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Name calling is for the people who actually have nothing to say. You pervert the truth in some instances. But generally speaking, you tell lies daily.
Of course this is a false description, but that never stops you. PFS is only for early approval. It is a surrogate measure for survival. But with immunotherapies, especially brain tumors, early on the methods for determining recurrence did not take into account the actual response to an immunotherapy, which, duh, causes inflammation, which looks like a flair on a scan, but is actually the drug working. They can’t take back those designations, but when everyone is living longer, a lot longer in certain instances, that is a survival benefit and that would make PFS in this instance, the old way of measuring it, not a valid surrogate for survival and therefore not a valid measure of failure or success in any way.
Subsequently, PFS has been adjusted, PFS+6, for instance, but this trial was already started and far along.You can’t adopt a newer PFS plus that may be flawed as well. Hence, better measures have evolved and NO, they couldn’t just throw in some ORR, at that point. That’s ridiculous and stupid and shows you have no idea of what you post.
They got permission to make OS primary, and to use a very thoroughly vetted, externally proposed, expertized, blinded placebo based on concurrent trials that has the same placebo standard of care.
You can invent all you want. You can look to doctors with competitive treatments to make the argument based often on ignoring key parts of the trial, and details.
But the reality is, virtually all the other drugs that have been approved have in fact actually failed, at one point or another and still been approved based on other data. This trial does not have those problems.
People post those screen shots regularly. Yours doesn’t show your ID. No way to know if that is true. And we know the rest of what you wrote is flatly false.
I don’t believe they have it in that form, that it is available to personnel who would be doing such work or that it is available generally in the way the suit suggests. For their broad claims, depending on the judge, and they likely brought it somewhere in a favorable forum, they might even be successful in undermining regulation, and market surveillance. But the unfortunate likelihood is that they are just making the SEC more blind, and that is the purpose of the suit. And the SEC is definitely not going to suddenly start doing anything remotely as you suggest particularly but not likely because of the suit you point to…
I think your description of the game is a far more accurate one Beartrap, and a more likely unfortunate outcome. I agree that it is in the day-to-day manufacturing of a market and settlement back and forth, that that “naked short” market exists. They fill orders without the shares, back and forth to each other, they roll the FTD’s forward filling the ones at the end or later in the process first, and they ultimately settle up, likely regularly, for unaccounted shares that were not going to any real retail accounts in the end anyway. In the overall process, their big clients get “favorable pricing”…
It’s a BS suit and surveillance data like that is not used for prosecution. It’s used for broad market surveillance. Assuming that what is in one category can be used to other categories when likely the law is written very distinctly, to ensure compliance with the Cinstitution just because some anti-regulation, not pro-regulation toady fake third-party says so, is not the way to get real information or understand what is really likely going on.
Further it is doubtful not just that it cannot legally be used, but also that it is actually detailed enough to be useful for the purpose you speculate it is useful for. Extremely unlikely.
It is doubtful that anyone who has shares and has held them for any amount of time, does not have shares or won’t have shares. It doesn’t really work as simply some who speculate on this topic believe. At the end of the day, if literally they were short shares, there would be an increase in volume and price until the relevant accounts are covered and anything else is covered by normal market processes, at their brokerage.
No retail shareholder will be left holding the bag and it is doubtful there are enough such shareholders that that would be the case, which is why they can manipulate the market so completely.
Most likely it’s just general market data and is not intended to be used as alleged, and the lawsuit itself, the group behind it is likely funded by hedge fund founders and similar people who do not like any possibility of prosecution for market distortion.
But I doubt that is what this data was being used for. I doubt anyone’s personal data, wrong doers or ordinary citizens, is available through this surveillance for individual prosecution. The lawsuit will likely make any use of it, even if they had the relevant data and could use it, impossible until and unless it is dismissed completely.
It’s doubtful the data is for surveilling individual trades, likely hasn’t the right detail for this kind of case either. As I said, probably more for observing the market broadly. The’ve never heard of anyone being charged with such data not directly from their financial institution, and I doubt we would ever hear of such a thing. Though banks/broker-dealers and hedge funds likely do not want any kind of market surveillance if they can stop it in any way. Fox is reporting such suits as if they are protecting ordinary investors investors, but that is definitely not the intention. It is to reduce regulatory compliance burdens for larger intermediary players and reduce the risks that data will show they maybe manipulate markets in unfair ways, though doubtful that would easily be shown for any individual company or shares.
Shorts love to squeeze these stocks before news hard to squeeze out the longs and manufacture panic.
