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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!
..
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.
Thanks. Fascinating. I would not think they would do that kind of trading. Especially not if it affects Canadian Citizens since they are the national pension plan, like our social security.
Seems like someone could be in trouble.
Hope owns shares and is chatting with fellow investors on a very narrow focus investment board created for people interested in investing in this very tiny company. You’re not an investor. Yet you spend all your days here, in this obscure place that is definitely not Twitter, or YouTube or Instagram or TikTok, where I understand you could make a lot of money if you just focused better on more constructive activities.
H George. I would not be surprised, but I don’t recall ever seeing this discussed here or elsewhere. If it were the case, then it seems like good news for patients, though it would be better if it were approved and covered by NICE and likewise approved in the U.S. and other countries.
Shorts who claim no interest, diligently posting 24-7-365, quite a strong interest in this obscure bulletin board and stock.
I agree. They seem terrified. Inquiries again to borrow more shares continue to suggest so as well.
And here you are, replying to the same poster.
They still show up on ignore, and they post and talk to each other. When I came last night they were all over the board and longs were quiet. That’s what happened to the yahoo board. Leaving them to dominate the board doesn’t make them go away. This is not Twitter, so they don’t get more followers because you reply to them. It doesn’t work that way on bulletin boards. Instead, the bulletin board dies and becomes the property of people who make up false narratives.
There is no one named BioHarm here. And the shame is upon people who make their money as flat-earthers preventing new advances from reaching patients and the markets.
Well, it has impact across the entirety of patients and it’s mechanism of action is complicated because the human immune system has layers of complex defenses against autoimmune reactions, which is why they consider the method of action and recognize that drugs like this work with other immunotherapies when properly understood. So your simpleton’s approach to drug approval is not where things are nor where they are going.
And quit it with the “vaccine” in quotes. One minute you’re belittling that it is a vaccine, the next you’re pretending to be an anti-vaxxer complaining about this being approved like the COVID vaccine. You’re all over the place to just cause problems. Like I said, an arsonist.
Quit coming here and belittling investors. You have no place here if your only job is to harass.
The application has been made. I belong here, and I don’t know what you think your role is, but it makes little sense that you post non-stop on this investor’s forum that is obscure and addresses shareholders and all you do is belittle and offend them.
Because you spend your time harassing people here. This is not a place for you. You might try your local park Karen. You apparently wanted to harass King’s College by posting here. This is not King’s College. You harassed regulators about this drug because King’s College was involved, Karen.
Quit it with the nonsense. You either are a person who makes up wild, nonsensical stories about your history and certifiable or you are a short just trying a new tactic. I think it’s likely the latter. I guess you could be both.
Some of the effort seems to have come about in the changeover from EMA regulation to UK only regulation, via BREXIT, so while the UK government made legal preparations for the rapid deployment of COVID-19 vaccines through amendments to regulations, the approval process still required a thorough review by the MHRA, with the CHM providing advice on safety, quality, and efficacy. It seems rather they needed to create a framework for stepping out fully from the slower EMA process. Because Europe operates by consensus, creating more efficient processes are not as easy for the European system in place now, but the UK had the opportunity and necessity to address these matters regardless of COVID because they had just left Europe.
https://post.parliament.uk/regulatory-approval-of-covid-19-vaccines-in-the-uk/
Parliament did not push the COVID vaccine through over MHRA’s protests. Quit it with the nonsense. This is not the place for this anti-vax garbage.
For COVID-19 vaccines, regulatory processes were expedited to make vaccines available as quickly as possible to respond to the public health emergency. Since then, they have reformed and decided to broadly apply the new expedited regime. However, this expediting regime was never meant bypassing the MHRA or the CHM. In fact, amendments were made to the Human Medicines Regulations in 2012 to allow for temporary authorisation of an unlicensed product in response to a public health threat, but only if specific conditions of safety, quality, and efficacy set out by the MHRA were met. The MHRA, with advice from the CHM, was still responsible for reviewing and granting temporary authorisation for COVID-19 vaccines, ensuring that they met stringent standards through a comprehensive clinical trial program .
No, not imagining. Your words repeated back at you. And please, go ahead and explain why you spend so much time here. This is not Twitter. It’s a very obscure place. You imply you’re “top” of the food chain by your comment. I don’t believe it. But wherever you are in the food chain, you might as well be an arsonist. Your job here apparently is to light the place on fire and watch from the crowd as a concerned neighbor.
As far as the “food chain” goes, I am a shareholder with a voice. And no, shareholders are not officers or directors, that is the nature of Capitalism. Nothing new there. You don’t own any shares, or so you suggest. Where does that put you? Maybe you’ll buy a few shares for a few minutes as a fig leaf, to claim you’re a “shareholder advocate”.
This is false. It does provide meaningful life extension to numerous patients and the fact is that they do that already with drugs like Keytruda and similar, that often have no meaningful life extension whatsoever. But you keep trying.
