Member Info for RegulatorUK

It was the 10%ers overreacting to the Pfizer news and selling up to try and get on the Pfizer train...

The reality is that it will take a significant amount of time for any vaccine to be rolled out in sufficient quantity to have a significant impact on getting life 'back to normal' - and that's assuming that the vaccine actually lasts for a decent period of time (still under study). In the meantime, there'll still be a significant need for ongoing testing.

I took the chance to top up. I suspect the 10%ers may regret their rash decisions to sell...

"Regulator, I’ve always it quite a straight forward barcode scanned update. You can see the barcode on one of the photo. See link"

You have to have something to scan it with and something to record it with... but the English Test & Trace app currently doesn't have that facility.

"Hopefully all MHRA clearance done and dusted before the Brexit transition period comes to an end on 31 December 2020."

Indeed. Whilst EU CE certifications will be accepted in the UK until June 2023, EU recognition of UK CE marking will end on 31 December 2020, and it will be far harder for UK manufacturers to export to the EU - particularly as the government has chosen deliberately not to transpose the new EU MDR and EU IVDR regulations into UK domestic law.

"One piece of the jigsaw that i do not understand ( there are other pieces) is if a self administered self test was rolled out for use at home, or anywhere for that matter......(regardless of whether it was a antigen or antibody test).....how would the government trace this information, record it, and use it to be able to use sanctions on people who ignore the results.

What would the communication between the administered self test and the government monitoring trace and test centre look like....it may be so, that you would not be allowed to use it on yourself, but only at certain points in town where the information form the test would be exported to the main government data base. If that's the case then the administering the test safely on ones self, becomes obsolete and it comes down to accuracy and speed - which makes it on par with other swab tests on the market at the moment ."

As I've been saying, it's unlikely that a self-test antigen test will be approved for full home use - other than the swab/blood sample being self administered and returned to a lab. We are unlikely, in the short to medium term, to see antigen being truly 'self-test' in the same way that antibody could be. This is because antigen tests are used for active infection and Covid19 is a notifiable disease.

Antibody testing is likely to be restricted in the short term - partly because the government still haven't go their ar$es in gear and sorted out T&T, but - if they get the app properly sorted - there is scope for that to go fully self-test in the medium to long term.

"It has mutated many times, but only recently has there been evidence of mutations (scotland and the danish mink one) that are not killed by the existing antibodies. This implies that current antibody testing would not pick that strain up.

My understanding is that it doesn't impact antigen testing."

There were (at the last count I heard) 17 mutations of the virus circulating in the UK alone.

If the mutations are significant enough - as is being suggested in the Danish case - then there are potential implications for antibody and antigen testing (as potentially different antibody and antigen markers would need to be tested for). However, molecular testing should not be affected.

"It would be interesting to understand why ODX didnt go full force with antigen testing first rather than focusing on antibody testing? Surely higher revenues with antigen tests?"

The UK-RTC was established to develop antibody testing. There wasn't the emphasis on antigen testing, as molecular testing was the key diagnostic. That was shortsighted, I think , on the part of the government... but that seems to be their trademark.

"May as well ignore all Antigen tests tenders for the time being until we have a test to sell.
Regulator. How long does it normally take from applying for a CE mark to it being granted, approx.?."

You don't apply for a CE mark. It's something that the manufacturer applies when they are satisfied* that the medical device meets the requirements in the Directives.

*This may include validation by a nominated body, depending on what the device is and which Annex it falls under.

If you remember, I flagged the issues of mutations a few weeks ago ...

...and was shouted down by some as a deramper. What they failed to recognise is that, from a purely avaricious perspective, this works in the favour of companies developing and producing tests.

"So are you in ODX Regulator and if so do you think we have a decent enough test? Cheers"

Yes, I'm in ODX (as my posting history shows).

We have an excellent Covid 19 antibody test (as a part of the UK_RTC and in our own right), amongst lots of other goodies. What we don't have at the moment is an antigen test.

What we do have at the moment is an excellent long-term relationship with an organisation (Mologic) that is developing a rapid antigen LFT. But...

...that LFT has yet to be finalised, validated and CE marked. We know that process is underway but it's never a good idea to count your chickens before they hatch.

There's no need to ramp ODX. It's a solid share for long term holders that will deliver for years to come.

"Now that's out the way the markets should be in better shape today. Everything in my portfolio is green bar one."

I've got two that are currently red (but still up overall) - Avacta and RMS. I expect RMS to rise a bit later today.

"£912m for a 3.5 month contract.. thats some going.. hopefully Colin is already on the phone."

For what? We don't currently have an antigen test to offer.

What the length of this tender/contracts does indicate is that:

(a) this is a stop gap provision contract
(b) the government is looking for better tests...

Balancing trade... common enough.

“ Jester- I think it may be nearer to end of week as delivery contract officially closes on Tuesday, get it all together and possibly Wed,Thurs,Fri. If past performance is anything to go by we will have an investor meet to find out odx are already fulfilling it, no affect on sp and an Rns July 2022.”

I think it’s worth noting there are two sets of fulfilment ITT details published. It’s the same contract but with different timeframes. I think it was republished as the first ITT didn’t give the correct dates. The second ITT suggest that bidding will close 23 November, which is more in line with what you’d expect.

Oh yes...

"And on top of that RegulatorUK you won a handy top up to your ODX fund this morning!

Way to go!"

Some ODX, some other Covid stocks...

...and a couple of bottles of Chateau Musar. *thumbs up*

"Thank you Regulator. That's pretty crucial info as some will assume from the tender wording that it's associated with self-analysis."

I always tend to double-check as I know how crap DHSC's ITTS can be...

"Regulator, where in this tender does it say or imply collection from the home?
It’s all about receipt and handling of stock, delivery and handling queries."

Its not in the tender notice. It's in section 3.1 and 3.2 of Appendix 3 (the Service Description) of the full tender documents, which says:

"3.1 The Home Testing Channel has been in operation since 06 April 2020. The purpose of the Channel is to provide UK and NI access to self-administered Covid-19 test-kits. The Channel provides an ordering portal for individuals or households of up to 4 people to order test-kits to be delivered the next day to their home address.

3.2 For information only (as it does not form part of this work package), after the test-kit has been used and a sample taken, it is returned to one of a number of laboratories, by priority post or courier. Results are issued to the individual by SMS or email. "

This is Pillar 1 molecular/antigen testing for those who believe they have an active Covid infection.

"On September 28, WHO announced its partnership to procure 120M LFD, mainly for low and middle-income countries and President Trump announced the distribution of 150M LFDs in the US.

LFD = lateral flow device... massive... although not our name on this one.."

But if the Mologic antigen test proves itself more reliable than the Abbot test (which is more than possible) then the government can switch.

"Great find LeFlic17 and inspired find Merchant Banker. So now we know:
1. About 50 million tests intended for home delivery over the next year- in the light of this single contract
2. Mologic's tests are being verified by Liverpool School of Tropical Medicine (corroborated also by the Liverpool Echo and by LSTM) with collaboration from Pfizer.
Looking very good indeed for ODX investors!"

And don't forget that the OptiGene LAMP test has proven to be useless when used at scale (as did the iAbra Virolens) so teh Mologic antigen is really the only close runner at the moment.... *thumbs up*

"Does anyone take it upon themselves to report these to any press agency that might be interested in looking into these, one might have though the labour party would want nothing more than to embroil the conservatives in a financial conspiracy of corruption?"

The press are already covering it (e.g. the Guardian, the FT and the Independent). The Good Law Project and other civil society organisations are taking legal action against the government.