No, I do not say that, I appreciate anyone as they actually are, but I am amused by the effort to hide by inquirig so vociferously being upset at me early on because I did not realize the Inquirig ID was a lady… making a clear effort to make people take note that a lady had joined the bashers… must be someone “new”…not.
In this case someone attempted 2 identities by saying they were two completely different people not just by ID name, but also gender. That was purely for the purpose of hiding their sock puppetry.
Ahh, but Nemesis is a man boy and Inquirig insists to be a lady. Yet the same person, same mean tone? This site never ceases to amaze me. Who needs to travel to see the wonders of the world? Two ID’s, one person… Incredible.
If the issue is naked shorts, the problem would be that the trades are not properly documented by definition. Access to falsified records from brokerages at the DTCC would not reveal anything.
Which literally has absolutely NOTHING to do with this company or DCVax-L. You’re just here because we are a captive audience.
If you can read like everyone else, why exactly are you presenting patently false information? You can’t read apparently or you lied.
The company clearly reported their result and the difference and the fact that it is a significant benefit for virtually all patients generally and there are specific groups of patients who did incredibly better than the median. By a lot. And subsequent studies are showing that with combinations to address secondary immune responses that typically happen because the body misidentifies an immune response as an autoimmune response, or because the immune response is not as vigorous though the right targets are identified. These methods of action are cumulative and are being addressed with the relevant drugs that are already approved that will enable what looks like it could be an incredibly strong and broad immune response from the pending paper with possibly Nature.
In fact, in a key arm, as you know. 100% of the patients are still living, all over 9 years of 4, and 3 of those over 10 years, all still alive, last we heard. Not GBM, but serious brain tumors for which shorter terms of survival are typical.
As multiple survey papers have suggested as well as the JAMA paper, there is no reasonable alternative suggestion for the increased survival though our resident shorts like to argue that larger tumors that can require surgery are “better”…
No, the 3.1 months was subtracted. Is says so clearly in the JAMA article explaining the results. If you include that time, patients had an additional 3.1 months behind the current survival benefit.
It discusses the 3.1 gap multiple places including in the visual you linked to, and in the results multiple times it explains the gap.
A long time ago I dug deep into pre-approval manufacturing gearing up to commercialization. It was my conclusion back then that regulators make a special effort before approval to make the new technologies companies understandably implement prior to approval, gearing up for approval, easier to get approved. Further, having the ability to potentially meet demand and create a treatment that is validly not just efficacious but deliverable, is a consideration for the regulators.
So at that time it was my conclusion that they would likely delay until they had gotten their commercialization and specifically their manufacturing technologies to a certain point in the regulatory process before applying to any regulator.
I am sure they would have loved to have had more availability for patients sooner. But there is only so much that can be done at any given time. The obvious solution has always been to have many more resources but the objective of all of the shorting has always been to keep them short on resources and maximize dilution. In that context, the shorts have been successful. But shorts cannot change the technology.
At this stage, it’s moot and regardless of bulletin board chatter about old ideas, all the facts literally are out and it’s quite obvious in my view. There would be no point in putting out such a PR or further details about that. It is not currently material nor has it really ever been likely to be material for approval beyond the details we already know and those are: 1) the placebo arm was not fit for purpose; 2) but they did ultimately repurpose those patients for recurrent GBM; 3) they extended the length of the trial to get OS data because PFS data was also not fit for purpose in that it was not correlating, clearly, with survival data, and that is the entire purpose of PFS data; 4) they were given permission to and hired an outside firm to create a blindly created, external placebo arm, for comparison of OS date; 5) all kinds of additional statistical work was done to ensure that that arm was very accurate and likely to be true and fit for purpose; and 5) end results were published and validated DCVax-L as statistically efficacious and valuable as a new potential treatment for GBM and possibly other cancers given it’s mode of action.
I do not think there is any other reason to say more except to feed trolls and people affected by trolls. It definitely would not help either the regulatory processes of approvals, nor likely really lead to investors being “more informed”, given what we know shorts do with such information and even undeniably positive information.
It would serve no one’s interest but the shorts.
We will likely hear the full story once this is fully approved and in hospitals giving encouraging or even miraculous results. Then it won’t matter what shorts say. And they will likely be on to new companies and new skulduggery.
I believe it’s quite obvious. The placebo arm had too many crossovers. It was not fit for purpose. At that moment the FDA had not formulated a strategy to address an ethical problem that they created. Also, telling the company “why” or that the regulator had stopped randomizing, which appears to be what happened, would technically spoil the trial by effectively “unblinding” them, even if it wasn’t a true “unblinding” once you have an external placebo arm.
