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Thanks so much WideEyed! I find this site so hard to locate posts generally, once you post them. I should have saved t myself. You’re a lifesaver!
Thanks Chiugray. I thought he has, despite immense challenges, always been fair. I agree that one cannot say 100%, generally, but I like the odds as well.
A few weeks ago. One of my rare posts where I talked about market size and potential market caps. Had a fair number of comments. It was posted specifically in response to the notion that shorts love, "but the UK is so small"....
My market size post related to the UK was taken down. Not sure why. It was completely on point, not about anyone else. But it is not locatable. If anyone else finds it, maybe I am incorrect, but it speaks to the issue with regard to some forums, the frequent impermanence of positive articles about the company.
Probability of approval, interesting article. Worth a read.
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=173645036
That is not about progression doc and you’re describing treatment for both treatment arm and non-treatment arm placebo. On recurrence, there was no required non-treatment protocol or requirement that doctors not determine if true progression were occurring. This is one of a few legs upon which Ex’ claim fails. Moreover, the placebo arms that recurred. In the concurrent trials were selected to have the same prognosis, after receiving the same care. So living longer on receiving DCVax-L is still statistically relevant.
As for our friend, he just tries to make this all seem much more complicated and obscure than it has to be to cloud understanding. And of course he is not in medicine nor a doctor nor an epidemiologist or statistician. At least that has never been claimed.
I don’t pump. I just ask people things like, what is your interest and why do you spend 24-7-365 bashing on this obscure board when you do not own it. This honest question irritates people like you who do not disclose their interests and you call THAT “pumping”. You call it “pompous”… but really, you simply refuse to disclose and you hate being asked to be transparent like those of us who disclose our interest in EVERY post.
Most of the time it is because such people are vulnerable, large shorts and they work at firms… that short. And disclosing that would open a can of worms…licenses and other things being what they are…
He says a lot of things. He is inconsistent. Never the same story from post to post to post… and far too much emotional insanity. Nothing justifies his behavior or crazy tone. Far beyond normal. Unstable.
Now in this post you say you “once owned it”… again, seems like these posts are incredibly unreliable in terms of the disclosure of your interest…
I note you said here, “AND” I own IOVA…
And this post seems intended to confuse…
And you post on this obscure board for what reason? You’re promoting IOVA?
That doesn’t seem to be your purpose. You just like to waste your time and ours? Seems unlikely too given the persistence and the extreme emotion you express here.
Let me state this more clearly, because I was thinking it through as I wrote it.
Not necessarily the statement is for purposes of the initial determination for the trial involving nGBM. There is no such limitation on the diagnosis for rGBM.
For the determination of recurrence the trial was required to be consistent, for statistical purposes, even though it was learned during the course of the trial that the standard method alone was flawed and not valid for pseudoprogression. This is an unfortunate part of the ridiculous formality of trials, that you’d have to continue to diagnose in this manner, in order to remain consistent, knowing, in fact, that you’re getting a false result. It is not the requirement for patient care and it would be medical incompetence to presume recurrence when you know it hasn't happened. Further, that is really only for patients in the nGBM context. Upon recurrence, doctors would certainly do their best to be sure that was the case. Further, such patients this applies to, this analysis, are ONLY the STANDARD OF CARE patients, NOT the treatment arm. Pseudoprogression was a problem primarily for immunotherapy patients. But again, there is no limitation on diagnosis and scanning for rGBM patients after they've recurred, that would be a bizarre situation and unlikely given the many care centers and doctors participating who generally have no interest one way or the other. You might presume the doctors are incompetent with the standard of care, placebo patients, but it's highly unlikely.
Once the patients were diagnosed as recurrent, it would be medical malpractice to diagnose such patients as “recurrent”, when they were not, in fact, recurrent, if you have the knowledge to diagnose that they are rGBM.
There was no original protocol for the rGBM patients, so they will discuss that I am sure with the regulators. However, there is also no reason to doubt the survival results compared to patients with the same or similar diagnosis in trials that happened concurrently. The reality is, they were compared to similar patients with similar diagnosis in concurrent trials. There is no difference in that circumstance. And again, these were the placebo arm, standard of care patients, where pseudoprogression was not typically seen previous to immunotherapies.
Remembering that pseudoprogression difficulty in diagnosis happened in the treated arm for immunotherapies but also that limitations as to diagnosis are only for statistical collection, not for care, helps to keep one honest. Once patients recurred, they could get all kinds of additional care, including Optune, and that is registered in the details presented in the JAMA paper. The rGBM patients were getting the standard of care only, so pseudoprogression likely was not the issue it was in the treatment arm and even if some of them are, again, you’re comparing to patients in a standard of care, getting the same exact care, in concurrent trials. No difference. So the survival results are comparable.
This only works to confuse people who cannot think this through.
Not necessarily the statement is for purposes of the initial determination for the trial involving nGBM. There is no such limitation on the diagnosis for rGBM.
