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Absolutely. This is coming to a conclusion, whether it be a week or 2 months.
And it is not the company doing any can-kicking.
The news blackout for the last few years has frustrated shareholders, but it has also stymied the professional (term used loosely) critics such as Wick, Stupp, and Floorstain.
So it's important how TLD is presented, because these guys will react.
Even more so, when full data exposition takes place at a suitable time and place down the line.
Thankyou, Ev.
I always enjoy a bit of etymology.
Let's hope it's only a temporary kybosh or spanner in the works.
Of course, it's totally bad news if you happened to be a patient who was on the verge of accessing DCVax-L this way, just before the balloon went up and the curtain came down.
And if it is soft lock, then that begs the question as to whether they will work right through to a topline announcement, on the basis of that soft lock.
For me, it depends what's missing.
If it's only IDH status for a few patients I don't think it really matters.
IDH status has no material bearing on the endpoint data analysis. It's really only an addendum, imo.
But if it's anything else, such as all the data for maybe 10 patients, then soft lock doesn't really take us forward.
You can't (or shouldn't) PR topline data if you are missing critical PFS and OS data for a few patients.
You would just be inviting criticism from the well known critics.
Evaluate. Thanks!
I was confused.
And now I am bamboozled.
Sorry Vator; it's not really at all clear.
Is it soft lock or hard lock in 10 days?
The way I read it, it's soft lock.
But it could be hard lock.
Or is it semi-hard lock?
In every sentence, it's impossible to tell if they are talking about soft lock or hard lock.
Which means hard lock could be some time down the road.
I would like weekly updates from the company and clarity.
Yes, clearly a typo.
But a typo that leaves the intended meaning somewhat in doubt.
What do they mean by a 'material change'?
Presumably meaning that at the end of the day they will be liable for a big whack.
But it could also mean that at the end of the day there will be no liability at all.
I think they probably mean that at the end of the day, they will more likely have a sizeable liability than not.
But I'm only guessing.
I shall have to stop pedantically picking them up on these grammatical faux pas, because in the scheme of things, this tax issue is somewhere between small fry and a vegeburger, whatever the statement actually means.
So all good really, other than the Covid-related stuff, (which is preventing UK Specials currently), and Covid-related stuff shouldn't be laid at their door, or used as a hammer to bash them with.
But hard datalock is what will ultimately bring a collective sigh of relief.
No intentional aim to wait for OS60 data before datalock.
Everything is as expected. No delay or can-kicking by the company.
Covid delays predominate.
It's put the kybosh on UK Specials since March and that continues.
I will relax when full datalock is achieved. That would be the end of CRO tasking, and the company resumes control.
Does datalock at end of next week mean soft or hard?
Company needs to clarify.
Soft means a further time period until hard (nothing like stating the obvious..)
So despite the company pushing on as much as they can, it would appear actual hard datalock might be a while yet.
But. The main takeaway is that the trial is coming to an end. Final datalock will happen. TLD will happen.
(They could have PR'd half of this last week, and saved themselves some grief. Going quiet at this critical stage is counter-productive.)
Further update every week please.
That initial post with the Del Bigtree video referenced Dr Hotez, Dr Sanjay Gupta, and Dr Paul Offitt! All who strongly advocated for proper rigorous trials to ensure safety and efficacy...
These people could in no way be described as 'anti-vaxxers'!
Del Bigtree advocated for all the Covid vaccine candidates to be properly randomised and properly placebo-controlled. After all, that is precisely the process that DCVax is going through.
This contrasts with other immunotherapy trials that have led to approvals. Trials that are often single arm, open label, or use inappropriate controls.
And he calls for all vaccine adverse events to be fully recorded and documented for a minimum of 1yr for adults, 3yrs for children, and 5yrs for young infants.
Sounds eminently sensible to me, when the intention is to vaccinate the entire world.
When the message is constantly hammered home that there is going to be no return to a prior normality 'until a vaccine', it does rather beg the questions: Will the vaccine be safe, will it work, and will the consequences of receiving it be worse than the disease?
That's pretty much the questions that I ask about any drug.
Why would anybody not ask those questions??
I don't discriminate about vaccines (though it has to be said, as a class of drugs they have a very poor record).
The fact that DCVax is called a 'vaccine' is really just a quirk of history. And it deserves the epithet of being a therapeutic vaccine.
It has been proven entirely safe, doesn't cause auto-immune dysfunction, or cytokine release syndrome. And that is most certainly related to its autologous origin.
But you couldn't say that about the ICI's or the Car-T's...
So for me, it's all about evidence-based medicine.
The risk of vaccine-related immune enhancement and Th2 immunopathology is very real, not imaginary.
Here's a good balanced article on some of these issues, which quotes experts with varying views on how these risks might apply in the case of a Covid-19 vaccine.
From the article:-
Good spot, Jack.
Funny how this li'l old site is now the subject of international reporting from the likes of Reuters and the NY Times!
And who actually leaked that they are going to get approval?
Are they really going to spend a further $0.5 Billion on the site?
That's a lot of dosh in anyone's terms...
Huawei might regret giving NWBO the secure tenacy.
And it won't harm the value of the 17 acres at all.
