Member Info for RegulatorUK

"knowing this gov someone whos mates running the 27 quid a test company"

I know a few people are having a very close look at the Lampore and DnaNUDGE procurements - particularly as the latter is run by colleagues of SAGE members...

DHSC has been hollowed out over recent years and is in complete disarray. They're only really able to focus on one major issue at a time - and at the moment that issue isn't testing, but the extension of the contract for additional elective and emergency capacity for the NHS. This was supposed to have been settled a couple of weeks ago but the Treasury intervened and caused delays - this has led to further issues arising. This contract extension is key to preparing for any second wave and/or winter pressures.

This means the DHSC contracts team are concentrating elsewhere at the moment...

"Regarding the UK strategy, it's always been about timing. They will deliver the mass testing program when all the pieces have been put together and when the testing program suits the phase of the pandemic. The longer they wait to mass test, the higher the immunity rate, the easier it is to share the go forward management."

One would hope that was the case but I'm afraid the UK's response is being driven by political expediency more than the science and best practice. Whilst we fail to have a proper locally led and driven 'track, trace and isolate' process in place we will struggle, with policy being made nationally 'on the hoof' to deal with whichever ministerial, familial or SPAD related breach of the guidance comes to light...

“ This is the first time it has been stated they can sell to anyone other than the U.K. govt“

No it isn’t. This was made clear in the recent investor presentation.

“I think still a bit to go yet -
'To achieve self-testing accreditation, pre-approval from the MHRA is required to perform self-test usability studies. The planned study will be performed by Ulster University using approximately 2,000 volunteers and, once complete, will allow the UK-RTC to seek final approval from the MHRA for self-test use. In addition, the test will also be subject to further independent evaluation.'’

I think you’re conflating two things. This was initially intended to be a POC test and, as such, administered by a healthcare professional. It is now approved for that purpose - and will be in huge demand.

They’re now moving on to validate it for patient self-use, which is a new development that opens up another market sector.

Not always - but I think they've graded the posts too low.

Problem is, they won't get the calibre of people they need at those pay rates.

The Indian company is a 100% owned and directly held subsidiary of the UK company.

"Still sounds like surrounded in Government beaurocracy.

Whilst beaurocracy surround this whole process, people are dying and economies are being broken.

I do think overall this governemnet has been an absolute shambles, incompetant to the extreme and have without doubt in my mind blood on their hands due to their dithering and dangerously ill conceived guidance. I specifically say ill conceived as ill advised would give them an out. I do not think it is the advice per se, that has been at fault (although I'm sure much was) but in how the government has translated that advice into actions and decisions that have cost many their lives."

Abso-bloody-lutely!

"... it seems the world is crying out for fast reliable tests which puts me somewhat at a loss as to why PHE seem to be so incompetant and recalcitrant in getting these things signed off."

It's not actually PHE that signs these off, as such. You can either CE mark the test (having amassed the relevant clinical evidence for efficacy) or, alternatively, submit it to the New Test Approvals Group (NTAG) for review and a derogation. NTAG operates through the Medicines and Healthcare products Regulatory Agency (MHRA).

Once a test has been CE marked or approved by NTAG for derogation, it can be sold on the open market. However, for government purchase/supply, it needs to go through a further Department for Health & Social Care (DHSC) approvals process, which is led by PHE. This is politically very sensitive at the moment, as DHSC/PHE have had their fingers burnt (e.g. the Roche tests) and are also having to negotiate with the Treasury and the Cabinet Office. Add into the mix the fact that parts of government have gone off the idea of 'Test, Trace and Isolate' as an approach and you can see the political minefield that has to be negotiated.

As the UK-RTC has the additional baggage of being an 'official' research process, this makes it very difficult to ignore the politics and pushing forward with simply CE marking and proceeding to market.

UK-RTC will get there. Patience is required... but that patience will be rewarded.

"Omega have already been let down by the govt, when they chose to roll out ROCHE antibody testing, after deciding that the RTC antibody test was not sensitive enough."

That's simply not the case. The government has bought antigen and antibody tests from a range of sources, including Roche, whilst the UK-RTC tests were being developed - with government support. The UK-RTC will get government contracts for their tests, once PHE/NTAG give approval. That should happen in the next couple of weeks. ODX will benefit greatly from that.

The NHS is gearing up for the second wave and worse than usual winter pressures (this is part of my day job). POC test kits (both antigen and antibody) will be in great demand, both in the UK and abroad.

But ODX also has a lot of other lines which help make it a long term hold.

As I understand it they already have manufacturing facilities at Alva, Clackmannanshire and Littleport, Cambridgeshire.

Suggested to my partner he buy some ODX shares just after the placing. He declined and suggested last week I was going to lose money.

He texted me this morning saying he'd bought 25,000 at @41.4p. What a difference a few days make, eh? What commission should I charge him for the tip? ;)

Sold off my SNG shares in April to but ODX shares...

"Health Secretary Matt Han**** is to make an "important statement" providing a coronavirus update, the Commons Speaker has told MPs.
Sir Lindsay Hoyle confirmed Mr Han**** will appear in the chamber at 5pm on Thursday.
He provided no further details about the content of the statement, although the Government is meeting on Thursday to decide whether Leicester's lockdown will continue.
Announcements in the House of Commons list the topic as 'Covid-19 testing'"

There's nothing on the Order Paper about this. I've reached out to see if anyone can confirm what any statement may be about.

"Regulator - you are just clutching at straws and making excuses for what was, by general consensus, a poorly crafted RNS. My concern, as with other AIM companies, it that it's indicative of poor management. This comes not long after the Sky TV interview that also had to be clarified. I suspect he's out of his depth now."

Not at all. I'm reading it from the perspective of someone who works in healthcare and who does business with both Westminster and the devolved administrations. And as someone whose organisation needs to test thousands of staff each week...

"So if that was the contect (and it's not clear it is then why single out just Scotland, i.e. not NI & Wales). Whichever way ypou slice and dice it it's clumsy and inaccurate."

Simple - the Scottish government is more likely to plow its own furrow and want that to be known.

"Does CK also accept that Scotland is in the UK? tell him if not we'll move production to England and slap tariffs on Scotch."

Health is a devolved function. Any agreements on the purchase of tests will be done by the relevant devolved administrations. For England, it will be done by the UK government as there is no separate English administration. Hence the referenced to "the UK" and "Scotland".

I'm rather bemused by the suggestion that the RNS is incorrectly worded. I'm actually rather pleased with this RNS, in particular:

"We are proud that we have been able to quickly focus on these products, along with our partners, to not only meet the testing needs of Scotland and the UK, but also make them available globally. "

"Perhaps most importantly to us, and hopefully to you, our shareholders, Omega has been well positioned and highly proactive in playing a key role in developing and manufacturing much needed COVID-19 tests for use throughout the world and, more specifically, to also be able to serve the needs of the people of the UK and Scotland."

This suggests to me that there may be agreements in the offing with the UK government (in relation to England as there is no English Parliament) and Scottish government (health being a devolved issue) around the UK-RTC tests. It's also explicit that these tests will be sold internationally - i.e. the UK administrations will not insist on monopolising supply.

"Surveys are starting to show that Asymptomatic carriers of Covid 19 do not transmit the disease, they are not contagious.
Your thoughts."

What surveys are these? The reliable clinical evidence is increasingly pointing the other way - that asymptomatic transmission is an increasingly significant factor.