But technically, I believe the regulator made a lot of calculations to avoid spoiling the trial for a large number of ethical and other reasons as well. So transparency was really up to the regulator. But the regulator couldn’t be transparent for a slew of reasons including potential liability and spoiling scientific research that literally could lead to a cure for this disease. There was more to lose than to gain.
Except that is the mean. We know for some patients, they appear to be virtually cured. There is no sign of recurrence or disease after 5, 10, and even over 20 years now. The object will be to find the lock and add the additional keys to make that a more common or most common result.
Both false. It was a partial halt, not for safety, and apparently it was the placebo arm that was halted because too many patients had crossed over and randomizing patients to a placebo arm that was no longer valid, would be unethical. You can’t tell the company or the patients to avoid spoiling the results.
And the fact is no, the placebo arm MOSTLY crossed over as recurrent patients and we know recurrent patients had an incredibly great survival response as well as newly diagnosed patients.
The measure you claim it failed on is invalid. It is not a valid measure correlated to the survival of patients. PFS is ONLY valid as an early predictor for survival, and then you have a Phase 4 to confirm it. Most of the other, already approved, early, based on PFS alone, immunotherapies actually failed to prove survival in many cases. Yet the FDA allowed most to stay approved for other benefits.
In this case you have even more quality of life benefits, you have a clearly applicable idea of how this will likely work, method of action, with other immunotherapy drugs and not least of which, you actually have the first substantial improvement in OS for many patients, some seemingly cured, for a systemic treatment in many, years, probably actually ever.
Your claims are part of the formalist rejection of progress because it will endanger their profits in treating very ill people. There are no doubt massive profits that will be lost for the ameliorative products if drugs like DCVax-L come to market and in combination do prove to ultimately cure a substantial number of patients without the horrors of treatment that cost so much and bankrupt families.
We see these same posts on this obscure board non-stop, different ID’s, same attempts to sow fud.
Reasonable question. No one is asking you to invest. Yet you approach as if they are and you must tell us why you won’t. Strange to come here to tell us such a story…. This is not Twitter. You are looking for a specific audience, not a general audience that won’t be interested, to tell that story and the reason is OBVIOUS.
I don’t think that is “the argument”. That is a gross oversimplified notion of value.
That’s true, but also many tiny bios also don’t pop early, and even get a product approved that is way better than other products on the market and still don’t pop. Markets and competition in these markets are not completely obvious from a market cap perspective. The markets are driven often by people waiting for other people or forces to give them “the sign”, and that “sign” can often be delayed. There can be other dynamics at work. You still have to use your common sense. But if timing is wrong for you, or your skeptical, why waste time here with us? The markets are large, go chase your dream company. No need to hash it out here with people who are invested and do think otherwise than you do.
These two things have nothing to do with one another except for the fact that this is a single product company, shorts spent their time spreading fud and the fact that they had to run the trial, under ambiguous circumstances, for a long time, meant uncertainty, which of course shorts exploited by shoveling crap into the understanding of what was going on. No one knew for sure, and shorts make their living by accelerating dilution by massively increasing anxiety, fear and misunderstanding. That’s just what they do. It’s easy money, you scare the retail investors and take their money… like stealing candy from babies…
It’s not relevant at this stage. It’s just them crying because the trial still proved a survival benefit after extension for a number of years, instead of an early approval with a phase 4 to prove benefit, which is how that works. We saw numerous immunotherapies that had been approved on PFS grounds that ended up NOT having the survival benefit that was assumed for their approval. Some approvals were then undone, and many continued anyway, for other reasons including quality of life. Almost all of the big drugs have those issues in trials.
So NWBO let it run, not because it failed but because the secondary could be primary, but they still needed a control arm, and the regulator allowed them to seek a blinded, expert, outside epidemiological and statistical firm to create that arm with a very large number of concurrent and similar trials. There are still jealous competitors wandering about because of it. And we see them every day.
Their anger has nothing to do with the validity or the statistics or the proof. It’s pure jealousy.
PFS is a surrogate endpoint for OS. It was not a real endpoint. It was for getting an early decision.
https://www.onclive.com/view/fda-will-reassess-6-immunotherapy-accelerated-approvals#
https://www.ajmc.com/view/fda-panel-votes-to-keep-4-of-6-dangling-approvals-in-a-sign-of-things-to-come
In the case of DCVax-L, they still had to do the statistical study, and in a way to eliminate “bias”, which they clearly took pains to do, with the blinded, outside, expertized statistical and epidemiological firm. And they needed to let the data run to get 5 year survival data. I don’t think the 5 years was set in stone but clearly seemed prudent to those advising. The end result, was, as we saw, excellent survival data that rivals will of course attack, because that is what “rivals” do. But they know that regulators cannot and should not reject based on their bad faith critiques. Of course, my opinion only.
