Member Info for RegulatorUK

"They should be rolling out a massive testing program so identify who needs to isolate over xmas and who can carry on with xmas with some degree of confidence, without this is will be a free for all and infections will sky rocket. The vaccine is months away."

We're talking about the incompetent and corrupt Tory government that can't even follow its own advice on masks, social distancing etc. Do we really expect them to be competent enough to manage something like that?

And even if a vaccine were a 'silver bullet' it is going to take a significant amount of time to roll it out globally - we're talking years, rather than months or weeks - and during that time testing will remain a significant piece of the armoury in tackling and managing Covid.

"Surely if a vaccine isnt 100% all the time to all people - an Antibody test after vaccination is essential. Or are we saying - have a jab and youll probably be protected (but maybe not) Russian Roulette.
And surely ongoing qtly or 6 monthly tests to find lifespan of a vaccine and its protection is also essential (again this is likely to differ between different vaccines and different people)"

No vaccine is 100% effective for 100% of people. With most vaccines, the aim is to get sufficient herd immunity to minimise transmission and/or reduce the potential effects.

We do not routinely undertake confirmatory testing for many vaccines. Where we do, the testing regime (timing, frequency, for which groups, etc.) tends to be tailored to the specific vaccine and will be based on the outcomes from the clinical trials - in particular the Phase III trials. Therefore, you can't be certain what any regime will be until the clinical trials are complete.

Early indications are that confirmatory testing will be used for Covid vaccines - but we won't know the exact regime until the clinical trials are complete. It wouldn't surprise me if there were different regimes for different target groups even within the same vaccine (e.g. older people might be tested more).

With regards to the frequency of any vaccine roll-out related testing, I go back to what I posted yesterday:

"I know lots of people are assuming all sorts of things about pre- and post-vaccination testing (sometimes based on little more than wishful thinking or misunderstanding media reports) but - and I think we have to be absolutely clear about this - until the clinical trials for any particular vaccine are finished we are unlikely to know exactly what testing protocols will apply to that particular vaccine.

So although there is a clear indication, for example, that the AbC19 test is optimised in relation to the Oxford/AZ vaccine until those trials are complete I don't believe we will know exactly what any supporting testing protocol will be - and it may vary for different groups."

"But you'd expect candidates to agree in advance that they won't have any independent testing done outside of the trial, unless medically necessary."

Nutty, Trump-supporting Republican Senator who doesn't follow the rules.... 'nuff said. ;-)

"Candidates getting knowledge of whether they have antibodies whilst the trial is still "blinded" is a bit naughty. The whole point is that no one is supposed to know who is who, until the data is analysed."

You are right. My other half (on the Oxford/AZ trial) doesn't get told whether he has antibodies or not.

Looking at the link, I'm wondering whether he's had an antibody test outside the trial programme. There is regular testing available to members of the US Congress.

I'd have to dig out the participant guidance for the Oxford/AZ trials (which I think are buried in the mess on his desk in the study) but I believe very clear guidance is given about not testing outside the trail process and what to do if you suspect a potential Covid infection.

Many Covid-related stocks down this morning - I think in part on unrealistic expectations around vaccines being promulgated by parts of the media.

Keep the faith folks!

"Regulator, you obviously can't read nor comprehend. What people are posting. Taking things literal rather than reading between the lines. Just an average Joe."

I thought you'd filtered me? Instead you appear to be becoming a bit of a saddo stalker...

"Regulator- morning, no slant from me, I gave my main investment by far in here and I’m more than looking forward to a re rate when it comes, and it will come you bet.
But not on the news today, it’s just not specific enough, although a good inside preview of maybe where we are going to end up.
Until then status quo remains in place I predict."

Morning! I was being somewhat tongue in cheek and gently extracting the urine out of those who suggest that any note of caution is some existential threat to the existence of ODX... and means that you're 'deramping' and 'sold out'.

I'd agree with your assessment as to today's news. Some interesting stuff on the Phase II outcomes but the real meat will come when the detailed Phase III information is published - and that will happen when Oxford/AZ are ready and confident...

Sorry - meant to quote Symbo1...

:-)

"Producing good antibodys wonder how they know ?"

Ooh - you deramper you... you've obviously got 'continual slants' and 'motives'. You've clearly sold out...

Have I missed anything?