Well, perhaps they are trying to claim a rebate!
What are you suggesting?
That a German tax issue is a red herring?
Yes, well it's quite plausible that they have been hit with a tax bill from Germany, whether it be in respect of past earnings from patient treatment, or indeed something else.
But then the question would be; why don't they just get on and pay it, and be done with it?
They would surely do that if the amount was relatively small.
By that I mean under about $40k. Once you get above about $50k, then you might be in the realms of disputed liability, a process which could drag on for yonks.
But is the tax issue actually the substantive reason for the non-appearance of the 10-Q?
That remains to be seen...
Taxation of foreign companies in Germany:-
https://www.lawyersgermany.com/taxation-of-foreign-companies-in-germany
Ex. Do try and keep up.
France has banned all community physicians from prescribing for a long time now. So you end up with a high percentage of cases that needlessly end up with advanced disease and needing hospitalising, with a consequent much worse outlook.
Same could be said about the UK. (Mild symptoms, isolate at home, do nothing, no early treatment and not even tested.)
Prof Raoult at the Marseille Hospital (which is the number one French hospital for infectious diseases in all of France) can prescribe, because of the hospital setting. Of all the patients he treats (getting on for 10,000 now), he can prescribe on an outpatient basis as well as to those who are admitted.
Of all those he sees and for whom he uses his protocol, he has a CFR of 0.5%.
Of those who are admitted, the case fatality rate is 5%.
The UK hospitals involved in Recovery (terribly inappropriate title..) have a fatality rate of 24-25%. Getting on for 5 times.
And in Marseille the CFR for ICU is 15 or 16%. I haven't got a UK equivalent but it is probably at least double that.
And if you get to the CRS / ARD stage HCQ isn't going to help anyway.
But that's the whole point; HCQ (plus azithromycin and / or zinc) prevents 90% ever getting to that stage.
And of those who get to the critical stage, 90% of them will be over 70, probable co-morbidities, and probable immune deficiency.
Prof Perronne (Professor of infectious and tropical diseases at the University of Versailles-Saint-Quentin-en-Yvelines, also appointed head of the infectious diseases department at Raymond-Poincaré Hospital in Garches).
In 2009, he was Vice-President of the European Advisory Group of Experts on Immunization (ETAGE), which advises the European Health Organization’s European vaccine policy. So not an opponent of vaccines per se and he chairs the Commission for Communicable Diseases of the High Council for Public Health.
An expert in other words.
And he estimates that 20-25k of the 30k fatalities in France were unnecessary, because of the French govt stance on disallowing community use of HCQ.
https://fr.news.yahoo.com/coronavirus-professeur-christian-perronne-eu-190822111.html
Any country that has has more than 10% deaths to cases is likely to be a country that doesn't use HCQ.
Check it out!
And while you're at it, can I recommend this video:-
This whole issue is directly relevant to NWBO and their advancement of a potentially disruptive platform treatment.
And when I say 'disruptive', disruptive is the operative word!
It could, in time, represent a disruption to the established order in cancer treatment, and the pre-eminence of those BP guys.
Anyway, on the information war:-
Why should ruling elites be allowed to speak with 'unvarnished honesty' in private forums?
We can probably never avoid having 'elites', but 'ruling elites'?
Unelected elites shouldn't be allowed to rule.
Surely you wouldn't disagree?
Simple as that for me. Especially when they are shaping policy behind closed doors.
It's the antithesis of democracy.
It was Richard Horton himself, who made the now infamous remark about half of all scientific literature perhaps being false, in his commentary piece in the Lancet back in 2015.
Full piece here:-
https://www.thelancet.com/pdfs/journals/lancet/PIIS0140-6736%2815%2960696-1.pdf
Of course he was talking about scientific literature in general.
He wouldn't be daft enough to say that half of everything in the Lancet itself was false!
But if he believed what he said in 2015, perhaps he should have worked harder to ensure that the Lancet bucked the trend he was talking about, and tried to maintain a reputation for quality, honesty, and rigour.
And the publishing of the Surgisphere 'paper' on HCQ amply demonstrates that the Lancet simply doesn't deserve its lofty reputation, in my opinion. That was supposed to have been 'peer-reviewed'. And the NEJM is just as bad, because they published the other Surgisphere paper (which I assume was equally rubbish). And when the whole Surgisphere thing was rumbled, both the Lancet and the NEJM issued 'letters of concern' and subsequently fully retracted within an hour of each other.
Surely if Horton had honour he would have resigned by now.
The open letter signed by the researchers from around the world (over 200 in the latest version) apart from demonstrating that the paper had to be false, stated or asked the following:-
All the long term survivors in the trial started out on TMZ.
And we know that probably 50 or more had not had a disease recurrence by Spring 2019.
That makes life a lot easier and better.
Left field choice:-
Just wondering when we finally get to the release of topline data, how long it will take for Messrs Stupp, Wick, and Feuerstein to be wheeled out to rubbish it.
Or will they wait for full data exposition at a subsequent conference (virtual or otherwise) for the full attempt at a hatchet job?
No, no no. Why would you want to give lifetime immunity?
