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Oh nonsense. More of the "fraud" claims when shorts have nothing rational to say anymore.
Alter Egos: https://investorshub.advfn.com/boards/profile.aspx?user=532500
There is no such discussion. Shorts raise it to scare away investors.
So the first video you put there is heavily edited and false information presented initially as if it's true and as if it's really him saying these things, and it's NOT. Those videos are like propagandistic programming. Like something they would put the soldiers in front of in Manchurian candidate or something.
The 2nd video is Russel Brand, not a great source for information, but I realize there is a whole culture out there that embraces alternative sources of information. But that video also opens like a propaganda video, pretending to be funny. Repurposed content no doubt, but the sources of such video are unknown when it is presented in that fashion. People think he produced it and most likely he didn't. It's propaganda. It's not scientific. It is meant to induce an emotional response, a kind of disgusted humor that spreads and makes people stop listening to actual science.
Personal stories are not a way to validate the safety of a vaccine. More people than likely for any vaccine in our lifetimes got the COVID vaccine all at the same time WHILE we were suffering from a very mysterious pandemic COVID disease that constantly created strange symptoms. During the pandemic, even before the vaccines, people had heart problems, skin rashes, eye issues, and digestive problems as well as causing people to have their limbs amputated because of complex effects on blood circulation. Each variation of COVID that comes out seems to create new symptoms or have symptoms that before only affected a few people become the dominate new symptom. However, the severe disease and hospitalization have been almost entirely stopped because of the vaccines.
If one were to go on personal stories, virtually everyone I know got the vaccine, some only hesitantly, with no negative side effects that have been discussed in any fashion to suggest that my friends and acquaintances became anti-vax because of it. Virtually all of them are getting the boosters as well. I have had covid a few times, and after I have it, I get long COVID symptoms that mostly clear up, but they are peculiar and they make post covid worse than actually having COVID. In that context, if I were one for this misinformation and if my COVID had been asymptomatic, I'd probably blame things happening on the vaccines. But it wasn't the vaccines, it was the COVID. And multiple times now, when I have gotten the vaccine, my odd post covid symptoms often clear up. The reality is that personal stories don't vet vaccines. People can have had or still get COVID, and not even know it, and blame the vaccine for COVID symptoms or long-covid reminders that may strike possibly after having an asymptomatic COVID. Also, people can have psychosomatic responses because they have been convinced the vaccine will harm them. For instance, rashes are often induced by stress. These symptoms can also be autoimmune responses and one of the reasons COVID is so bad is because 1) many people get it without ever knowing they even have it, and spread it; and 2) it really causes the most damage and even kills people because of the autoimmune response.
So there are bound to be a lot of strange situations that people can't explain. Many have been made paranoid by online content that is promoted with no actual scientific basis. But if you don't want to be vaccinated, no problem. But people spreading false and non-scientific information is obviously going to be met with people responding with scientific information.
I guess when people can't win the argument on substance, they turn to that kind of emotional propaganda to do the job for them.
You did not post any court order or court document. You just posted an available document about Pfizer's adverse events which they provided and implied it was only released on court order and was sealed for 75 years by the courts, meaning it is unavailable. Yet there you have it. I put in your previous complete post, not this shortened one, and ChatGPT answered below. I know you said you don't trust media but you do trust AI.
I inserted your complete previous post before it was partially deleted and asked ChatGPT to analyze it:
This person has posted this on a biotech chat board and I would like to address the comment, whether truthful or not truthful, respectfully. Can you address the factual points one by one with as much specificity as possible. Address it both as an expert in public health and regulatory medicine as well with legal and scientific precision:
PFIZER UNDER OATH SAID IT CONDUCTED FRAUDULENT TRIALS, ADMITTED THAT ITS VACCINES WERE NOT SAFE AND EFFECTIVE. YOU THINK THE JUDGE/ PFIZER/OR THEIR LEGAL REPRESENTATIVE NEEDS HELP FROM SOURCES TO FACT CHECK WHATS ON THE COURT DOCKETS?