I have very little doubt on what I said, and I definitely do not think there was a conspiracy. The conspiracy were the people making investors paranoid on bulletin boards that led to all of these theories. It’s quite obvious that the placebo arm was not fit for purpose and that is why it was a partial halt to me.
And let me just clarify why the placebo arm would not be fit for purpose… because the patients perceived that patients who got DCVax-L, at least outside of the phase 3 trial, had had amazing results. Obviously, the Phase 3 was blind, but there were many compassionate use, side arm and earlier trial patients still walking around in apparent good health.
So when you’re a patient and enrolled in such a trial, you’re likely going to want to “cross-over” to receiving the drug if you might have been the placebo arm patient.
So many patients crossed over that there was literally no longer a viable placebo arm. THAT is not the hallmark of a “failed trial”… it would be pure idiocy to claim it, but shorts and hedge fund types enjoy assuming retail is not intelligent, throwing up lots of smoke and false information to always move the shares where they need them to enable their own profit, at the expense of the companies, researchers, research institutions, long investors, company employees and especially their patients and future potential patients and the field of medicine.
This is false. They did not adjust the trial did four years after it “ended” or “failed” or whatever false claim you want to make, it was allowed to run. Patients already enrolling were allowed to enroll, but placebo patients appeared to be short at the end of the trial, likely because of the partial halt. That to me is significant. This suggests that because of the crossover and lack of a remaining placebo arm, the placebo arm was not fit for purpose, but the regulator cannot tell a company anything during that time to avoid spoiling the trial. So that likely was the reason for what you falsely suggest was a full halt, but was not, and was not for safety or any other reason you’re likely to suggest.
The lengthening, was allowed because OS was always a secondary and in fact, as I said earlier, PFS is just a surrogate for OS and not typically a real measure of success. Where there is an indication that PFS does not predict OS, which is apparent across various immunotherapy trials, where pseudoregression is also apparent, but patients are living longer nonetheless, the regulator is not going to declare that trial a “failure”. That would be idiotic form over substance, would be contrary to the scientific method and generally a sign of immense denseness.
Further, the adjustments to the trial were all done before unblinding, not after, while your post wrongly and deceptively suggests otherwise.
In fact it wasn’t and PFS is not a direct measure, it is a surrogate measure of Survival (OS) for expediting trials and is ONLY truly valid when it predicts actual survival.
In this case, they extended the trial so that all participants had been in for 5 years and more, to validate long-term survival statistics. It was then measured against concurrent similar trials with the same placebo/standard of care to show the OS here against literally hundreds and also thousands of patients for newly diagnosed and recurrent patients from the intended placebo arm that was lost due to overwhelming crossover, which was ethically mandated by the regulators.
This has been discussed and put to bed. Simply because you keep refusing to accept reality and keep trying to make a confused, technical argument to confuse newbies, it doesn’t make anything you say remotely accurate or truthful.
Awesome. Thanks for tracking!
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It was green. It will likely go back and forth since it is a non-news day. These stocks go for long periods with no news, and the movements are unpredictable and usually not super dramatic without news though a stock can drift far and all over the place until there is news.
It’s a single product penny stock. That’s how and that is not unusual. Even large companies with incredibly promising drugs, often the drug and the doctors get coverage and you’d be lucky if you find what company is behind the drug in the articles. So no, it’s not exceptional given the circumstances or even the industry.
Except I just told the truth and details and you just expressed your annoyance at the truth. Isn’t that special…
Only a portion of the facility, the old technology part, and that will be used most likely to fulfill the company’s obligation to the regional funding authority that bankrolled creating Sawston. The development comes in phases and Sawston does not own it, they lease and provide services in a minor footprint and for now, they are the contract manufacturer in that footprint. The arrangement is totally rational, minimizes risk and is flexible for the company, something a predecessor firm did not do, and it got that company into trouble that this company has completely avoided.
Assuming it is so, I agree, totally nuts. But fund managers often put particular demands on people and they may have pressure more to maximize returns in the short run rather than to think long-term and some young trader may think he stumbled on an opportunity to short. It’s unfortunate. You’d think they would have policies against, but the CPP does operate with more risk. Years ago I used to see them doing very risky international investments that were way riskier than similar “funds”. So anything is possible.
You try too hard.
Agreed.