Previous post:
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=174821424
Rather than posting a “question” as if you’re saying something. Understanding the laws of the UK, on falsely accusing someone of wrongdoing, as I am sure you do understand, I would ask you to go ahead and lay out your full and complete case, with evidence here for all of us to hear exactly what you’ve got. Please, go ahead. Lay out the facts. Surely you know that truth is an absolute defense to defamation. So feel free to lay out the truth for us.
I will point out that this website IS in fact created by a UK company, and you are in fact writing about a UK company, Advent, its ownership and claims that somehow it is involved in some sort of behavior which you suggest is not above board with NWBO and its CEO. Please go ahead and lay out the case, also please Nemesis and Learning Curve, you all are involved in this claim, so lay it out for us.
No, it has IP, and contracts and is a development stage company. All of the IP and rights belong to NWBO. Cognate is a contractor and yes, the payroll for certain craft work and expertise is contracted out to Cognate to handle. But the knowledge and expertise is not at the CDMO, it belongs to NWBO and gets transferred on sales.
You all play it like you are the most ridiculously inept and unaware people to convince, I suppose, retail, that something other than what is happening, is happening. But the baseline for all of this is patent and IP ownership and contract rights. And you guys play it stupid I suppose to convince people you presume are stupid, that you’re saying something “sophisticated”… but the reality is, you’re just being stupid. If there were any truth to your claims we know full well there would be lawsuits and claims with regulatory bodies, and you literally have absolutely nothing, nada, zero. Your claims are zeros. You guys are zeros. You make money spreading lies and misinformation, which means your wealth is based on lies, misinformation and zeros. Of course every good lie, requires a baseline fact that is real, that can be dressed up to appear to be something else. And that’s what you do.
No, Advent did the work for Europe and was a subsidiary of Cognate, so everything Cognate had, came along to advent as part of that deal. You guys are quite dense.
The private equity fund she had took that part instead of a cash payout on the acquisition of Cognate, but you keep trying to manufacture nonsense without any proof or basis, which, if you had it would have long ago been with the regulators or SEC. You only can say and speculate on social media because what you say is total BS. Nothing there.
I am not trying to convince you fools of anything. That would be a waste of time. Your income depends on being completely focused on making certain arguments regardless of the sense or meaning of them.
You have to pay companies to do that work. CRL is a large company with resources of its own. It is not currently doing any work for NWBO and to contract with it will, I promise you, cost many, many millions up front before any work is then billed on a project by project or output by output basis because they have to staff that project and they will not do it efficiently or cheaply because they are not a start-up and you’re competing for their resources with larger and better funded other companies.
But yeah, you have to pay for such services. Is this new information for you? Advent remained under the original contract asap subsidiary, and had the data transferred and handy, and they were doing the work ON SITE, something an established CDMO is not going to like, and if they do it they might even charge extra for it, a lot extra, because they will be staffing people overseas. That means expat comp.
There are many reasons why it worked out and was convenient and symbiotic in ways that would never have worked with a CRL. Never. But yeah, you keep fantasizing about how this is such a terrible deal. I’ll think about the other companies I have known that have spent tens of millions of dollars working with other kinds of CDMO’s who do not do this work, but did other kinds of deals and how getting even started with them took extra years to get going sometimes. Meanwhile you can keep making up stuff.
They are not a drug company. So they only use they would have for Flaskworks in the context you describe Gary, and this is a fact, would be to create competitive products. Drug companies have particular frameworks. CRL is not at all like any of those companies and they have no intention to become a drug / bio pharmaceutical marketing company.
Quit it with your fakery. They are in fact a contractor and not amount of noise says otherwise. The fact is, the work in dendritic cells is not and was not a common thing. Advent is an offshoot of Cognate which she was able to preserve when they were bought by CRL, this bringing along that knowledge and expertise to set-up and maintain the data and knowledge and details from that trial and bring it along to Sawston to set the factory up. It’s was an amazing coup. And shorts hate that and must turn everything good into some form of false putridness because that is your job: misinformation and disinformation. Same tactics used in politics, turn your enemies’ strongest advantage into an apparent disadvantage to people who do not know better.