PFIZER'S COUNCEL, WHO WAS ACTUALLY AN FDA EMPLOYEE 🤔: "PLEASE JUDGE DISMISS THIS CASE, WE (PFIZER) DID NOT COMMIT FRAUD, WE DELIVERED THE FRAUD THAT THE GOV'T ORDERED!)
THERE'S NO PATH TO OVERCOME THIS REALITY”"
Based on the document you provided and the context of post-marketing surveillance, there is no data suggesting that the original post on the biotech chat board is accurate. Let's address the claims made in the post:
Pfizer Under Oath About Fraudulent Trials: There is no evidence in the document you provided, or from credible sources, indicating that Pfizer has admitted under oath to conducting fraudulent trials. The clinical trials for the Pfizer-BioNTech COVID-19 vaccine were conducted according to international standards for safety and efficacy and were peer-reviewed. Regulatory bodies like the FDA and EMA reviewed these trials before granting emergency use authorization or approval.
Admission of Vaccine Being Not Safe and Effective: The document does not contain any admission by Pfizer that its COVID-19 vaccine is not safe and effective. Instead, it lists adverse event reports, which are a standard part of post-marketing surveillance for all vaccines and drugs. These reports alone cannot be used to determine vaccine safety and efficacy without a thorough scientific analysis to establish causality.
Fact-Checking Court Dockets: The claim about needing external sources to fact-check what's on court dockets is misleading. Court dockets are public records, and significant legal admissions would be documented in these records and covered by credible news sources and regulatory bodies.
Pfizer's Counsel Alleged Statement: The statement attributed to Pfizer's counsel in the post, claiming they admitted to delivering "the fraud that the government ordered," is not supported by any evidence from the document or other credible sources. Such a claim, if true, would be a major legal and ethical violation and would likely result in significant legal consequences and public disclosure.
Claim of No Path to Overcome: The assertion that there is "no path to overcome this reality" is based on the preceding unfounded claims. Since the initial claims are not supported by evidence, this conclusion is also unsubstantiated.
In summary, the document you provided does not support the claims made in the post on the biotech chat board. The document is a standard report of post-marketing surveillance data, which is a routine part of monitoring the safety of any approved pharmaceutical product. It is crucial to approach such claims with a critical eye and rely on verified information from reputable sources.
The document you uploaded is a scan of a Pfizer report, specifically an "Appendix 2.2: Cumulative and Interval Summary Tabulation of Serious and Non-Serious Adverse Reactions from Post-Marketing Data Sources" for the BNT162B2 vaccine (Pfizer-BioNTech COVID-19 vaccine). This document lists various adverse events reported during the specified period.
It's important to understand the context and implications of such a document:
Adverse Event Reporting: Adverse event reports do not necessarily mean that the event was caused by the vaccine. They are reports of any health problem that occurs after vaccination, regardless of whether it's believed to be caused by the vaccine. This is part of the safety monitoring process.
Post-Marketing Surveillance: After a vaccine is authorized or approved, ongoing monitoring (post-marketing surveillance) is conducted to detect any rare or long-term adverse events. This surveillance is crucial for maintaining vaccine safety.
Interpretation of Data: The interpretation of such data requires expertise in epidemiology and biostatistics to determine if there is a causal link between the vaccine and reported events. A mere listing of adverse events does not establish causality.
High Number of Vaccinations: Given the widespread use of the Pfizer-BioNTech COVID-19 vaccine, the absolute number of adverse event reports will be high. This must be contextualized with the number of doses administered.
Regulatory Review: Regulatory agencies like the FDA and EMA continuously review post-marketing data. If a causal link between an adverse event and the vaccine is established, they will take appropriate action, such as updating recommendations or issuing warnings.
Public Access to Information: Making such data publicly accessible is part of the transparency process. It allows for independent review and analysis by experts in the field.
In summary, while the document provides data on reported adverse events, it does not imply that Pfizer admitted to conducting fraudulent trials or that the vaccine is unsafe. The interpretation of adverse event data requires careful analysis to understand its implications for vaccine safety.
You really would not likely want to see the ChatGPT fact check on this post of yours. I will spare you.
