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Marzan, will you please translate "hadnle"?
Thanks, Ex - my boob, I stand corrected.
When I look more carefully at the original article, I see that 60 days relates to Palladium-103, not Cesium-131
Localised radiation might adversly affect DCVax-L sensitised T-Cells, reducing their ability to kill the tumour cells and may even jeopardise their survival.
2 questions need to be answered.
1] Is anything known about the effect that such a localised source of radiation would have on immune cell function at the site of the radiation?
2] How long does it take for the radiation produced by the cesium-131 (half-life 60 days) in the "tile" to fall to levels that are not inimical to immune cell function and survival?
I suspect that such localised radiation might deleteriously affect the integrity of DCVax-L programmed T-cells (?and Dendrocytes?) at the tumour site with the result that:
1] they would be killed or suffer functional damage caused by the localised radiation,
2] their ability to kill tumour cells would be impaired, &/or
3] at best, their ability to recruit unprogrammed immune cells to join the attack on the tumour ("recruitment") might be impaired and, at worst, it might be lost altogether.
In my line of business = Bowels Open
1] You wrote that "if the trial failed the article will be solely published by Dr Liau" . Pedantically, a journal would publish the article so that the only meaning that can be ascribed to your statement is that the sole author would be Dr. Liau.
2] Since you seem to understand comic books better than science, Dr Liau built the foundations for DCVax and then she allowed NWBO to construct its trial on that secure foundation. (Suggesting that a comic book hero called "ACE Ventura" has anything to do with CERN concerns me - has fact and fiction become entangled in your brain?)
3] I think it likely that DCVax works but I am concerned that NWBO are having difficulty in constructing an incontravertible case that shows that the trial has been so successful as to guarantee a slam-dunk acceptance by the regulators without the need for a further study. It would only have to supply a PR announcing failure within 4 days of having come to its own conclusion that the trial had failed based on its own inability to construct an incontravertible claim. This would be irrespective of how long it might take before it reached that conclusion.
Why do you assert that Dr Liau will be the sole author? She did not conduct the trial nor have any input into its running. I doubt that she had anything to do with the design of the trial beyond advising that it should be a double-blind placebo controlled study. I doubt that Dr. L. was privy to any of the decisions made to do with the running of the trial and consequently she will not be competent to explain any of the why's & wherefore's of the trial.
NWBO is the sole organisation responsible for every aspect of the trial's conduct (undoubtedly with some input from the various regulatory authorities) and it will surely be the Company's responsibility to arrange any and all journal publications relating to the trial.
Anders, unless I've misunderstood the import of what you are saying, it is to be expected that whether the trial has failed or not a learned article in a top-flight journal will result.
If the trial is a success people will need to see how much of a success it has been and where the results are pointing for future developments.
If the trial is a failure, people will need to see why and how it failed and whether there is anything advantageous that can be gleaned from the failed trial.
So either way, expect an article in a learned journal.
Anders, I cannot think that there will not be a publication from this trial since a negative result will be just as important (but not as welcome) as a positive result.
If, when the statistical analysis has been done, it fails to show any statistical benefit over Standard of Care, (ie DCVax-L is no better than grapefruit juice) it is vital that other researchers have all the information relating to the trial so that they can adjudge why the trial failed. Was it because DCVax didn't actually work or was it that the design of the trial turned out to be too weak to demonstrate that it had partial effects either in the entirety of the disease or in subgroups of the disease?
If the former, (no better than grapefruit juice) there would be no point in further investigations but if the latter, it might be that DCVax has a niche market to be elucidated so that some patients at least might be helped.
If a negative result is not published in its entirety, questions will quite rightly be asked about the suitability and even honesty of NWBO's management and investigators, based simply on the question "What have they got to hide that they haven't reported on the negative result of the trial?"
I presume that NWBO is not going to make a public announcement of the TLD until the article for the learned journal is completed, sent to the journal and accepted for publication. On its acceptance, NWBO can announce the TLD or as much of the TLD as the agreement with the learned journal permits, announcing the entirety of the TLD when the paper appears in the journal.
This is only supposition.
At least we know for certain (??) that a journal presentation is the next step in the process
It does annoy me that these very positive preliminary results for DCVax-Direct have been known for nearly 9 years and yet nothing but nothing has been done to take it further. If it had I doubt that we would still be waiting to see if dendritic cell therapy actually worked or not as that result would have been known long ago.