;-)

"Producing good antibodys wonder how they know ?"

They test. My other half is part of the trial (he's a front-line clinician).

He got the jab in May (he was part of the Phase I/II trial stage). He's then had weekly tests (with more extensive monthly tests) measuring a range of things, such as whether a response has been invoked (assuming he had the actual vaccine instead of the placebo), the level of response and - of particular importance - how long it is lasting.

This testing is ongoing and will be for the foreseeable future.

"My only worry is the potential sp drift if the ax/oxf gets any negative press numbers wise it seems to be Uk govt favourite and you can bet your life the usual suspects bmj deeks and Co be looking for chinks in its armour . The test is still imho gold standard and will sell like hot cakes in whatever setting it’s available in dyor gla"

I wouldn't be overly worried about Deeks and co. in relation to the Oxford/AZ vaccine. Oxford/AZ are not going to be hurried into publishing stuff prematurely and putting their work (and their reputations) at risk.

The Lancet article relates primarily to the detail of the Phase II outcomes, with a bit of high level Phase III. Deeks would find it hard to pick that apart - and he'd also be up against people who, frankly, have far more credibility and clout than he does.

The real risk is that third parties over-hype the Oxford/AZ news. The government are desperate for another 'dead cat' item to detract attention from their failures around T&T, the corruption and the failures in the Brexit negotiations. I wouldn't be surprised to see Boris making a statement full of hot air waffle and Churchillian references. Take it with the large pinch of salt you can find...

I am not worried at all. I am confident ODX will deliver for long term holders (DYOR obvs) but I'm not expecting significant and sustained changes in the share price until the New Year.

"Regulator dont be pedantic!

1/ yes he does for ODX
2/ It is our tests too.

You're continual slants are obvious. You're not the oracle of the BB and neither am I. So I take everything you say as having a motive."

They're not 'our' tests - that's just it. With respect to the AbC19 test, we're manufacturing capacity - albeit with a good deal. None of those tests will be produced with ODX branding...

And it you'd been keeping up with the news, you'd have spotted that the UK-RTC have already published what you were calling for - and ODX had already had an RNS about it.

Not sure what you mean by 'continual slants'... it's not exactly common parlance.

As for my motives.... I've been clear about those. I'm a long term holder who is trying to bring a bit of balance to a debate that is often driven by those who prone to 'over enthusiasm' - and who, when the share price then doesn't rise to meet their expectations, end up ****ging off the ODX board instead of acknowledging that the issue lies with their own behaviour.

Frankly, you can think what you like. I'll continue to engage with people who ask questions, to point out when people are talking bullsh*t (so that new investors aren't put off or ripped off) and to watch the great efforts of CK and team pay off.

" CK needs to issue a RNA setting out how ODX tests compliment the vaccine and expected demand and updates plans to upscale to meet demand. "

1). No he doesn't (and it's not the ODX test but the UK-RTC test); and,
2). That's already happened.

I wouldn't get overly hyped up about what may be said about the Oxford/AZ vaccine.

I think they're likely to release more detailed data about the Phase II results but keep the Phase III data relatively high level. They're not going to be hurried into making wildly optimistic predictions just because other firms have published preliminary/interim data.

"Weekly antibody tests?"

Yep. But you don't get the results.

The testing is to determine if the vaccine (if you've had that rather than the placebo) has invoked an immune response, at what level and how long they're lasting.

He had the vaccine (or it may be the placebo - you don’t know as this is a double blind trial) in May. He’s had weekly tests since then.

"bidstats.uk/tenders/2020/W47/739180587 - 25th Nov is the new deadline for over £900m.
Wonder whether Rapid Test Consortium (UK-RTC) might join up with Mologic antigen LFT to put a proposal together."

The deadline hasn't actually been extended. This version of the ITT summary has been amended to reflect the revised ITT summary that was issued at roughly the same (I think on 11 November).

Basically, whoever at DHSC is managing the procurement process is correcting their errors. It just shows they have clowns managing their procurements, as this stuff really isn't difficult to get right first time - the process is very straightforward.

If we're going to go down the line of sending an email to Walbrook, it might help if we ensure the statements contained in it are factually correct. Some of the suggestions so far aren't.

I quite like the idea of pushing the quotes that Vascular referred to. They're professional and factual.