Thanks abeta. Did not mean to make it sound so strong. But it helps the argument. :) I am not trying to say it is already approved though. I do think the UK regulator is very positively disposed. But they will look at the full package, wrinkles and all, rare disease, amazing results, challenging new ways of looking at the data that are positive but unconventional, and they will no doubt have eminent people of many perspectives doing so and, as I have always said, they will be "kicking the tires", which is their job. I believe in the end, given past decisions about other treatments that are nowhere near as promising, they will have no choice but to approve. But that's just my lowly opinion. I can't predict the future or outcomes. I simply have come to believe it. And everyone should look at the facts and doe their due diligence and figure out what they believe too, wherever that research leads them.
Because you trust ChatGPT, I have posted your post and had it fact checked by ChatGPT. Then I put in my reply to you and had it fact checked by ChatGPT.
I can't edit this transcript. It is the conversation as it occurred with ChatGPT:
https://chat.openai.com/share/11208189-3977-4f30-b6f1-124b3a90c37a
In addition to my other point, for the subsequent approvals for other cancers and other applications and maybe also for the PIP program, I expect that ILAP would be a perfect fit for them to get involved with from the very start.
I know, you say you can't trust well respected news organizations...but...
https://www.cnn.com/2021/08/23/health/fda-approval-pfizer-covid-vaccine/index.html
FDA grants full approval to Pfizer/BioNTech Covid-19 vaccine, opening door to more vaccine mandates
Jacqueline Howard
By Jacqueline Howard, CNN
7 minute read
Updated 12:25 PM EDT, Mon August 23, 2021
CNN
—
The US Food and Drug Administration on Monday granted full approval to the Pfizer/BioNTech Covid-19 vaccine for people age 16 and older. This is the first coronavirus vaccine approved by the FDA, and is expected to open the door to more vaccine mandates.
The vaccine will be marketed as Comirnaty, the FDA said in its announcement on Monday. The Pfizer/BioNTech vaccine has been authorized for emergency use in the United States since mid-December for people age 16 and older, and in May, the authorization was extended to those 12 and older.
“The vaccine also continues to be available under emergency use authorization (EUA), including for individuals 12 through 15 years of age and for the administration of a third dose in certain immunocompromised individuals,” according to the FDA.
Out of more than 170 million people in the United States fully vaccinated against Covid-19, more than 92 million have received the Pfizer/BioNTech vaccine.
“While this and other vaccines have met the FDA’s rigorous scientific standards for emergency use authorization, as the first FDA approved Covid-19 vaccine, the public can be confident that this vaccine meets the FDA’s gold standard for safety, effectiveness and manufacturing quality that we require for an approved product,” FDA Acting Commissioner Dr. Janet Woodcock said during a briefing on Monday, calling the approval “a pivotal moment” for the United States’ fight against the coronavirus pandemic.
“Health care providers can continue to use the vaccine on their shelves,” Woodcock added. “The FDA-approved vaccine and the EUA-authorized vaccine have the same formulation and can be used interchangeably to provide the Covid-19 vaccine series.”
Agency official said Monday they hope approval will push unvaccinated people to get vaccinated. US Surgeon General Dr. Vivek Murthy said on CNN’s State of the Union on Sunday that approval could encourage individuals to act, and more mandates.
“For businesses and universities that have been thinking about putting vaccine requirements in place in order to create safer spaces for people to work and learn, I think that this move from the FDA, when it comes, will actually help them to move forward with those kinds of plans,” Murthy told CNN’s Brianna Keilar.
Murthy also noted “a small number of people” have been waiting for full approval before getting their shot and believes “this may tip them over toward getting vaccinated.”
Why emergency use authorization came first
Due to the seriousness of the pandemic, vaccine makers originally applied for emergency use authorizations because the authorization process takes less time than what’s required for full approval.
In July, drugmaker Pfizer announced that the FDA granted its vaccine a priority review, and the FDA had been pulling in extra help from across the agency to speed final approval of the vaccine.
The FDA worked around the clock and conducted its own analyses of the vaccine in addition to the companies’ analyses, Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said during Monday’s briefing.
