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X be nice, don’t laugh at me!
Am I miss reading the 10K then that Malik has 24,807 288 shares owned? It didn’t say options.
I think the defendants lawyers would love to know if this was true or not. If it was true, they’d have a hay day in court about it if the insiders were doing this sort of malicious stuff. It would essentially be a get out of jail, free card for the defendants.
I know, you’re right, however, even when we get news, like the last PR, which was very very good; nothing absolutely nothing except reduce on the price. So even news and milestones are meaningless for this thing.
Agreed Jester and probably psychotic, but when I did the math calculations, the math works for that analysis in terms of the amount of money one would need to cover their tax liability from interest income on their loaned out shares. Worked out very close but you’re right I’m probably psychotic. I’m just kind of wondering why someone would sell right beforethey submit for approval and why in the hell has the share price had absolutely no strength never ever no matter what the milestones and no matter what the company does.
Agree probably not the case but I’m also wondering what unbelievably powerful force is keeping the shares down. 24 million shares would keep it down if they were loaned out and shorted.
Question for the board. I’m wondering if insiders that own shares can have their shares in a brokerage account and allow them to be lent out and then they get interest income on the shares that are lent out to hedge funds who most likely short the stock. Is that something insiders can do? Legally? Does anyone know?
I’m wondering if the insider sale by Navid Malik was supposedly was due to a tax liability. But yet he didn’t sell any shares prior to that that would’ve given him a text liability, so how could he have any tax liability? Perhaps something else, I don’t know, but he certainly didn’t get any tax liability from holding NWBO stock.
I got thinking that maybe he needed to sell them in order to pay the tax liability on the interest that he made from his broker loaning out his 24 million shares to the shorts, mathematically, it turns out that that is approximately the amount of money he would need to cover taxes.
Just wondering, because I found it odd that an insider would sell right before the drug is submitted for approval; kind of weird isn’t it?
Any thoughts on this or do you think it’s crazy?
I’m just trying to figure out if management truly is on our side or not.
Just wondering if anyone has any insight why we’re just now starting to use GMP materials and hiring a consultant to use GMP materials. It seems to me that given the nature of this work, with cellular growth and treatment for patients one would’ve used GMP practices and materials from the very beginning instead of Now in the ninth inning saying oh, we have to hire somebody to do and make sure we’re doing GMP materials and methods. Any thoughts on this?
Just got today’s print version JAMA.
Interesting opinion, peace regarding CAR, T cell therapy. Turns out they found a rare instance in which pediatric patients who received CAR T developed a T cell lymphoma and the lymphoma in questions contained the CAR construct. This means that the drug product itself has transitioned into a malignancy.
Glad DC VAX doesn’t have to worry about that because it uses the patient’s own and cells. Just a little interesting sidenote.
Some chat poop on GMP!
When a biotech company is building a device to grow cells, the use of Good Manufacturing Practice (GMP) grade materials ensures that the products are consistently produced and controlled according to quality standards. It is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product.
GMP covers all aspects of the manufacturing process: defined manufacturing processes, validated critical manufacturing steps, suitable premises, equipment, materials and personnel, clear and detailed SOPs, instructions and records, and systematic reviews of batch and overall quality.
For a biotech company, the use of GMP grade materials in cell cultivation devices can provide several benefits:
1. **Consistent Quality**: GMP ensures that the materials used are of high quality and do not introduce contaminants that could affect cell growth.
2. **Regulatory Compliance**: Many regulatory bodies require the use of GMP grade materials in devices used for cell cultivation, especially if the cells are intended for therapeutic use.
3. **Risk Minimization**: Using GMP grade materials can help minimize risks associated with contamination, variability, and other issues that can compromise the integrity of the cell culture.
As for the cost, GMP grade materials are generally more expensive than regular materials, due to the rigorous quality control, testing, and documentation associated with their production. However, the increased cost should be weighed against the benefits of improved quality and compliance with regulatory requirements. The exact cost can vary widely based on the specific materials and their source.
It's also important to note that while initial costs for GMP grade materials can be higher, they can potentially save a company significant costs in the long run by reducing the risk of product recalls, regulatory fines, and damage to the company's reputation.
When a biotech company is building a device to grow cells, the use of Good Manufacturing Practice (GMP) grade materials ensures that the products are consistently produced and controlled according to quality standards. It is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product.
GMP covers all aspects of the manufacturing process: defined manufacturing processes, validated critical manufacturing steps, suitable premises, equipment, materials and personnel, clear and detailed SOPs, instructions and records, and systematic reviews of batch and overall quality.