For the determination of recurrence the trial was required to be consistent even though it was learned during the course of the trial that the standard method alone was flawed and not valid for pseudoprogression. This is an unfortunate part of the ridiculous formality of trials, that you’d have to continue to diagnose in this manner, in order to remain consistent, knowing, in fact, that you’re getting a false result. This is what shorts are most consistently about. And the company maintained that for purposes of the diagnosis of recurrence for nGBM.
However, once the patients were diagnosed as recurrent, you do not know if additional review of their disease happened, but that seems awfully likely. It would be medical malpractice to diagnose such patients as “recurrent”, when they were not, in fact, recurrent.
There was no original protocol for the rGBM patients, so they will discuss that I am sure with the regulators. However, there is also no reason to doubt the survival results compared to patients with the same or similar diagnosis in trials that happened concurrently.
Further, remember that pseudoprogression difficulty in diagnosis happened in the treated arm, the rGBM patients were getting the standard of care only, so pseudoprogression likely was not an issue and even if some of them are, again, you’re comparing to patients in a standard of care, getting the same exact care, in concurrent trials. No difference.
You claimed just a few posts ago that you own shares... so you just called yourself a loser. But again, no one in their right mind can believe you because you clearly tell incredible lies with great emotion, which is why they are so incredibly obvious. Further, you spend ALL of your TIME here with LONGS, trying to convince LONGS with obvious deception. There would be no need to do so if 1) you actually held shares; or 2) this is a failed company. You would not need to do it if your interest were not completely counter to longs. As I said, your lies are so obvious, and yet you continue, and it's tiresome because we know they are not meant for us, they are meant to influence stray visitors. We know you're lying. You know you're lying. You know we know you're lying.
What happened is obvious. I don't need to speculate. The regulator would not have allowed them if any of it were untrue. As to whether it will be approved, I think it is HIGHLY unlikely that a safe treatment, for an orphan disease, with the kinds of results that they can show across the board in many patients, side trials as well as this trial, with patients living way longer than anyone sees ever... it's unlikely it gets rejected. That you think it will be I think is bizarre and unhelpful and then to say you've got shares and pretending to be a fellow long... it's obviously unbelievable. Anyone who so obviously lies, cannot be trusted with regard to their claims about what will happen and what has happened. No one in their right mind would believe you.
That’s not what happen d and they were working with their regulator. OS was always a secondary measure, the problem was the regulatory mandated crossover that depleted the control arm, not the measure, and the regulator came up with ways to address this, with external control arms. Fixed notions about bias are also easily dealt with the they came up with, likely in complete coordination with the regulator, hiring outside noted statisticians and epidemiologists who were third-parties and maintained complete blindness.
The reality is, short throw pebbles and you sit with shorts throwing those pebbles virtually all night every post, except when you protest that you “own it”, just like every shirt that needs that legal fig leaf to claim they are a “shareholder advocate” and not manipulating share prices for easy money.
Swing traders and short hedge funds “own” it too, doesn’t make them the same as a long. “Own it” is particular language.
Nonsense.
No, survival is NOT a shortcut. And a new trial wastes lives, money and entire companies and the FDA is reformed to avoid exactly that kind of unnecessary, false traditionalist nonsense that has absolutely no point but to keep only the largest companies in the game.
For taxes.
No one lies. This is your claim and if they did, sue them. Lying is a crime. Alleging they lie, lying, without proof just to affect investor interest aught to be a crime too.
All facts in my post. You have nothing but to shrink and pretend.
Quit bluffing, it was a phase 1 / 2 safety trial, no safety issues. They found systemic response and many patients surviving far beyond when they were supposed to survive. But it was not calculated to give an optimal treatment, as a safety trial.
The patients were unable to get other treatment and were effectively assigned to go to hospice if they could find no other options. They only injected one tumor even if the patients had many. The result was most patients lived longer than expected and some seem to have continued living indefinitely. They had a variety of horrible cancers. They gave different amounts I believe, and different versions of the vaccine.
“Primary Outcome Measures:
Number of patients with adverse events [ Time Frame: 6 months ]”
“Subjects with a histological or cytopathological confirmed diagnosis of a locally advanced or metastatic solid tumor malignancy for which primary treatment is no longer effective or does not offer curative or life-prolonging potential per clinician judgment, with the understanding that DCVax-Direct is not intended as a treatment of last resort.
Not eligible for complete resection due to either tumor location, physician's assessment or subject's choice.
Must have completed at least one recent treatment regimen in the metastatic or advanced setting in the disease currently under treatment to reduce tumor burden.
Any steroid therapy >2 mg dexamethasone or equivalent dose should be stopped or have been tapered down 2 weeks prior to the leukapheresis.
At least one measurable tumor mass, i.e. a lesion that can accurately be measured by CT/MRI in at least one dimension with longest diameter = 1 cm, that is accessible for injection either with or without imaging (CT/ultrasound) guidance.
Adequate hematological, hepatic, and renal function,
Adequate blood coagulation parameters
Life expectation of >3 months.”
