Member Info for RegulatorUK

"Mikey-P.
Is that the best de ramp you can do?"

Mikey P isn't deramping...

He's pointing out (correctly) that the claims being made for the tests being sold by the Green Office - which *IS NOT* the UK-RTC test - are misleading.

"@Reg
When does Fortress lose its EUA?"

If I recall correctly it was last week. It's now listed on the No Longer Covered by EUA list: https://www.gov.uk/government/publications/medical-devices-given-exceptional-use-authorisations-during-the-covid-19-pandemic/list-of-medical-devices-that-are-no-longer-covered-by-an-exceptional-use-authorisation

"With the Antibody test we sit in Pillar 3 of the test & trace system, which currently gets very little attention, however this will change with any vaccine release. with a vaccine realistically you need at least 2 tests, pre and post, then you could need one every six months, that will be transformational for the UK-RTC as we have a foot in the door with the government, why would they go elsewhere. If the Mologic antigen test gets sorted and we start picking up contracts from Pillar 1&2 then the cream on top,"

We're also Pillar 4. We know that the Fortress test currently being used by Imperial/Ipsos MORI and ONS is losing its emergency authorisation and they are moving to a newer, more accurate test...

"RNS.. No RNS..
I’m able to buy 20% cheaper than before we announced the long awaited government contract a couple of weeks ago.."

Yep - I've topped up this morning, moving my average share price to 44.7p.

"But the long awaited government contract hasn't been announced yet? A £1m overall order has been put in place but this is not anywhere need the contract we are waiting on, or do you disagree?"

I think you're confusing things. There has been a government order for an initial 1 million tests - not for £1 million. There has also been a government order for £10.2 million for components to ensure future supply.

"RNS has more impact on Monday rather than a Friday..."

Not always. Friday RNS often provoke FOMO/WWTBOOTOTW... take a look at BRH this morning.

"This share is gonna blow today!!! Amazing!"

My average price is 14p so I predict that whatever happens I'm going to smiling at the close of the market...

"Funny how the doom-mongers are keen to share their concerns with us before market opens every day."

I just have a funny feeling we may get an intraday RNS today...

My apologies - it was the Pharm2Farm trials at Nottingham that's was hit by the CL-3 license issue.

"tomvisual - forget regulator uk. he's jealous. i know him from odx."

Hardly. I'm invested here and have actually suggested to people on the ODX board that they might want to take a look at BRH as well.

"Based on their ability to complete a POC in 4 months, I can’t see regulatory approval taking long."

Unfortunately, it appears the University let the license for their Level 3 labs expire. The renewal requires a site inspection visit from the regulatory bods, and the capacity for that is limited at the moment due to demand.

Hopefully this can be overcome but it may bring an unwelcome delay...

"CK boxers why don't you sell and leave??? Simple solution."

He can't sell what he hasn't got... he's just another one for the green recycling bin.

"It was posted yesterday on Twitter. It's authentic- I checked. But ok. I will get on my pc."

I think you may be confused. The AbC19 trademark application was approved recently in the US...

"Where did you see the AbC-19 US FDA assessment? can you pls post a link"

Abingdon Health as a manufacturer is FDA registered but I'm not aware that the AbC19 LFT has has FDA approval yet...

"the million ordered are for NHS staff - it was mentioned a while back and confirmed on a video call this week to the NHS staff that they would be getting these tests..............."

As you say, the initial 1 million order is for Pillar 1 testing use (for NHS and care staff).

Once MHRA self-test use approval is given, then we can expect the REACT programme (which is Pillar 4) to move over to it.

"Can anyone tell me if the Fortress kits were home use too? I think they were but i just want to confirm.

Secondly if they managed to get onto the EUA register, why are we not on?"

Yes - the Fortress kits are/were home use. They were given emergency authorisation - that has now finished.

"how do we know that's our kit?"

Because DHSC/Imperial have said they are moving to the "new, more accurate" antibody test. There's only one of those that is in the pipeline to be approved for self-test use.

"Hmmm, as suspiciously sounds like Covid has a 100% mortality rate."

No - it means that the virus doesn't just attack those with weakened immune systems. It attacks even the most robust systems and can overcome them. Basically, if you end up being hospitalised then your immune system has been overwhelmed and needs help.

Some previously healthy people are being hit hard by Covid, suffering severe effects ('Long Covid' appears to be particularly prevalent amongst previously healthy people), or even dying. This is not something that only incapacitates or kills those with previously compromised systems.

Anyone who assumes they're some sort of super specimen who can shrug of a Covid infection if the get one is a fool. They may - or they may not... it's not a gamble most sensible people who understand the implications of Covid would take.

"This is endemic, not pandemic. And I will not be taking a vaccine for what is arguably less than 1% fatal pathogen ta. I've got a functional immune system after all..."

I don't think you understand what the terms 'endemic' and 'pandemic' mean. I also think you don't understand what the mortality rate is for Covid when compared to other common viruses, and that it is irrelevant how good you think your immune system is... the evidence is that this virus overwhelms even the most robust immune systems.

That's a different part of the testing Pillars (which have gone from five to four now). The testing you're referring to is Pillar 3. The REACT studies referred to earlier are Pillar 4 surveillance tests.

"It is a trial and test of the product."

No, it's not. It's an expansion of the extant REACT surveillance programme run by Imperial College.

"Okay I stand corrected after googling this. But its been going on since June. So it cant be the consortium test can it?"

What bit of this did you miss?

"...for an extended REACT antibody surveillance programme. The tests kits aren't being sent out at the moment - this is just the recruitment stage."

They are recruiting *additional* volunteers. They have not yet sent out the test.

At present they are using the Fortress antibody test, which is less accurate than the ODX one. It is clear from the order given to the UK-RTC consortium that once NHRA approval for self-use is granted, the REACT programme will move to the more accurate test. This would be consistent with the recent withdrawal of the emergency approval for the Fortress test.

"Then take a photo and post up to a filesharing service and share. Redact your address details and any personal details obviously. It will be taken down but this board is plenty busy enough for somebody to see and verify your claim.

There are letters going out for antigen testing. Have you got it confused with that?"

Stop digging - you're wrong! This is the testing programme that is being expended: https://www.imperial.ac.uk/news/201893/largest-study-home-coronavirus-antibody-testing/ and it's *antibody* testing.

Or are you going to tell Imperial College, who are running the programme, that they're wrong as well?