“We also did benefit-risk assessments based on real-world data that has emerged since the vaccine has now been used in hundreds of millions of people globally. And so that actually takes a lot of work,” Marks said, adding that the agency also inspected facilities that make the product.
There is no 150 day expedited approval program in the UK other than ILAP. I don't think it has any other meaning. But I don't know that they are seeking any other assistance at this time, so I doubt they will promote anything but whether they were approved for expedited review and the application was accepted. ILAP can be applied for early on in a trial, but the program was only announced in recent years, after NWBO had already finished the Phase 3. They seem not to be talking about special programs and that may simply be caution. Any such chatter in the past has been used to suggest negativity. But they clearly fit within the expectations of the program. The program was introduced to expedite drugs exactly like and in the position of DCVax-L to patients in the UK. That the drug was far along and had already completed its trials should not prevent them from applying to be considered for expedited approval. They seem reticent to talk about such programs after their past experiences.
I'm not saying that.
This is not new information. They can't market it, but they can make it, provide it and charge for it. Compassionate use. Why are you acting like this is some new revelation? They do not have to give it away for free or below their cost while maintaining a proper factory, which the older compassionate use programs required, and which made them impractical generally.
But the Specials program is not ILAP. It is merely a hint of favorable regulatory disposition toward the company and product. Do you or any person honestly believe that they would allow the licensed commercial manufacturing of and sale of DCVax-L to deathly ill citizens if the regulator believed that the trial was a failure, and the treatment has no potential benefit to citizens at all and any claims to suggest that are fraudulent? I don't think so. I think they protect their citizens quite carefully. A few years back, Apple made some claims that others questioned about their computers and the UK prosecuted them for it. Of course NWBO can't make any claims or do any marketing. The prescriptions come directly from doctors. It's not the same as already being approved, regardless of what others say. They still need to go through the full process of review and approval. I do not anticipate that the would fail, given what we know generally, but that's JUST my personal opinion and everyone should make their own conclusions. Given reality, of course, anything is a possibility.
As for ILAP, I've followed that program for a long time. There is no other accelerated program of which I am aware that has that kind of timeline. DCVax-L clearly fits within the qualifications to be considered for ILAP. There is no specific time that you can or can't apply. Applying earlier is better, but these guys were already done with their trial when ILAP started as a program. I think they might be entering later in the program and these programs are intended to assist companies all the way along. But the accelerated 150 day approval process was proposed as part of the ILAP program, which was created to replicate what they viewed as the efficient approval process they went through in recent emergencies.
Agreed. I think we should look to them to follow their own rules certainly. And of course they can always ask questions, but I think the company has likely worked very hard with the regulators and advisors to create a very thorough application. In theory it could come earlier. We would all love that, but the company was wise to put the regulatory guideline into their PR.
The accelerated program is ILAP. 150 Days is the regulated timeline. I have been quite sure this fits that programs parameters for some time, the company is giving that timeline because they have been in consultation with the regulator. The regulator has gone so far as to allow them to sell, pre-approval, at full cost, to U.K. citizens, under the Specials Program, and to license their factory knowingly for such purposes, given open PR’s and discussions, again likely under ILAP, which is a program that starts long before an application is submitted and provides guidance and assistance planning their regulatory approach.
The regulators have strict requirements and follow their requirements. I won’t ever claim to know the future and all future statements are protected by the safe harbor, but regulators do not claim such protections. If it says 150 days, then that is the intention of the law, which is different than future statements for a regulator, not for NWBO. I would expect the MHRA to work hard to keep that deadline.
They did not apply for EAMs because it was a crap program just like the U.S. current early access program. It put the burden on the companies to supply the drug at their actual minimal cost, which would not recoup scaling up a factory, hiring people, getting a commercial license and basically operating as if they were a commercial entity. That was a non-starter not just for NWBO, but if you peruse the companies that went through the hurdle of the initial designations, you’ll see that it required regular renewal and most did not bother. The EAMS program basically was a failure, hence the U.K. Specials program as a regulator driven work around basically.