Granted that NWBO did not and does not have the money to run more than the DCVax-L trial but surely even Big Pharma can see from this phase 2 study that DCVax-Dir has a greater potential than -L and that a trial would be much quicker in garnering the requisite number of patients. Instead either BP doesn't give a hoot for an actual cure or NWBO has decided not to allow any other company to conduct a trial of -Direct.
Whichever it might be, over the last 8-9 years innumerable patients with inoperable solid tumours have been denied the probability of longer survival or even a possible cure because nobody has picked up the reigns of a DCVax-Direct Phase 3 trial which nearly a decade ago NWBO dropped because it could not (and still cannot) afford it - and might never be able to do so.
It explores the gut biome (aka sh*t) so understandable to think of NWBO, but not this time!
It doesn't look like its going to be in the next edition of "The Lancet" (see the contents page at https://www.thelancet.com/journals/lancet/onlinefirst)
nor in the March edition of "Lancet Oncology" unless it's included in the next few days.The contents list of articles so far included is to be found at
https://www.thelancet.com/journals/lanonc/onlineFirst
Gary, I hope you're right. Waiting for the result is like waiting to hear what the biopsy report says!.
Best wishes.
Addditionally, the monthly published "Lancet Oncology" (more likely than the Lancet to be the choice of journal) will fast-track peer reviewing of articles it considers important and will aim to get the article published within 8 weeks.
Kaizenman: Sorry, I have no knowledge nor experience of matters relating to how long articles take to appear in the Lancet nor notification to the author.
Although the Lancet itself is published weekly, I would think that something like the DCVax-L trial would more likely be published in the monthly "Lancet Oncology". The next one is the March edition and if you want to be notified of what is appearing in the journal you can register for free-of-charge notification of the contents on the day of publication at https://www.thelancet.com/journals/lanonc/issue/current
With regard to publishing articles in the journal, Lancet Oncology informs that:
Nothing in today's "Lancet" of relevance to DCVax-L
....and yet DCVax-L is not mentioned by name in the components being studied whereas all the other components are fully named:
Biological: Dendritic Cell Tumor Cell Lysate Vaccine
Other Names: DC tumor cell lysate vaccine
dendritic cell-pulsed tumor cell lysate vaccine
DCVax-L not mentioned
Biological: Pembrolizumab
Other Names: Keytruda
Lambrolizumab
MK-3475
SCH 900475
Drug: Poly ICLC
Other Names: Hiltonol
Poly I:Poly C with Poly-L-Lysine Stabilizer
poly-ICLC et al
DCVax-L is only mentioned in the context of study patients having been previously enrolled in the NWBO study:
Not quite the Horn of Gondor - this is Boromir calling for help just before he was cut down by the Uruk Hai.
I hope this is not an analogy for NWBO's current situation.
.. traditionally known as a "murmuration" of Starlings
Well, it looks like he at least has got the bare bones of the Top Line Data but appears to be keeping it under his hat.
My late brother, a Lawyer, was told the following back in the 1960s by his elderly mentor, a Lawyer "of the old school".
"A client was surprised one day to receive a bill from his lawyer which read, "To crossing the road to greet you and finding it wasn't you - 1 guinea". (a guinea was an old gold coin worth one pound and 1 shilling (£1-1s-0d), or 21 shillings, equal in today's decimal currency to £1-05p. The Guinea still lingers on in the name of some horse races such as "the 2,000 Guineas" at Epsom etc, that being the prize money
Hear, hear.
Silence is not golden.
Happy; That is natural paranoia - the firm belief that no matter what you do, the Universe is out to get you how ever it may.
Thanks, Anders.
I appreciate that there is a 4 day rule but at what point do the 4 days start? That is, perhaps, the driving reason for my disquiet. If this trial had ended in a clearcut, undoubted success in all areas I have no doubt that by now the news would have been plastered all over the place. Instead, all we have is silence with nothing to even hint at why.
I don't doubt that Management is honest, but they are, after all, human. Like everybody else they don't want to fail, especially after they've had to fight so hard and long against shorters and low-lifes like AF. Unless there are rules against it, I can imagine the statisticians having to go statistically through every single subset of tumour morphology, enzymology and genome in a search for something to call a success. If that were allowable it could go on until there was no unexplored corner of the data left and only then would they be forced to accept "Failure" and announce it within 4 days.
Idunno,
Thanks for your helpful reply; you've put my mind at rest. I'm not an inveterate investor and have stuck to the very basics. I failed to realise the significance of the warrants being suspended and I am now very much less concerned that the trial has ultimately failed.
