Member Info for RegulatorUK

"Do You think Colin might be looking for sale so is making a right mess of it all just to make the company a better price? he doesn't have any skin in the game after all..."

Looks as though FourFiguresBu115h1t has a competitor for 'Stupidest Attack on Colin'...

“ Vaccines stop people going into hospital and if nobody is dying it doesn't matter who has it‘

Not entirely. Many of those currently hospitalised have been vaccinated. Vaccines also do not stop people dying. They just reduce the numbers who do.

" The NHS decided to give it EUA when they felt the demand was greater than what could be UK supplied - they will answer for that decision in time. "

The NHS didn't make any decision in relation to the Innova test.

The MHRA gave it EUA at the request of the DHSC. The MHRA is an executive agency sponsored by the DHSC.

Test & Trace are using the test at the behest of DHSC. Test & Trace is not the NHS.

Oh Lordy... I've never read so much bo110ck5 in one place.

Don't forget that the Grauniad likes to give The Odious Deeks a platform...

"Agree. It was bad enough that they were throwing billions at Chinese made tests in the first place surely after what has just happened even this government must choose to fly the flag now."

Yebbut.... it's *this* government... logic, ethics, and common sense don't apply.

"...as the population will put too much faith in vaccines..."

It's not just the population. Ministers use the vaccination process as their 'get our of jail free' card whenever they're asked a probing question, face an allegation of corruption or are found guilty of breaking the law.

"So it's the isolating aspect of it that is letting it down. The other data in the recent rows actually look pretty good. Thanks for the share."

It's the testing aspect overall as well.

And, to be honest, the tracing is not good by international comparison.

Really interesting little article from the Nuffield Trust on the first year of Test & Trace.

https://www.nuffieldtrust.org.uk/resource/chart-of-the-week-the-performance-of-nhs-test-trace-in-its-first-year

"Just remember approval and sales are different thing. 99% of the time member states will want to do their own clinical evaluations before buying if the EU even have an appetite to buy from the UK at all right now."

Ooh, careful.... you'll upset the Avactolytes.

"No Regulator. The degradation issue is established. Thermo Fisher identified the problem with degradation of blood samples from the process of freezing and unfreezing several years ago. They recommended that the process should not be undertaken more than twice. Professor Tara Moore from Ulster University also raised the matter in relation to the discrepancy between Ulster's evaluation and the PHE assessment of the ABC19 test. And Public Health England also changed their mind on whether to use fresh or frozen blood samples in recent months. They also acknowledged mistakes in their treatment of blood samples in the EDSAB report published in November 2020. I shared the Thermo Fishcher report and the EDSAB report when it was published."

We should just point out the EDSAB process relates to antibody testing - not antigen testing...

"Could you provide links to the independent Avacta clinical validation studies, obviously seen the RNS (which was light on detail) but would be useful to see who carried them out, how they were carried out and how many people involved."

As far as I am aware, the details haven't been published (or if they have, it's by way of the equivalent of a Vogon planning process). I know tecbadger was interested in the details, as the numbers quoted seemed small.

"Its my impression that mologics standalone test is further down that track than Avacta but I stand corrected"

Mologic's test is in the PHE Porton Down assessment process. As far as I am aware, the CE marked Avacta test has not been submitted to the process yet.

"... but Deeks has a platform, my suggestion was that he would be a useful advocate of UK produced LFT’s as he has been such a vocal critic of Innova up to this point."

Deeks will not advocate for UK produced LFTs. He does not believe that they're a reliable method of testing, which is why he has consistently misrepresented the data. He only claimed his comment related solely to the Innova tests after he faced threats of legal action.

He is not a credible advocate for LFTs. He will (ab)use the FDA ruling to undermine confidence in all LFTs.

"Because if the FDA recalls a test the UK is handing out millions of, and it turns out they're right, then that implies we're wrong."

"Regulator, no-one seriously knows exactly how it will pan out. It's more a question of us as shareholders being privy to some dynamite news that will hit the papers. I think there are some serious questions about Innova's approval. Their first evaluation results were about 84% sensitivity. And then suddenly they achieved the MHRA bar, which was 98%. If they have sent in dodgy data to the FDA they will have totally lost credibility. But yeah. It raises the question how did they get past our independent evaluation which require firms to submit at least 1000 samples for double checking.
I have an instinct it could be back to the pickle that PHE have had about degradation of frozen blood samples from repeated unfreezing and freezing.
ODX have done multiple assessments which have been independently evaluated by FIND, the US NiH programme, Ulster University and Liverpool School of Tropical Medicine. They are in a super strong position. PHE are on the back foot however."

Let's be clear - there isn't a single Innova test. There a number of tests Innova provide. As far as I can seen, the FDA press release doesn't specify which of the Innova tests they have queries on (and they may be deliberate, so that all versions of the test are withdrawn).

What we do know is that two versions of the Innova test have been independently assessed by PHE Porton Down. If we think there a flaw in the PHE Porton Down testing regime then that would impact *all* the LFTs that have been/are being assessed - including ours.

We've also got to remember that supposed 'degradation' issue was only really raised by one company - when their initial test failed the process...

I'm going to sound a note of caution around the FDA action and what it might mean for ODX (and associates).

Firstly one has to remember that, due the litigious nature of commerce and healthcare in the USA, the FDA is often far quicker to require withdrawal of devices from market than other competent authorities.

Secondly, we also have to remember that two of the Innova tests (there's more than one) have been independently assessed by PHE Porton Down. If we call into question their assessment of the Innova tests, that also would call into question their assessment of all LFTs - including ours/Mologics.

Thirdly, the likes of Deeks and the other Covidiots will use this as a stick to beat and undermine *all* LFTs, as they have an irrational dislike of them as a testing tool per se. It's already beginning to happen on social media.

Fourthly, this has the potential to impact on the government decision-making process. One might hope that they'd be sensible and scale up the roll out of sovereign tests - but then you have to take into account the final decision will rest with Johnson and Hand****, who have repeatedly demonstrated that they are incapable of taking a decision in the public interest.

I sincerely hope that this works in the favour of ODX in the long term... but I think the next few weeks may be something of a bumpy ride. There are a lot of idiots, charlatans and people with axes to grind out there who will use this FDA recall to push their agendas.

"The £561m contract should be notified within 10 days I believe....4th June on Bidstats so Monday? Either way its coming.

Regulator is more in tune with the rules that gov't (bidstats) tenders need to be confirmed by....."

The requirement is within 20 days of the end of any applicable standstill period or, where there is no standstill period, within 20 days of the Contract award.

The 'days' are calendar days - not working days.

"All of my watchlist is red apart from ODX. Glad I sold my AVCT at 254 a few weeks ago just unhappy it was when ODX was 80p and I bought £5k but don't really care that much as this has places to go and I am here for the longer term."

Can I suggest taking a look at NFX if you have some spare change? I have a good feeling about that one.... DYOR obvs.

"...I agree this is a sustained rise and there has been 2 price monitoring extensions to reduce the speed of increase..."

Eh? That's not what Price Monitoring Extensions are about...

"70p paid. Happy Thursday!"

I was kind of hoping we'd languish for another day. I'm waiting for for a chunk of funds to clear into my trading account but that won't happen until tomorrow.... :-(

I'd like it to hang on until tomorrow, when further funds will be cleared into my dealing account...