Understood. I know exactly what it is and was. However it was an early access designation as was the HE, which you conspicuously failed to mention, and both, after review by the regulator and in the context of the HE included substantial due diligence, decided to include a BROAD designation when it wad not even applied for…
https://nwbio.com/nw-bio-announces-two-german-approvals-hospital-exemption-for-early-access-program-with-dcvax-l-and-eligibility-of-dcvax-l-for-reimbursement/#:~:text=Under%20this%20Hospital%20Exemption%2C%20NW,be%20from%20Germany%20or%20elsewhere.
The approval of the Hospital Exemption for DCVax-L is the culmination of nearly two years of regulatory processes and scrutiny, starting with a Scientific Advice process during 2012, and followed by an application for Hospital Exemption in December, 2012. The evaluation of NW Bio’s application by the German regulatory authorities included comprehensive and detailed scrutiny of all aspects of the DCVax-L technology, all DCVax-L clinical data to date, all manufacturing processes, all product characteristics (including potency, composition, sterility and other aspects), all frozen storage of DCVax-L and frozen shelf life, and all distribution and handling of the DCVax-L products.
Although Section 4b of the German Drug law for Hospital Exemptions was implemented in July 2011, the approval for DCVax-L is the first such approval granted by the German regulatory authorities in multiple key ways. Only two prior approvals have been given in the more than 2-1/2 years since the law was put in place, and those were for two German companies with tissue engineered products which had already been on the market commercially under prior laws and were grandfathered for regulatory purposes, and which did not have pharmacological (i.e., drug-like) effects in the patient’s body.
In contrast, DCVax-L is the first product of its kind to receive Hospital Exemption approval from the German regulators, in the following key ways:
the first immunotherapy;
the first product which exerts pharmacological (i.e., drug-like) effects in the patient’s body;
the first product that has never previously been on the market commercially;
the first product developed by a non-German company, not previously under the German regulators’ oversight; and
the first “somatic” cell therapy product (a somatic cell is any cell of the body other than a reproductive or embryonic cell).
Furthermore, the scope of the Hospital Exemption granted for DCVax-L is broader than the scope of NW Bio’s ongoing Phase III clinical trial (which must focus on a homogeneous set of patients in order to produce data that can be compared between treated and control patients). The Hospital Exemption for DCVax-L applies to all glioma brain cancers, including both the most severe grade (Grade IV, Glioblastoma multiforme or GBM) and lower grade gliomas, while the clinical trial includes only GBM. The Hospital Exemption also includes both newly diagnosed and recurrent gliomas, while the clinical trial includes only newly diagnosed.
Based upon data from the German Brain Tumor Association, there are approximately 7,000 new cases of gliomas (primary brain cancers) per year in Germany. These would include approximately 3,000 cases of Glioblastoma multiforme (GBM), the most severe grade of glioma (Grade IV).
DCVax-L products that are to be covered by the Hospital Exemption in Germany must be manufactured in Germany, but can be administered to patients from anywhere. …
Whether the PIM or the HE, both were very broad, so i think it is likely they get a broad designation for relevant brain tumor indications. It also helps them if more patients are eligible in a number of ways and likely increases scale and therefore economic viability for a company providing the services/product, which in the long-run improves cost competitiveness of NWBO with anything else that might arrive.
It’s not actually a pricey drug. The cost of treatment looks like it will be quite a lot less if you measure it by month and also the fact that it has virtually no side-effects, can be given in a community setting and extends life. In fact, it probably could justify premium pricing more than what is anticipated, if they asked for it, based on the survival results and based on the poly-iclc results especially.
And if they give them a broad brain cancer label, it’s actually a pretty decent size but they can still get a substantial revenue upon which to base a substantial increase in value even on the UK alone.
But more importantly, the U.K.’s decision will likely provide approval in their treaty and commonwealth countries, including Canada, but a variety of other nations and as well would likely be a good predictor of approvals in the US and EU.
You’ve got drugs that cost almost a million in treatment costs with deaths and serious side-effects that are already approved for a variety of cancers, and yes, those post problems, including CAR-T and Keytruda, with it’s side-effects and relatively high cost over time. You have Optune which is many times more expensive.