“Abstract
Purpose: Dendritic cells (DC) initiate adaptive immune responses through the uptake and presentation of antigenic material. In preclinical studies, intratumorally injected activated DCs (aDCs; DCVax-Direct) were superior to immature DCs in rejecting tumors from mice. Experimental Design: This single-arm, open-label phase I clinical trial evaluated the safety and efficacy of aDCs, administered intratumorally, in patients with solid tumors. Three dose levels (2 million, 6 million, and 15 million aDCs per injection) were tested using a standard 3 + 3 dose-escalation trial design. Feasibility, immunogenicity, changes to the tumor microenvironment after direct injection, and survival were evaluated. We also investigated cytokine production of aDCs prior to injection. Results: In total, 39 of the 40 enrolled patients were evaluable. The injections of aDCs were well tolerated with no dose-limiting toxicities. Increased lymphocyte infiltration was observed in 54% of assessed patients. Stable disease (SD; best response) at week 8 was associated with increased overall survival. Increased secretion of interleukin (IL)-8 and IL12p40 by aDCs was significantly associated with survival (P = 0.023 and 0.024, respectively). Increased TNFa levels correlated positively with SD at week 8 (P < 0.01). Conclusions: Intratumoral aDC injections were feasible and safe. Increased production of specific cytokines was correlated with SD and prolonged survival, demonstrating a link between the functional profile of aDCs prior to injection and patient outcomes. Clin Cancer Res; 24(16); 3845-56. ©2018 AACR.”
Not true. Novel claims often require a complex back and forth with a court and defendants before the course of a case is fully set in motion. They are going for something that has not been done before and I believe they will be successful. But the reality is that bold claims can require some back and forth like what is occurring.
Like before it went to $12?
Your insistence that validation does not exist, despite the evidence that it does, and the nature of the trial, disease and apparent very favorable leanings of the U.K. given access in the specials program, is no surprise. It’s just that you have been consistently wrong, in such matters and all you have is really old nonsense.
No, but I would not expect anything other than something so vulgar and excessive as your opinion.
I am not supporting or attacking him. Your behavior is nonsensical, bizarre and has no logic and you’re attacking the orderly structure of a company in which I am invested.
I am not here to facilitate bizarre or bad behavior. And I am here only as another investor. Not here to advocate for you to be invested. If you don’t like something, you don’t have to be invested. No one is begging for you to be invested.
Actually, I did go through the ownership details. I clearly know way more than you. You’re just throwing around false implications and nonsense. Bizarre behavior.
Your knowledge is not critical to the internal decisions of the company on such matters. Some of his shares may not have been allocated your attack on this, randomly, bringing up things unrelated from 2007, when he was not a board member and involving regulatory matters, clearly you’re screaming all over the board without ANY actual information, which is bizarre. Seems like a fake effort to create noise around trying to oust a board member. And that, as I said, usually suggests interests trying to get some sort of leverage. But, in this case virtually all the points are without real information, are falsely made by implication, not facts, are extremely dated, and are literally bizarre. Strange. Not rational.
The Swiss thing was not a “deal”, and he would not have been involved as an analyst. It was a regulatory application.
It also happened in 2007, before LP was an officer and really she took over after that.
Your post digs deep, in terms of years,connects things that are not really connected and attacks board member basically out of the blue.
I am presuming there is some undisclosed motivation. Usually this kind of nonsense suggests an effort to make a move on a company. But in this case, poorly executed.
You can find out by doing your due diligence. I am not here to help people who undermine the company.
You have nothing new!?
That is all water under the bridge. Old news. Not currently relevant. The result of short manipulation and an effort to take over the company most likely on the cheap. Sounds like there might be another attempt…
You guys part of the takeover on the cheap?
Nonsense. It was long ago. It was clearly a mistake of an inexperienced team and before LP took over the CEO position and management of the company. It was a doctor who did not understand Switzerland, and as I explained, the Swiss are something else and often make broad claims that are not accurate when try g to induce people to do business in their country. I love Switzerland. Beautiful country, but very narrow. The cantons think they are their own countries.
When you get compensation in shares, you have taxes. There was an allocation and a lawsuit. I doubt there is any secret involved here. And, by the way, you can sell shares to pay taxes even if they are not from the allocation. But I believe his taxes are related to his shares from the company.
Again, you’re not saying anything for real, just implying things.
My pleasure Gary.
Owning shares does not make them “not independent”, it aligns them with shareholders. And as for your speculation, you haven’t said anything yet, just implied things.
No, I am just saying what I know. I am aware that when he was an analyst he was understandably excited. And then the company, that is 2007, just before the financial crisis, hit a financial challenge just like countless tiny bios at the time. Many went out of business entirely, even with trials and promising drugs still. So, you can pretend to be saying something, without context, but the reality is, you are opening a door that if I were him, I’d make you walk through completely.
For taxes. It’s clearly stated in his disclosure.