You’re a determined, “I don’t own anything or short, I just post here 24-7-365, because this obscure board is ‘interesting’ kind of a poster. Quite obvious there is profit here for you in bashing the stock, and that denials undermine your credibility. But that’s the unfortunate way for shorty, gotta pretend to be something you’re not.
https://www.ajmc.com/view/fda-to-reassess-6-oncology-immunotherapy-indications-granted-accelerated-approval
And yet, in most cases, the FDA let those approvals stand and patients are still receiving those drugs through their national healthcare systems and insurance programs. Meanwhile this drug has very few side-effects and has actually shown not only substantial life extension and a breakthrough, in fact, according to doctors, not anonymous posters on bulletin boards, but even miraculous results when its mechanism of action is enhanced with some of these other drugs. Not a surprise to regulators because they recognize that immunotherapy is complicated and multi-layered.
This is very cryptic. Is CPP short? Where did that come from? It’s a national program. Would they really short biotechs that save people?
It doesn’t cause me “angst”, but when a kid comes and knocks down my mailbox or puts graffiti in my property, it’s definitely annoying. And when a mafia guy comes and says, it would be a shame if something would happen to my business if I don’t pay him protection money, and then he tries to burn down my business, you bet that that is even more infuriating.
What you and the shorts do is somewhere in that range of activity, pure vandalism and you make money doing it, and you pretend you don’t, you lie, like the mafia guy who might say to the cops, “No officer, it wasn’t a threat, I just was concerned his business might catch fire. But I never said pay me or else. Never. I would never think of saying anything like that.”
And when you hear that, sure, sure, it’s definitely vexing. But I pick companies that are undervalued for a reason. So for me you just create value opportunities.
And your claim is that you are where in the “food chain”? An MM? A hedge funder? What’s your claim, that puts you here taunting investors night and day 7 days a week, under different ID’s? THAT makes you “top” of the “food chain”? No, criminals are at the bottom, they just don’t know it yet. They should not flatter themselves.
It’s not all you’re saying and your very presence here non-stop posting the way you do without disclosing your true motivations is far from “respectful”.
Approval is believed likely not just here but at very well respected places by respected persons as likely. The only people who think otherwise are nameless personas, of of whom stalk and try to intimidate longs in bizarre ways and raise fake claims with any regulatory body they can, not signs of self-confident arguments, and Adam Feuerstein who seems to have lost his mental health somewhere along the way here, quite honestly.
I agree that some longs make predictions that even for me sometimes are a little over the top, but they have disclosed their interest and that is to be expected that some will be very enthusiastic. But everyone knows their motives. They are transparent and have put it all on the table.
Not so with shorties. This is one of many things that make their behavior quite despicable.
Universities do not put out press releases like this for drugs that are truly perceived to have failed, by any stretch of the imagination. The first drug is already approved. This will be less controversial than that one…
https://www.uclahealth.org/news/fda-approval-brain-cancer-alzheimers
Brown doctors would not have done this if they thought otherwise either:
It’s not about what might maybe happen in the future. Quit it with this nonsense. They have excellent data. No data from any trial for any drug or device in this space ever was “perfect”, but there are numerous drugs for this disease where the data was not only imperfect but really did not show a substantial benefit as this data does and those treatments were ultimately approved. Further, the mode of action does look like it can be even further enhanced with numerous other potential treatments and I guarantee that regulators see that as a huge and obvious reason to make sure this is approved and available, despite it never likely being said. They’re not automaton idiots like shorts would want us all to believe.
Maintaining this false sense of doubt is definitely a thing for shorts, I get it, you’ll lose a bundle if this gets approved because you di not want to have to cover and have a tax bill any time soon.
You honestly sound very familiar.
Old commenters never die, they just apparently create new personas.
Some people get excited. The regulators do want to get good treatments that are safe and extend survival to patients and doctors as soon as possible, so that is real “pressure” but not of the kind you’re suggesting. I think people are talking about different things perhaps.
The regulators are clearly working very hard to speed their processes up generally and do exactly what I said, get powerful, safe and innovative treatments through the process as efficiently and quickly as possible. That’s pressure! Self-driven but also driven by all stakeholders.
Exactly. Very expensive, serious side effects that also may need treatment and often not effective for all patients or even the majority in various areas of cancer. Yet it is a very important drug and insurance generally covers it. I am sure the insurance companies may negotiate their rates as well, to some degree. But it is still very expensive. DCVax-L, I believe, will be provided in a community setting. It has virtually no significant side-effects and a substantial number of patients have a significant benefit from it. Add poly-iclc and we might get arms like the one in the yet to be published in a peer review article, where 4 out of 4 are still living, 1 over 9’years and 3 over 10 years.
No one expects MHRA or NICE to not do their jobs. That’s ridiculous to even suggest.