So in comparison, the cost of DCVax-L, plus it’s actual increase in mOS and long-tail survivors as well as for subgroups of patients and recurrent patients is a game changer not just in results but in terms of REDUCING costs compared to other “cutting edge” options already approved for other and cancers and for GBM, but also in terms of life extension and allowing a good number of patients to resume their regular lives, some for an extended time, others indefinitely.
Shorts “invest”, they’re “shareholder advocates”, were you not told? That’s their legal defense for manipulation. Plus they swing trade.
You always say things like that because you have claimed this entire endeavor is a fraud, which is so obviously wrong. So the notion that you’re “right”… well a broken clock is correct 2 times every day. Your record is far less successful than that. Predicting they would not file last year and again this year when you say it is a fraud is pretty easy, with your presumption. But it should not be used to suggest you somehow have an accurate record of prediction.
Agreed. It will be brain tumors first, starting at least with GBM, but there have been good indicators for other brain tumors also, with the HE in Germany previously giving them very broad coverage, so they have a very good shot at all brain tumors or most potentially, beyond GBM.
Then under that 21st Century Cures Act getting off-label insurance coverage and Medicare coverage now should be very easy. Just a little RWE justifying, small studies.
Expansion of the label formally can also be justified with RWE now, though you’d probably do more formalized trials also, to provide practitioners with compelling evidence to make your treatment a new SOC for those other label expanded uses. You’d probably do both, get approval for patients to get it, but also have a trial for the importance of establishing a strong benefit and publishing.
There are many more ways to make a drug available broadly to more patients than there was in the past and that includes with proper allowance and justification for medical coverage so that patients can afford such treatments.
And why do you waste your time pretending this and that when what you do and say is so obvious? Infiltration is a way of faking sincerity and falsely making oneself “believable” and trustworthy. Why would anyone have to make such efforts if what they said was true and factual. They wouldn’t.
You’re on repeat and repeat for you has been 100% wrong, over and over and over again, along with the false facts and spin that you spew.
Soon you’ll have to find something else to do.
Thank you Senti! Merry Christmas, Happy Hanukkah, Joyous Kwanza and a wonderful New Year ahead to you, your family annd loved ones and to all!!!
Though it could just be because things are late, the total delay of scheduling an annual meeting could very well be because some larger development is in the works for which a shareholder vote will be a necessary part. So I would as much as possible buckle my seat belt if that is the case.
That is irrelevant, the initial introduction footnotes to Dr. Liau’s work on DCVax-L, including the interim results publication and the publication of the final Phase 3 results in JAMA Onc. NWBO is not a sponsor but her work on the vaccine is cumulative, and over time. The notion that she starts every test effort and variation with an entirely new vaccine despite getting great and intended results with the vaccine they started with is a bizarre notion that only shorts would suggest as if it were a serious discussion point.
The UCLA work stream is determined, focused and scientifically rational, not fickle and nonsensical, as shorts would constantly suggest.
Thank you. Merry Christmas and Happy Holidays to all!!
Hi Gary. Marry Christmas and love you man, but you can really misread things.
I did not really mean "give" it away, I mean allowing anyone else to have it and characterized it as giving away because beyond having their own factories, that would be what it would be. Doesn't matter if it's leased or sold or licensed. Once out of the bag, it's out of the bag.
Patents on machinery like that are useless in this day and age, in terms of stopping competition. I have given you examples but they seem not to be registering. Whether someone patents a computer, or a Xerox machine, someone will always find an open source, simple way to backwards engineer it once they have a copy of it. Never fails. Patents do not stop that. You want to license to a Chinese company no less, and that is the fastest way to losing your IP known in the modern world. Stealing IP is how much of Chinese industry was created. Unfortunate, but well known to be true.