For a biotech company, the use of GMP grade materials in cell cultivation devices can provide several benefits:
1. **Consistent Quality**: GMP ensures that the materials used are of high quality and do not introduce contaminants that could affect cell growth.
2. **Regulatory Compliance**: Many regulatory bodies require the use of GMP grade materials in devices used for cell cultivation, especially if the cells are intended for therapeutic use.
3. **Risk Minimization**: Using GMP grade materials can help minimize risks associated with contamination, variability, and other issues that can compromise the integrity of the cell culture.
As for the cost, GMP grade materials are generally more expensive than regular materials, due to the rigorous quality control, testing, and documentation associated with their production. However, the increased cost should be weighed against the benefits of improved quality and compliance with regulatory requirements. The exact cost can vary widely based on the specific materials and their source.
It's also important to note that while initial costs for GMP grade materials can be higher, they can potentially save a company significant costs in the long run by reducing the risk of product recalls, regulatory fines, and damage to the company's reputation.
Your comparison does highlight a key point about the difference between GMP grade materials and their non-GMP counterparts. In a hospital setting, products like a Q-tip would indeed be more expensive, not because they are fundamentally different from what you might buy at a drugstore, but because they must meet stringent quality control and documentation standards to ensure they are sterile, safe, and suitable for medical use.
It's not about "gaming the system," but rather about ensuring the highest standards of safety and efficacy. The additional cost of GMP products reflects the increased manufacturing, testing, and documentation efforts required to meet regulatory standards, which in turn helps to ensure patient safety.
The same principle applies in the biotech industry. GMP grade materials, such as cell culture media, are more expensive because they are manufactured under strict conditions that ensure their quality and safety, especially when the end product is intended for therapeutic use. To put it simply, the use of GMP grade materials reduces the risk of product failure, contamination, and potential harm to patients.
In the end, while GMP materials are indeed more costly, they provide a level of assurance that can be vital in sensitive environments like healthcare settings or biotech manufacturing facilities.
I don’t miss him. He can stay in his shell! Too much emotion.
But what about kosher bacon? Would they eat that?
Very nice AE. But I’m wondering if we’ll run into problems because I don’t think that there is that many time intervals where there wasn’t spoofing just saying.
Problem for us is that KG and his active managers have been trying to drive the price of our company stock to zero because apparently they must think that’s the Correct valuation! And they can’t be wrong, correct!! oh, OK now I understand.
From his own lab, and with his own experience from melanoma work. I think it’s great. It may definitely lead to something if it works. But it would require a trial of more than one in it.
OK did he really say that? He did not think DC VAX works? I think not. That’s why he’s looking at other immune therapies. He knows that immune therapy does work. He just wants to perhaps use a new way of achieving the efficacy of immunotherapy.
Nothing else new that is approved works!
Under?????? JAMA is not decent??
Not necessarily. He probably doesn’t have the secret sauce on how they develop DC VAX so was unable to have his lab develop it.
Also, it probably furthers the research in his own lab to try a new approach and that’s what he’s looking for. That’s perhaps more effective. Who knows. But I think it’s good that he’s looking at different things. But he is definitely not saying with this that DC VAX doesn’t work that’s a big overstatement in my opinion.
Well, crapo, iclight now I have egg on my face!
I just went back to the original protocol on the NCI website. Crap here’s what it said. I had this incorrect all these years in my brain.
The primary endpoint of the trial is PFS, i.e. time elapsed until disease progression, which could be either recurrence of the tumor or increase in size of residual tumor. Secondary endpoints of the trial are OS and parameters such as side effects, performance status and immune response. Of note in the trial PFS and OS times are estimated from time-point of randomization, which happens approximately three months after initial surgery, whereas in common clinical practice these are usually calculated from the time of surgery.
Also, I found this tidbit kind of interesting
Others have shown that DC-vaccination combines favorably with radiotherapy by increasing radio-sensitivity of tumor cells and up-regulating the expression of MHC antigens in animal models.27 In contrast, Chang et al.43 argue that the development of radiotherapy-induced mutant tumor cells, immunologically diverse from the ones obtained during surgery, may render vaccines inactive against residual or relapsed tumors.
