Member Info for RegulatorUK

"correction - we don't self test ourselves for flu.

if they test a small number of vulnerable patients in hospital it will not necessarily extrapolate to millions of sales of self test covid lft if subsequent variants become less and less severe."

You seem to keep making assertions on the basis of no understanding of what actually goes on.

'Flu testing in the UK is multi-strand. It's not just "...a small number of vulnerable patients in hospital". There's sentinel lab surveillance, community surveillance, primary care surveillance, secondary care surveillance, mortality surveillance and environmental surveillance. Each of those has a range of testing methodologies.

@Captainswag “ we dont test for flu"

This canard has been addressed several times, but I put it to rest again for the hard of comprehending...

We do test for the 'flu. We publish weekly 'flu statistics based on that testing ( https://www.gov.uk/government/statistics/national-flu-and-covid-19-surveillance-reports-2021-to-2022-season ) . Our testing feeds into an international 'flu surveillance system which helps inform 'flu strategies and with the development of vaccines.

"With £3-£7 per test, the revenue potential is between £300m - £700m p.a. I believe that Omega could easily do that. Let the orders flow."

We are unlikely to get £3 - £7 per test. Costs of LFTs have fallen significantly in recent months, with new entrants to the market (particularly in Europe). If we are supply the national health services in EU countries we will most likely get <£2 per test (the most recent figures I saw quoted the French NHS paying about €2.20 per LFT at present) - we'll slightly more if we sell into the private testing market (e.g. via DAM Health).

Even at those prices the potential is significant.

"It appears quite a few companies on the stockmarket believe they can keep tapping shareholders for liquid cash without giving good reason for their demands. I would like to remind the board of directors of this company and others, that it is us shareholders that have control.

In short private investors should hold onto their hard earned cash and watch companies go bust. The pandemic has created an economic down turn, not seen since the great depression of the 1920s. I am not using my cash to support the ever growing needs of uneconomical companies with boards of directors whom are essentially incompetent
. Odx being one of them."

Don't let the door hit ya where the good Lord split ya...

It's a Daily Wail article... so misleading.

The variant has been around for 30-40 years. This is a review of historical data. It responds just as well to treatment as the other strains of HIV.

"Am I missing something here - but my reading of the RNS is that this approval is provisional and subject to the successful submission of further data? Consequently, until that further data is submitted and approved they can't sell anything?"

Your reading is incorrect.

"this is good news

https://twitter.com/SkinCrypto/status/1489250726282858499/photo/1"

Not sure why that needed clarification. The RNS was quite clear for those with a basic understanding of CE marking.

@JafTrade:

The EMA web-site is probably as good a place as any to start, to understand CE marking from an EU perspective:
https://www.ema.europa.eu/en/human-regulatory/overview/medical-devices

Post-Brexit, there's a dual role for CE marking in the UK, alongside the new UKCA mark (which will only apply in the UK). The UK government website gives further details:
https://www.gov.uk/guidance/medical-devices-conformity-assessment-and-the-ukca-mark

"Latino - it’s conditionally approved on being able to supply further data presumably as they self certified - so if the data supplied isn’t up to scratch what then?"

No it's not. I refer you to the post I made earlier.

CE marking for self-test (HUA) is not subject to self certification under the MDR - self certification by manufacturers only applies to devices for professional POC use (other than for a small list of specific devices)

CE marking for self-test is done by the relevant competent authority. It is not unusual for approvals to be subject to conditions (which are normally data related).

"The timescale was out of ODX control but the main thing is now they have CE marking. Am I right in saying they can sell in the UK under this marking until regs change in 2023?"

No they cannot. The CTDA regulations apply on top of any CE marking (except for any exempt supplies as per the exemptions list). I thought the RNS was fairly clear on that point...

"No can this do 50-100% or will it be sell on news we shall see as the covid hype is over now, abot too late for a self test."

Not sure what you've been sniffing, given this incoherent rambling, but if you think Covid is over you're a fool.

"Suggesting that it's dead in the water unless they submit new data by 10th February which they have said is unlikely."

That's not what they say...

The TWat team will be working overtime today, trying to spin this into a negative.

It’ll also please the dust traders, who will sell into the rise for beer and pizza money.

The LTHs will sit tight, knowing much better is to come…

"@TWatcher, what does my investment history have to do with you?"

The TWat likes to think of himself as some sort of investment guru and get into willy-waving contests...

...but he often doesn't know who he's playing with. Best thing to do is just filter him.

Hysterical nonsense from a new account...

No thanks! I'm really not interested in the incoherent and inchoate rants of a bunch of PIs with little or no experience in running a company in this field.

"Boris Johnson’s government has been accused of “wasting” billions on unusable personal protective equipment (PPE) and buying kit at inflated prices, after a report revealed the huge scale of losses.

The department of health’s annual accounts report revealed that £8.7bn spent on PPE last year had been written off – admitting to a “significant loss of value to the taxpayer”.

https://www.independent.co.uk/news/uk/politics/ppe-waste-nhs-spending-report-b2005093.html

Once the sociopath in Number 10 is booted out, the next PM will need to pick up the pieces of his disastrous decisions around Covid. This will include addressing the significant issues around access to reliable testing.

Morning Benny!

*Waves*

RMS shareholders shafted themselves...