The patent is on making the drug. If you believe that City of Hope has created DCVax-L, in their clean room, you've just provided an argument against your argument that patents protect anything. However, I seriously doubt they have, and when you give away a recipe, you're no longer a drug company. A lot of what you say on this topic indicates a naive understanding of the purpose of drug regulation, how it works or why it is what it is or how drug companies make their money. I know that you do know but your points often contradict that knowledge or other points so I think some core idea or concept is being lost here in the conversation. As for doctors who think they've done things they almost certainly haven't, or brag that they have, they probably haven't done it. I'd take fish tales with a grain of salt. That is not to dismiss that good doctors give great care or that patients have not benefitted from great science over the years. But if a doctor is telling you he invented DCVax-L before Dr. Liau, but just never got around to doing a trial and patenting it, that's a fish tale.
I did not suggest they sell Flaskworks. I may have pretended to follow the logic of becoming an equipment manufacturer, but that is definitely not something I'd suggest they do. I doubt they would get any more for it than they paid, probably much less at this stage, once stripped of its founder and the core value has been taken out by NWBO and patented for themselves. I really can't see any value at this stage in doing any of that. The could buy Advent, fold it into Advent, spin it out keeping some equity, but again, any equity diverted to a low margin, competitive business like machinery manufacturing and sale as opposed to putting it into a cancer cure platform that works, that would be wasting money. Selling it would have little value. Buying Advent is likewise not a good use of capital if they don't have to do it basically just for the personnel but keeping a CDMO running generally, internally, like I said, is a diversion of good capital into a marginal business compared to investing those dollars into developing the DCVax platform, assuming it's the amazing, agnostic solid tumor treatment we all believe it to be.
Running any business, other than the business to validate, manufacture and sell DCVax and its relevant potential combination drugs, to make a profit takes precious capital, substantial value from developing DCVax. It would be a distraction. Flaskworks was in the business you suggest, and it did not fly. But also, NWBO's patents for DCVax are process patents. Flaskworks, as it becomes a key part of manufacturing, becomes a key set of patents not just for the machinery, but for DCVax protection. Distribute it, and that s lost. People in the meantime will need to find creative ways to get around the DCVax patents, but you don't want to make it faster and easer for everyone to do it. But also again, the entire venture and notion of IP, seem like magical words in some discussions and lack context or practical meaning for some people in these contexts. It is very important for them to protect their IP. It will be core to their being an economic success, and being an economic success if they really believe in what they are doing, is the only way to ensure that the science of it continues to develop and be provided for patients. If they go out of business because they sell too cheaply, or because they have non-commercial aims, then that will in the end either ensure the end of this science experiment, or hasten competition, or a buyout that Martin Shkreli would be proud of when that buyer gets the shell of the remaining company and ends up charging a million dollars a dose for DCVax, because those behind the company wanted to run a social cause rather than a strong, commercial business. I don't think that will be the result, but I do think some think that is the aim. The aim must be to commercialize this technology and ensure that it thrives, develops and endures as a valuable new oncology treatment paradigm.
Agreed. I can’t see ExW’s suggestion as at all realistic or reasonable given the basic details at each level.
Thanks. Yes, I think sending them back for a confirmatory trial would not be practical nor would it work, given what we know. And it is not consistent with their other approvals of less promising treatments. As a rare disease as well and given all the further confirmatory data, it would make no sense. Not to say that regulators always do that which makes sense, but I think they would necessarily come to their senses when they’d see what many of us see.
I accept your refutation. But the others did not. And in fact some affirmatively accepted the bet.
I think you added the link to that last post after I had read it already.
They did not go for accelerated approval, they went ahead and extended the trial to prove OS. Another trial would do not good because the regulator wanted the crossover and adding crossover again would create the same problem and not having it at this point would be deeply unethical.
So your point makes no regulatory sense.
They have extensive evidence from a variety of trials and real world evidence indicating there is a response, there are virtually no side effects and there is an extension of survival not explained by anything else. Requiring a control and another trial for a rare disease is unlikely given that they have approved other treatments that literally failed and had serious side-effects.
It may make sense to you, but not to a broader audience, not to doctors or patients. If it were an early end based on a surrogate, then they could ask them to prove survival. But they can’t in this context ask them to do a new trial, with an internal placebo, no crossover, given what everyone knows. No one would join such an unethical trial.