Thanks, Senti
I just know from my own experience in dealing with these kind of tumors, that progression free survival is very dependent on the observer, measuring the tumor, the amount of contrast delivered at the time of the scan, and when the scan was taken in relative to when the contrast was placed in the IV so there’s lots and lots of variables that can adjust tumor size which is how they determine whether or not the disease progressed. Very very difficult in these type of tumors to ascertain correctly and with confidence.
Survival, however, is black-and-white either the person is alive or they are not. And you typically do have a date of death which leads to very good reviews and determination. So I don’t know why any of these trials utilize PFS in this disease.
This disease, typically in historically, has such a short overall survival that, even if you had an accurate determine progression, it would not really help you that much in terms of expediency and getting the data quicker to regulators.
Just wait for survival and that’s what our JAMA article has is a comparison of survival with external controls. That’s what makes it in my opinion so much more valuable. #DATA.
I just went back to some of my data sets all the way back to 2013 and 2015 and the primary endpoint for the DC VAX trial was always overall survival. Back in 2013 they had a competitor named IMUC which did a similar trial but only had five or six antigens that they targeted and it was presented and was a negative trial, and their primary endpoint was PFS
I was remembering at that time that I was thankful that the DC VAX trial had a primary endpoint of overall survival. So I don’t know why all these people are saying that the primary endpoint is PFS in the original trial when it wasn’t, what’s up with that I wonder?
These are supposed to be doctors that review data and don’t even know what the primary endpoint for the trial was? I’m sure they’re just copying what others have said and they were wrong. Unbelievable.
Thanks. The whole naked short thing is difficult for me to wrap my head around.
Meir. I totally agree, I think the data from JAMA should and I underline should be enough for approval.
However, we’re dealing with politics and money and regulatory agencies so you never know, I just remember what happened to DNDN and they had to do an entirely new trial.
Hope not, but if the combo is as good as has been presented, that will be additional data, unheard of survival data for this disease, which will help.
I’m just looking how those Harvard guys put an editorial in the SNO with Inaccuracy and got away with it
And I realize how intense people will fight against this.
It has been over three years since the data was locked. That’s gotta tell you something. Three years is a purposeful thing. Unbelievable in the length of time after data lock. And all the while patients are suffering.
I don’t know what you’re talking about …material?
If you read the book for blood and money, which was a very good review of some of the targeted agents. Some of their scientific advisory board members were able to do one of these applications in like less than a month, all by themselves, without any publisher or anything. Then again, they had very good compelling data.
Allit. I don’t know if you can enlighten me on how on earth the company would know that those holding naked shorts would have to pay this dividend because isn’t that the whole idea of naked shorts as you don’t have to pay interest, you don’t have to borrow and you don’t have to mess around with stock dividends. Because no one has any ability to prove that you have any naked, short positions. So I don’t know how that would work.
I think the delays may have been purposeful, because I think management may believe that the regulators will request a confirmatory trial, and NWBO wants to be able to say OK here you go. Here’s some combo data as a confirmation. And we’re getting close to having the combo data read out.
Senti
All nice. Ok We do two more months now to supposedly have a better submission only to have it still rejected twice just like OT and still take twice as long and as long as possible to get this drug submitted and approved. Remember this is NWBO we’re talking about, they have never done anything ever in the history of the companies universe on time or quickly!! So prepare, prepare to wait a long time for this.
Bio
Clearly, they did do their work. Their work was not about the medical literature or review of an article. They clearly did their work out, trying to discredit the data and NWBO!
That was the only purpose of the editorial not to help patients.
Wow. I wonder where Flipper gets the idea that it’ll just be a few months? I don’t get it.
Another chat Review. It does look like we won the oral arguments debate
The given text is an update on an ongoing lawsuit between Northwest Biotherapeutics (NWBO) and various market makers including Canaccord Genuity LLC, Citadel Securities LLC, G1 Execution Services LLC, GTS Securities LLC, Instinet LLC, Lime Trading Corp, and Virtu Financial (collectively referred to as "Defendants"). The lawsuit alleges these market makers engaged in 2,849 instances of spoofing NWBO's stock over five years.
Spoofing refers to placing large volumes of orders with the intention of creating a false sense of demand, then cancelling these orders once the stock price has been manipulated. NWBO alleges the defendants engaged in this behavior, affecting the value of its stock.
Recently, Magistrate Judge Stein heard oral arguments regarding the Defendants' Motion to Dismiss (MTD) NWBO's First Amended Complaint. The arguments were presented by William Burck, representing the defense, and Laura Posner, representing NWBO.