The guidance it has been quoted to you is not fixed, it does not have the power of regulation, it is purely guidance and FDA does things not consistent with Guidance all the time as it explores new ways of doing things.
The relevant issue there, in what you repeatedly claim is fatal, is BIAS, and if you address bias by other means, the regulator very likely will take those efforts completely under consideration and I expect the company was in complete consultation as they did take such steps. I would not expect your formalism to be their primary concern.
In the JAMA paper ancillary docs they provide details about the external control trial arm and how it was developed. A completely blinded, expertized epidemiological and statistical consulting firm was hired on a completely blinded basis. They know GBM, they know the parameters of this trial and all the trials that were in the industry. No additional information was provided to them and they have provided affidavits to that effect with their report. They remained blinded to the trial as though it had not begun and their advice was prospective in the development of their ECA tool. Then they did statistical analysis once the trial was unblinded to validate their work. They went far beyond the normal statistical analysis that would be presented to do that analysis and present proof that their method was valid.
They were the ones that created and measured that ECA and did external additional statistical analysis to validate it in ways far beyond the basic techniques of traditional analysis.
The FDA is charged with getting cures to market, faster than they have traditionally. That is the purpose of their reforms going on still, and the 20th Century Cures Act.
You repeat notions as if they are stuck in the 1950s and make them seem like contemporary regulation, and I get it. Competitors want their rivals to be stuck in the 1950s or at least for it to seem like they will be, while they sell their outdated drugs. That is the nature of the marketplace.
But the reality is, the market and the regulator are not going back and they are not going to waste the efforts and sacrifices of patients on the alter of formalism when the results are learned and powerfully validated right before them and patients and doctors are crying out for some more effort to advance a stagnant field of medicine in brain tumors with drugs that technically could already be available to patients and extending their lives and improving their quality of life substantially. They have no guaranty that other promising trials, as we have seen before will result in the same results provided here if outstanding survival data, both from the phase 3 and also compassionate use and side trials like the combination trial and trial with poly-ICLC.
It would be way out of the range of norms for that to happen, though I do believe they will kick the tires and possibly make some noise to satisfy the formalist/traditionalists who are just voices for their own treatments yet to be proven. That’s part of the dance they all take to affirm the old guard while moving the science and technique of accelerating the science forward.
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Guidance:
The guidance docs are often a work in progress and the FDA approves drugs with virtually zero proof of benefit quite frequently and to their shame, because there is a need and they know not much else is out there, for diseases like cancers, and especially rare diseases.
This one has incredible, credible proof from major researchers that are highly respected at top research universities worldwide. Looks like the UK will also validate it.
That’s a huge positive. Despite claims otherwise.
And Flaskworks technology is all owned by NWBO. The CDMO is just a normal contractor but this one has the skills developed during the trial to ensure continuity through the approval process, get everything up and running commercially, maintain all the necessary records for approval of DCVax-L, externalize certain costs until the company is commercial and a symbiotic tool to keep the factory running with outside products, as facilitated by the local development authority, which allows the facility to some degree to earn while it would otherwise be fallow, awaiting approval, all the risks and costs externalized for that to the CDMO, while the facility serves, for now, as a local
Industry development center. All of that is very positive and CDMO relationships across this industry are normalized by basic and standard contracts of which this is one and it can be terminated whenever that becomes appropriate, all of the IP and true value at NWBO.
But hey, make up stories. That’s what you do.
True. He’s blowing up.
Exactly. His nonsense is about justifying his wicked behavior, not about helping or protecting anyone. All of that is just narcissistic / sociopathic crap such people tell themselves.
Citron is a very famous short. One of the most well known.
He’s here for his own purposes and they have nothing to do with protecting anyone. He’s just destructive and the story he tells is the lie he tells himself not to deal with his bad behavior. Even sociopaths think they are the good guys. No one thinks they are the bad ones.
Drugs don’t get franchised, but as I mentioned, licensing for specific diseases or for a given geography, is another matter and might be what you mean. We’ll see what they do. At this time it’s all speculation, of course.