I think you have ignore that basic logic because you want so badly to prove you’ve always been right.
As I said, I have not seen that refutation. You just agreed you saw that post. Confirming what is obvious. Where is that refutation to that specific post before the filing of the application? You said you posted such a refutation, all you had to do was post that specific refutation and say here I refuted it before the filing… this is the post that was in response to that bet post.
I was not a part of your bets, as I said. Was not paying attention, but those sound like past bets to me. What I saw was one large post listing names and virtually a whole day or few days of chatter of who all was betting as of now, about a week ago, that they would still get it done before the end of the year, not based on earlier in the year bets, but based on their last PR.
As I said, you are an active participant here. Virtually no posts go by about you that I have seen where you did not refute something that listed your name incorrectly. Those posts were up conspicuously, based not on the entire year, based on this last few weeks, listing various shorts and I saw none refute until they lost. They were based on the last PR and discussion of whether the application would even ever go in and if so, this year or next. Dow of you shorts were saying never, not just that it would not happen next year.
That’s a kind of taking advantage of circumstance to see if it goes their way. Posting past bets, claiming one thing when you were listed for another and did not oppose that you had agreed. And like I said, I never believed it anyway. But I think shorts allowed their names to be listed in that bet so that more longs would list their ID’s in the other side of the bet and had the year ended without application, not approval, different bet, then those same shorts would have held those bets over those longs. And the bet got juicy, you had longs like Flipper and Hoffmann and Danish….
It’s not selective memory. It’s a different bet entirely. Shorts lost so of course they “never agreed”, etc.
She funded Cognate that was bought by CRL when shorts blew up that symbiotic relationship, and yes, she was able to preserve access to that know how that they had developed through that relationship by taking a part of her payment with this subsidiary of Cognate, Advent. Advent continued to provide the same services to NWBO under the same contract with Cognate, which because of shorts was investigated and apparently was fine as to charges and costs certainly at that point and in fact Cognate had partially funded NWBO with very favorable funding that shorts targeted and blew up as a part of their short strategy.
So the fact that you target this relationship too, is no mystery. It worked for you previously. However, advent is not providing easy funding for NWBO in the same way, so you can’t derive the same shorting benefit by blowing that relationship up.
MOMA is fantastic. One of my museum memberships. Fantastic collection. Just love it. You really should go next time you come to the city.
That’s you. Project much?
Advent is a contract provider of services. They manage the operation for manufacturing but they do it in the clients location. Why is this so fricking hard for you business neophytes? You keep saying the most stupid things as if you don’t get this contractor notion, as if it is an invention wholly new in the universe to NWBO.
It’s not. Yes, they have employees, whose labor and pensions and benefits are on their spreadsheet and they bill out for it. Such employees on a decision by the contracting firm can move with Advent, their contracts can be bought out and they can remain with the contracting firm. These kinds of arrangements offer maximum flexibility to the end customer and that is NWBO, not the patients, NWBO.
Get it through your thick skull. Advent is not the main deal in this relationship. Advent provides a service that can be transferred back to NWBO, and there is a provision in these contracts to ensure that Advent makes sure that is done in an orderly fashion. NWBO can also transfer it to another firm. I don’t anticipate NWBO will do either thing because the relationship is a positive one and symbiotic. But the value is NOT with the CDMO, not with Advent, and Sawston is not a separate company, it is an asset on NWBO’s spreadsheet. Advent has a license to manage it based on the IP and processes owned by NWBO, and all of that can be orderly transferred to NWBO or whomever NWBO decides to transfer it to, obviously in coordination with a regulator, but the processes and personnel that get slotted in, that is already part of a process and licensing structure set in place, no huge mystery, nothing special that Advent has that can’t be set in place should the contracting firm, NWBO, decide they want to now hold that responsibility. When NWBo pays them, that pays for staff. They have a small initial space to fulfill NWBO’s obligations for regional financing, to contract for services to local small firms too, but that obligation could be handled by anyone designated by NWBO. Advent contracts to provide services for payment only. The IP, all of it, belongs to NWBO.