However, I am still not back to my previous level of confidence in DCVax's efficacy. I am still concerned about the length of time that the company (and ?statisticians?) are taking to complete the steps to announcing TLD. It strikes me that it has been more difficult for the statisticians to show DCVax in as good a light as I hoped - "Yes it works, but not as well as we all thought". But that is no reason to sell.
I have believed in this product since I first invested in it 8 years ago. I have, therefore, excused the stupidities and mistakes and apparent self-serving actions of management in the belief that the product will eventually succeed.
Now, with the promises and hints and encouragements both from Management and some of the more notorious supporters of the product on this board all failing to materialise since lockdown and the statistical analysis commenced, it is beginning to smell that there is something nasty in the woodshed. By aggressively increasing my stake whilst the SP languished in the 20-25c range (I never seemed able to buy anything sub-20c) I eventually ended up with my investment averaging 28c/share but I am now seriously considering cashing in my chips and taking the handsome profit I've already made (although it has virtually halved over the last few months as deadlines have repeatedly not been met and statutory documents haven't been issued on time or at all).
I could hang in for a wee bit longer but at what I feel is now an increasingly likely risk of the company announcing that despite all the euphoria and pumping the trial has in fact failed.
As somebody who was born long enough ago to remember food rationing and childhood friends dying of polio, and who has consequently lived long enough to develop a significant waistline and high blood pressure (not helped by the aggravation caused by the actions of this bunch of "managers") and now with Covid-19 swirling around my ears (but not yet through my body), I hope TLD occurs before E.O.L. but at this rate I am by no means certain that it will.
Ah well, at least I may leave my chidren and grandchildren a sizeable nest-egg.
The link still doesn' work with the Times web-adddress that you specified. Is the address
"https://www.thetimes.co.uk/article/cat-allergy-failure-leaves-scratches-all-over-stocks-guru-" complete as it terminates with a hyphen suggesting that there might be more to the address?
Since this entire enterprise is a fake, a fraud, a scam et al I take it that you've played safe and sold out either at a profit or perhaps at a small loss. If not, why not?
Kab, he clearly desn't understand the difference between "median" and "mean". Unless he can come back with an exceptionally erudite explanation that supports his position he can be dismissed from further consideration because he is ignorant of even the most basic of facts.
I suppose that being on double zinc leaves you galvanised for immediate action.
Foxhound, is TPD a typo for TLD? If not what does it stand for?
... then why not announce such important news instead of waiting until all the "i"s are dotted and all the "t"s are crosssed? If DCVax-L can cure GBM this is news that shouldn't be kept hidden until the management decide the time is ripe.
Foxhound, is this a convention or a stipulation?
If it is just a convention that nothing is released until everything can be released, one has to ask the question, "Why?"
If it is stipulated somewhere in the rules that nothing is released until everything can be released, the question is stil, "Why?"
In the matter of Clinical Trials I may be somewhat naive and simplistic so that all these delays in announcing whether DCVax-L works or not makes me wonder just what is going on.
We now have a completed Phase 3 study, one whose end-points is Overall Survival (O.S.) which now is compared with historical O.S. using "standard of care" to see whether O.S. is prolonged by treatment with DCVax-L by a statistically significant amount.
That should pose no problems at all. The endpoint, death, is an unambiguous, clearcut point in time. Matching up the length of survival with the duration of DCVax-L treatmnt and comparing those results with the historical survival data for S.O.C. should present no probems at all, so why the delay in announcing the main result of the trial?
Does DCVax-L work in prolonging life or not?
There may be other facets of the trial which need analysis, such as whether delayed treatment with DCVax-L has a deleterious effect (crossover patients who in retrospect had pseudoprogression); whether the methylation status and other similar subsets of the basic tumour are affected differently by the treatment and this will take time, etc. But, should that delay announcing the main result?
This continuing delay in announcing the main result which must be known by now (and if not, why?) is beginning to concern me, a long-time holder of 8 years. Is the delay because overall the trial failed and the analysis is now centered on whether it is effective in any subsets of GBM - methylation, etc. - so that at least a licence for use in that particular subset might be attainable.
Answer, please.
With the brin tumour cnultant being at Kings College, London and the accine being made at Sawston ("Cambridge") I doubt that the Germans are involved at all.
With the tumour consultant being at Kings College, London and the vaccine being made in Cambridge (Sawston) I doubt that Germany comes into this at all.