Member Info for RegulatorUK

"We can sit safe in our vaccinated havens and throw stones at those that were under fire."

I've managed to comply with procurement law for healthcare-related contract worth hundreds of millions of pounds during the pandemic... it's not actually hard to - particularly if you have the resources of the state at your command.

There is no excuse for the blatant cronyism and corruption that has been rife in the government's handling of this crisis to date - and which is continuing.

"I do not doubt as explained in detail within the judgement is correct - ... nor is there any question that HMG did not receive value for money..."

Actually the issue of value for money was not so clear cut. The defendants assert that Public First were the only agency able to offer value for money. The judge very clearly rejects that assertion, amongst others, at paragraphs 158-164.

"... but the correct procedure was not carried out to prove there was no bias although the court agrees that there was none."

No-one is required to prove that there was bias - merely that there was the potential for bias. As the judge makes clear at paragraph 167:

"It is emphasised that the court is not concerned with any suggestion of actual bias. But, as explained above, the absence of actual bias is not in itself a defence to an allegation of apparent bias."

"So basically the GLP won on the 3rd part of their claim "there was a real possibility of bias, having regard to personal connections between decision makers and the directors of Public First".
All of which should have no bearing on Abdx or ODX as grounds 1 and 2 were rejected."

It's a bit more than that. What this case has established (see paragraphs 178-181 ) is that the GLP has standing to bring judicial review in relation to matters is which it is not an economic operator. That will stand them in good stead for the other cases in the JR pipeline.

I've always said that I don't believe the Abingdon case is the strongest. I have a feeling it was chosen to give the courts the scope to make a judgement that will clarify the breadth of Article 32 discretion. That will work in the favour of the likes of Abingdon and ODX.

The BBC reporting of the judgement is very slanted (in favour of the Government). It's worth having a read of the full judgement: https://drive.google.com/file/d/1zf_3NXeMNd_c0yqF301e-oBt81ZuiA6T/view

"You may have missed this bit:

"the Board is confident that the machine should be fully operational by early July"

They were also confident it would be fully operational three months ago...

"Deadly serious the technology is amazing,"

Actually, it's not that amazing and it's competing against similar approaches from other companies who are ahead in the game (I know some people won't want to admit that but DYOR and look at what is already in use in hospitals, etc.).

"... the management are the problem and booting TB out has probably been more harmful than good."

It's not just the management that's the issue - the shareholders who led the revolt have to shoulder a lot of the blame, as does the beloved Dr Cave, who has hyped and failed to deliver.

I took a gamble on RMS, hoping that the BoD would be able to deliver something as simple as a mask in the middle of a pandemic. They've shown themselves incapable of doing so.

"NCYT antigen will need CE marking and then evaluation by Porton Down so its a way behind some of the candidates we currently have in the mix."

It's so far behind that it's almost over the event horizon...

"sure creen dont have home use approval"

SureScreen is one of the tests that has passed the PHE PD assessment for home use.

"... after the usual several months delay for technology transfer? At this stage it would be FAR better for ODX to just start churning out Visitect. Higher margin and they are already set to go."

Which is exactly what they're doing.

"Well this year we have had the jabs and seems to be working to the extent the hospitals are not getting hammered with virus patients"

Except we're now at the beginning of the third, with hospitals reporting increasing numbers of Covid patients. For example, these almost doubled in Manchester over the weekend...

The fun bit will be on Thursday morning (10 June), when Handjob will be answering questions as part of the joint inquiry of the Health and Social Care Committee and Science and Technology Committee. They won't go easy on him...

They're written questions - he'll get written answers. He won't "be questioning" Handjob...

Has seen hospitalised Covid patients almost double over the weekend.

This is not over - and testing will be a part of life for a long time.

Floreat Omega!

"Hahaha regulator, go to any hospital in the Uk, and see what I’m talking about, it’s not possible for porters, cleaners, receptionist to keep changing their masks, they come in to contact with too many people. Lol but do love the sense of humour."

You obviously haven't picked up on what my day job is...

gkb47 isn't very bright...

"I’m not telling people what to do, surely all you bashers would of done your research and known up till now we had not applied for a European CE mark. "

Not quite correct. We already have a CE mark for professional use (as per the RNS of 22 March 2021). This is an application for a CE mark for self-test use.

"But we are only now “engaging with regulatory authorities” ?
What have they been doing for the last six months ?"

I think you're missing the point...

It is already CE marked for professional use. This is engagement around CE marking for self-test - something very different, as it requires specific Competent Authority authorisation. At a guess, and reading between the lines, it's being done now on the basis that it (or the Mologic branded equivalent) is about to be given self-test authorisation by MHRA. Making the application on the basis that one Competent Authority has authorised it already makes the process much quicker.

As Colin says: "As the global market for Antigen testing develops the Company believes self-test approval will be a key product differentiator, as has already been seen in the UK."

"Hospital, Porters, cleaners, receptionist, etc are not changing their mask each time they pass some one on the corridor. These masks have huge use in hospitals, if only dr cave could employ someone competent."

Porters and cleaners are subject to the same IPC requirements as clinical staff if they are operating in clinical settings.

"As the RMS masks cost more than stanadard surgical masks, it is more cost effective for doctors, nurses and dental surgeons to use standard surgical masks, I have been told this based on any member of staff that has to change their mask frequesntly due to splatter, for example, a dental surgeon needs to replace their mask for each patient, how is this then cost effective to use an RMS mask? Thoughts?"

I've flagged this up previously. IPC requirements will militate against there being widespread use of this masked within most healthcare settings. There are other significant sectors (e.g. hospitality and transport) where this mask would be a better fit.

"Regulator - that's a quote taken from the Innova head so I imagine he must be aware of these elements?"

You would hope so... but then I look at what happened with Avacta (a UK company) and I wouldn't be so sure.

"Can someone post the link of the approved LFD tests - trying to find the link at the moment."

What to do you mean by 'approved'?