Much better business to have an annual vaccine requirement with a threat of new house arrest.
Good point.
If Fauci was funding Wuhan, can't you petition to get rid of him on these grounds?
It ain't gonna happen though.
Lol.
Anyway these NIH guys should have known better. They should have known you are only allowed to accept bribes from Big Pharma, and not foreign governments.
Thanks Truthfan. This manufacturing was always on the cards as we knew they were part of the Oxford consortium, and now it's confirmed.
(The fact that AZD1222 will likely be no more effective than an out of date flu shot really doesn't matter, now that Govt's around Europe and the US have written cheques to AZN to the tune of a couple of billion!).
The Cobra manufacturing will almost certainly be at Matfors, Sweden.
Today Matfors, tomorrow somewhere else in the UK???
Noticed at the bottom:-
Woodford Equity Income assets (mixture of listed and unlisted) sold off for a song by the Fund administrator to a US vulture.
Hi 'Diver.
Personally, I think a second wave in the Fall/Winter just isn't going to happen. The virus is dying on its feet already.
New Zealand is in the middle of its cold season, and has virtually no cases.
I don't think Covid is weather/ temperature dependent at all.
SARS and MERS just 'went away' and never came back...
Each country or region goes through a wave, where case (and deaths) rise for a month, followed by a gradual and persistent decline.
It's the same pattern across the world.
All the fearmongering about a second spike if social distancing restrictions are lifted too early, is just that; fearmongering.
Primary schools have been back for 2 month in Denmark; no spike.
Spain and Italy are re-opening inward tourism. Deaths in most of Europe are now down to a tiny trickle, even as shops and workplaces re-open.
The wave in Mexico (Mexican wave?!) is at its height, but it will follow the same pattern as everywhere else in time.
As regards HCQ, the French experience is an eye-opening national scandal, similar to the UK. There is a strict ban in France on community doctors prescribing HCQ. And they have the worst cases to deaths in the world. Just under 20%. Shocking.
Prof Christian Perronne is just about the most eminent expert in infectious diseases in France and he is speaking out about the scandal. In his estimation, 25k out 30k Covid deaths in France could have been avoided had widespread use of HCQ (ideally with Zinc and / or Azithromycin) been employed at first symptom stage.
Here he is interviewed:-
Any reference to mesenchymal patients does not refer to patients in this trial.
Small correction Marzan. LL has never said anything about patients in this trial being mesenchymal. It's the 3 yr survivors that have a majority that are free of progression.
You might have meant methylated rather than mesenchymal.
It's true that a great majority of 3yr survivors are meth.
Senti. My apologies.
Why did I see it the wrong way?
Now I read it again, it's quite obvious you were being sarcastically facetious (or even facetiously sarcastic)!
Here's a doctor from your part of the world, describing the current reality on the ground:-
It will be two weeks on Monday that the company gave us a PR update, about possible things getting in the way of a timely datalock.
Well, my current thoughts and viewpoint on HCQ has been reached without any political affiliations or leanings at all!
On such an important issue, where hundreds of thousands of lives are at stake, it would indeed be tragic, if views and indeed treatment availabilities, were based more on political affiliation than on the available scientific evidence.
Now, anybody can weigh up available scientific evidence for themselves and reach their own conclusion. That's as long as all the evidence is freely available in the public domain. Which unfortunately it is not.
FWIW, my own view (entirely unqualified, but I have been blessed with an ability to read), is that HCQ is undoubtedly extremely effective in the case of mild to moderate Covid disease. It rapidly clears the virus and prevents symptom escalation.
Thereby vastly reducing the numbers requiring hospitalisation, and probably also reducing transmission.
It's win/win/win.
Extremely low cost, very safe at the low dosage which is used for Covid (I cannot find any confirmed cases of death from heart arrythmia) and easily manufactured and widely used in most of the world with a few notable country exceptions..
Countries in Europe and some other parts of the world that are known to use HCQ simply have the lowest death rates and for some of these the epidemic is all but over.
Spain is the obvious example. Hit hard at the beginning, but began employing HCQ and now has almost zero deaths.
Still having between 200 and 500 new cases a day, but in the last 5 days, not a single death reported.
For myself, it hasn't been conclusively proved whether Azithromycin alongside HCQ further improves outcome. It probably does, but I would still like to see more evidence. By adding in this antibiotic, you may introduce a small additional risk of arrhythmia, but it would still be an extremely small risk. If you have evidence of bacterial pathology, then there would be a clearer case for Z-pack (as I believe it is referred to in the US).
Zinc. Yep, add it in. Known to support the immune system, known to have anti-viral properties, known to be safe at recommended dosage, cheap, available everywhere.
But then people who take a daily zinc supplement probably won't even get Covid in the first place (or they will get it, not know, and clear it quickly).
(Same goes for Vit C and Vit D and Selenium).
Now if you have early mild Covid symptoms and you live somewhere where you are told to stay at home, self-isolate but not go to your doctor, you will be denied the opportunity to receive HCQ, when it is at its most valuable and most effective, and your illness may escalate, such that you need hospitalising...
And if you end up being vented, the chances are you will die (88% in NY).
Here's an MD, who makes your point:-