Key discussion points included whether the market behavior was normal or a wide-scale spoofing operation, the timeline of the alleged spoofing episodes, the effect of the supposed spoofing on share prices, cancellation of orders, whether the defendants were trading for themselves or on behalf of clients, and the motive behind the alleged spoofing.
Judge Stein frequently interrupted the Defense Counsel, questioning the arguments being presented. On the other hand, Plaintiff Counsel's arguments were largely supported by relevant authorities, and she was able to bring forth her points clearly and succinctly.
The text suggests that the oral argument went favorably for NWBO, although one exchange with the Plaintiff Counsel did cause some concern. The identity of the new judge initially worried the author, but their performance during the oral argument was deemed satisfactory. The case continues to unfold.
Thanks AE.
ChatGPT synopsis of what you posted.
The lead attorneys in the oral arguments presented compelling points in the NWBO v. Market Makers case.
First, the Defense Counsel, William Burck, argued that the plaintiffs were attempting to depict regular market activity as wide-scale spoofing, suggesting that the case revolves around mischaracterizing normal behavior by market makers. This argument attempts to downplay the severity of the alleged spoofing activities by framing them as standard market activities, thus questioning the legitimacy of the plaintiffs' claims.
On the other hand, the Plaintiff Counsel, Laura Posner, countered this by referencing similar cases where the defendants had conceded that the facts alleged were nearly identical to their own case. Posner specifically pointed out cases such as Harrington, Kessev Tov, and CP Stone, where the defendants acknowledged the similarity of facts. By highlighting these precedents, the Plaintiff Counsel aimed to demonstrate that the defendants' own previous admissions supported the legitimacy of the current allegations.
Furthermore, the Plaintiff Counsel squarely addressed the specific arguments made by the defendants regarding previous court decisions and discovery orders, emphasizing the relevance of those decisions to their case. By doing so, Posner sought to undermine the defendants' attempts to dismiss the case based on prior legal outcomes.
Overall, both lead attorneys presented contrasting viewpoints, with the Defense Counsel seeking to minimize the significance of the alleged spoofing activities, while the Plaintiff Counsel leveraged previous concessions by the defendants to support the legitimacy of their claims. These arguments set the stage for substantial legal deliberation regarding the nature of the market activities in question and their legal implications.
Thanks. Good stuff good stuff!
OK now in plain English.
The journal article CTIM-15 discusses the T cell response dynamics in Phase 3 glioblastoma patients who were immunized with autologous dendritic cells pulsed with autologous tumor cell lysate. The study found that immunization with these pulsed dendritic cells led to the expansion of new T cell clones and previously detected T cell clones in the patients. The research aims to understand the T cell response dynamics and their correlation with clinical outcomes. The article concludes that immunization with autologous dendritic cells pulsed with autologous tumor cell lysate induces broad spectrum immune responses in patients with glioblastoma.
As I recall, the primary endpoint for the original trial prior to any changes was overall survival. Not PFS. A prior trial using only four antigens from IMUC was negative on PFS back and I think 2013 or 2014. so I don’t know why everybody is making such a big deal about the PFS when it wasn’t even the primary endpoint of the original study. They’re like saying it is when it wasn’t. The significance of pseudo progression cannot be overstated, especially in those early years when things could get coded as progression when they really weren’t, that’s why overall survival is so important overall survival is the gold standard. Just my two cents.
Your post in rhyme,courtesy of chat, AI
Mother Powers, my life's foundation strong,
In your embrace, I find my belonging.
I drink the essence of your rose water,
Nourishing me with dreams to never falter.
Within your ambitions, I find my place,
A shareholder soldier, bound by your grace.
Crab legs, a feast, a cherished annual rite,
Symbolizing the bond that's pure and bright.
Through quiet periods, I learn to endure,
For in exchange, tomorrow's promise secure.
You hold the key to data and vaccine,
In Chinese-owned warehouses, unseen.
Help me open wide, face the OTC's might,
Knowing it devours, yet fuels my fight.
May my shares ever kiss your radiant face,
As we march together, embracing the pace.
Carry my weary body, almost spent,
Through space and time, with you I'm content.
You're my connection to wealth and enterprise,
Bound together, our spirits ever rise.
In salute, I honor your power and might,
Mother Powers, beacon of endless light.
Together we journey, forever entwined,
For I am yours, and you, dear Mother, are mine.
Or they’re thinking that it’s poised to go way up and they have a big prior short position and they want to prevent the stock from going up too too fast and too high. Then they’d be willing to pay it. In order to suppress the elevation.