Roundtable Discussion; The Future of Mineral Sands. Watch the video here.
"there are no NHS tests........"
"NHS tests still available online"
There are national shortages of LFTs in the UK, thanks to the CTDA regulations and the incompetence of the UKHSA.
NHS providers used to provide their staff with LFTS - now those staff have to get them via the same online process as everyone else. Hospitals are being told that the LFTs they have must only be used for testing patients (and those tests are in short supply).
Whilst the online systems tell you that tests are available, particularly for collection at pharmacies, they quite often aren't. I got a collection code over the weekend - but when I got to the pharmacy they had run out three days before. They had told the central system but people were still being sent there to collect tests.
The UKHSA is screwing up big time. To date, after three months, it has only authorised 13 tests out of the hundreds that have been submitted - and of those manufacturers, only one is actually British. The rest are overseas manufacturers (albeit that some of them have UK manufacturing bases).
I would expect to see another tranche of approvals before Christmas and the next set of restrictions... but I can see legal action happening fairly soon, as some of the UK developers/manufacturers lose patience with the obfuscation, delay, incompetence and corruption surrounding the CTDA system.
"The UKCA marking came into effect on 1 January 2021. However, to allow businesses time to adjust to the new requirements, you will still be able to use the CE marking until 1 January 2023 in most cases.”
Except the CTDA regulations have superseded that.
The government has completely screwed up the medical devices regulatory process in this country.
"@RegulatorUK, a possible market of 67m people in the UK against 448m in the EU? Who needs the UK?"
I absolutely agree. Forget the UK for now - we need to concentrate on European sales, particularly if the mutterings in Germany are correct about the emergence of another new potential variant of concern.
I hold both ODX and Avacta (as well as a few others... but the less said about Nanosynth the better).
Our days will come in both shares - but we need to temper this good news with the fact that we still have to deal with the absolute shower of ****e that is the UKHSA.
"It’s not misleading. It’s factual."
It is misleading. CE marking does not enable it to be used in the UK as the RNS implies: "...the AffiDX® SARS-CoV-2 antigen lateral flow test has received a CE mark for use as a consumer self-test in the UK and EU."
Under UK law it must pass the CTDA assessment. At present, it hasn't. If it had, then you would expect the RNS to clearly state this. It doesn't.
"Wait, what? Can we sell to Joe Public in the UK now or not??"
No.* The RNS is misleading.
*Unless we have also passed the CTDA process, which the current list (https://www.gov.uk/government/publications/covid-19-test-validation-approved-products) would suggest we haven't.
For those getting excited about FDA approval, I suggest you follow Michael Mina on Twitter...
It appears the FDA is following the example of MHRA/UKHSA - bogging manufacturers down in unnecessary validation and testing processes, whilst favouring a few manufacturers. This has led to a shortage of LFTs in the US... which sounds mighty familiar.
"https://www.gov.uk/guidance/ce-marking
It should buy us time for getting UKCE though."
Not really relevant now, as the UKCA process for Covid tests has been superseded by the CTDA regulations: https://www.gov.uk/guidance/covid-19-test-approval-how-to-apply
"ODX is dealing with a ‘notified body’ i.e. an entity that acts on behalf of the EMA as a sort of intermediary."
Notified bodies don't act on behalf of the EMA - they are independent third parties that are recognised by the relevant competent authority within a jurisdiction.
Nope - this RNS is potentially misleading in suggesting that the test has approval for self-use in the UK.
"...announces that the AffiDX® SARS-CoV-2 antigen lateral flow test has received a CE mark for use as a consumer self-test in the UK and EU."
There's some heavy criticism of the FDA approvals process from Michael Mina on Twitter. It appears that the FDA are taking a similar approach to the UKHSA - bogging manufacturers down in unnecessary validation and testing processes, whilst favouring a few manufacturers. This has led to a shortage of LFTs in the US... which sounds mighty familiar.
Hmmm... the Avacta RNS appears to be somewhat misleading. It suggests it has got UK self-use approval. The CTDA approvals list would suggest otherwise.
“ They'll pass tests when they're sure no-one will sue if they're at all inaccurate.”
Except that’s nonsense. The reason they’re able to keep using the less accurate tests is because they’ve waived liability. It’s also the reason they were able to roll out the vaccine so quickly - corporate and state liabilities were waived under the Coronavirus Act.
I would urge caution about the US market. As Michael Mina has been flagging recently, the FDA has introduced new requirements for LFTs which mean that many of the existing devices (including ours) may not be acceptable. Unfortunately, the FDA seems to be taking the same daft approach as the UK government on this...
"Makes you wonder why these were brought in as they have basically shut down the U.K. industry."
It was brought in to address the cowboy travel testing companies - except it didn't actually address the problems, as the tests being used weren't the problem.
"The CE mark should have been sufficient. It is an admission the CE mark failed."
The CE mark is sufficient for professional POC - which is what (with the exception of a small number of medical devices) ot was designed for. The CE mark system hasn't failed - UK governance has.
"They should have reviewed each test and withdrew the CE mark on any test that was not up to standard. Yet they managed to introduce a fee to review what they failed to do in the first instance approve a test properly and have done it at the expense of the whole industry."
As I indicated above, the CTDA was put in place to address the failings of the retail test market - but it doesn't do that. All it does is screw over manufacturers (unless they happen to be Tory Party donors or mates of ministers, in which case they get added to the exceptions list).
Don't know who writes the Wallet Investor ****e ...
"Abingdon Health Plc stock is a not so good long-term (1-year) investment"
but 1 year is not a 'long term' investment.
That’s the testing regime recommended by NHS England/UKHSA. The same regime applies to NHS providers.
Only staff working in higher risk units will be required to test more frequently.
I see M&G have taken a position in TTG, who are potential producers of the test for BRH/Paraytec.
“ Meanwhile Prof Shaw, Exeter, has his test on GB News for a 10 min discussion.”
That will have been seen by about 100 people max… 75 of whom work for GBeebies.
“ https://www.telegraph.co.uk/world-news/2021/12/13/south-africas-omicron-covid-outbreaks-may-already-running-steam “
The Torygraph. About as reliable a source for scientific fact and consensus as Nadine Dorries.