Member Info for RegulatorUK

"Hasnt Omega only guaranteed 200k test per week? So they could potentially sell the remaining 300k per week else where at a higher price (higher profit) - thus not impacting their obligations to the RTC or UK Gov"

There was an initial commitment made by the consortium - we don't really know what subsequent commitments have been made, as we are surmising primarily from the RNS' of one member of the consortium.

I wouldn't be surprised if the consortium has increased the level it has committed to providing as demands have risen. But I am also sure they will not necessarily committed all of their capacity.

"And where did Omega ship the first set of tests to ...... Senegal (RNS dated 9th June)"

Those weren't the UK-RTC test. It was the Mologic IgM, IgG, IgA Triple Antibody test.

"what would not surprise me is if this govt had initially said that the wanted from ODX 200k per week, now realise that they want a lot more and Omega are saying that they have a bunch of private companies interested.............then you have NCYT coming along with an antibody test in September.......

Anyone who has worked with public sector will know they are neither quick or logical!!"

ODX aren't selling the UK-RTC test...

...if you're going to **** off the public sector you might want to try and get the basics facts straight first.

"So many mixed messages between Johnson, Han**** and Harding. Harding seems to be saying that 500,000 tests a day by the end of October will be for lab tests and the additional figures mentioned by Johnson will be antibody tests. What additional figures? Does anyone know? Anyway glad we have 5 tests, 2 lab and 3 poc. Covered all bases."

The figures being quoted by Hattie Manc0ck and the Bloviating Blob are theoretical capacity figures across all the testing pillars. It includes antibody test capacity (which at the moment is running at about 5,000 per day using the rather second rate tests that were procured earlier in the year).

No-one knows what the exact split of the figures being quoted will be as each time Hattie Manc0ck, the Bloviating Blob or Dildo Harding are asked different answers are given.

Examining ****erel trails would probably give you more accurate information than anything one of those three said.

"Can I throw into the mix that maybe Colin /ODX are being slow because they want the agreement to run out in three weeks time and then they are free to sell to whoever has the money and not to a group who have them over a barrel regarding price?"

Can we put this canard to rest? Although the MoU may expire, it is unlikely to affect the price that the Government would pay for the UK-RTC. This was a test developed with public funds and the agreement will reflect that. It is likely to have provisions that extend beyond the term of the agreement (fairly standard in these sort of agreements).

Also, what you are suggesting would also require all the parties to the UK-RTC to agree to such a course of action, as ODX will not be selling the UK-RTC test - another member (CIGA) of the consortium is responsible for that. Plus, of course, any such agreement would potentially be viewed as unlawful under the competition rules.

In any event, if the UK-RTC tried to strong arm the Government, the Government could simply invoke the emergency powers it has already been granted and take over the companies' manufacturing capacity.

"It's was only the last share talk one regulator that was kept back so far.. all the rest have been same day."

I thought there were two that were next day? I may be wrong (trying to keep tabs on too many stocks).

In any event, they're not published straight after the interview as the lawyers need to double-check them.

The interview won't be published the same day it is recorded. They lawyers have to crawl over it first.

Hattie Manc0ck, the most incompetent and corrupt Secretary of State for Health ever, deserves everything he gets...

"That looks like the Fortress test that had 82-4% sensitivity."

I'm not sure it's the Fortress test - although it looks like an unbranded version of one. It's an IgM/IgG test so it could be a unmarked Fortress test that's been provided for the Pillar 4 surveillance testing.

I would think that the IgM/IgG test for the surveillance programmed will be replaced by the UK-RTC test once it's rolled out, the UK-RTC is more accurate.

"MB, I really hope you are right in your theory. I think the government has been slow to react to the importance of what diagnostic companies can offer.

I think there should be something set up to help and bridge the gap between the diagnostics firms and the health authorities, enabling a clearer route to market and allowing for a better engagement with the relevant body.

There just seems to be too much bureaucracy going on within the health authorities of the U.K., it appears to hinder things when instead the best cause of action Would be to act.

My biggest issue is with the MHRA and their perceived lack of urgency. Maybe something needs to be done to change things there to make decisions speedier, someone on this board might be able to shed some light there..?"

This *is not* a health authority issue.

This *is not* an MHRA issue.

This *is* a Westminster government issue.

"Just be patient , I’ve been through this many times , invest when others fear , I know it’s hard and twats like TW don’t help but if he’s slating a share it’s for personal reasons and therefore a sign to buy imo , give AZ the time to tie up the deals required and things will look a lot better , I’m down currently but have full faith in syme"

^^^^
This!

I'm actually still up (significantly) but I'm not letting a single share go.

"o anybody know whether we are achieving any sales for “professional use”?"

They're at 'pre-order' stage. They can't firm orders up/confirm orders just yet.

"Aside from the immediate covid testing opportunity, this pandemic will transform the UK diagnostics industry from a handful of small niche businesses into a large nationwide powerhouse. These covid test will pay for the next generation of tests and fuel m&a to strengthen the industry."

I sincerely hope that this is the case...

...but i fear other issues may scupper the transformation over the next few years.

"I wonder what sort of reply would be received if a similar email was sent to the Odx marketing department"

ODX won't be marketing the the UK-RTC test in the UK. CIGA are the official distributor on behalf of the consortium.

"Thanks Maylands. More great info. Thought occurs to me on the antibody/antigen debate. At the minute people are waiting 5-7 days for lab results. Antigen home test looks as if will be delayed for some time if ever it reaches required sensitivity. Meantime, if the antibodies appear at 4/5 days, why bother with an antigen test.....just wait the 4/5 days for a negative/positive antibody test. Saves huge amount of lab expense."

Because it not that straightforward.

There are different antibodies that start to appear at different times. The first to appear are IgM. These can begin to appear from Day 1 of an infection. However, they may not be measurable until much later, depending on the individual.

IgG don't appear until about Day 10 - Day 14.

So if you have any antibody test that includes IgM it might give you an early indication of an active infection - but the most reliable way, at the moment. remains molecular testing. The next best would be antigen testing, as as when that can be reliably scaled up.

He's a grifter - plain and simple. He's about as credible as a Hattie Manc0ck promise on Covid19 testing...

I've has a slew of RNS' this morning across my healthcare portfolio. There's just one missing...

"@reg - why it is not ?"
"@reg - just for you. Let me now get back to the morning routine."
"Regulatory Agency (MHRA) to provide necessary approvals for its use by the general public"

I asked the question as people often misunderstand the process for the approval of medical devices in the UK. You initially stated "King is just waiting for MHRA approval and the floodgate of orders will open. Those who are complaining about orders, understand the basics first." without identifying what it was that needed approval.

ODX isn't a one trick pony - it has a basket of tests, of which only one currently awaits NTAG/MHRA approval.

"King is just waiting for MHRA approval and the floodgate of orders will open. Those who are complaining about orders, understand the basics first.

Most likely this SP will be in the 200p+ zone in a month's time, so open your eyes and load it up as much as you can. GLA!"

What do you think needs MHRA approval?

“ Your first mistake is the unit cost to make which is £0.75 not £1.50.
So if we sell to the uk gov at £1.50 our costs are covered and we have 50% margin.”

If the cost to manufacture is £0.75 and we sell at £1.50, we have 100% margin - not 50%.