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Hanvey did cover most points and very skilful ability to deliver-well versed but Michael Ellis the Paymaster General did a lot of regurgitating and when giving way I wish Hanvey had tacled him on PD and spike versus nucleocapsid and PD barriers. Hanvey did touch on this without talking science and mentioned Avacta by name and the new technology but should have expanded on the tests being highly effective because they do not target the nucleocapsid but the spike protein and that really has been the crux of the issue for Avacta.
The question is 'when will MPs start to appreciate not all scientists are right and the best test is being hindered. Frozen/excessive cold and heat applied to the spike protein favours the nucleocapsid therefore the best test cannot be approved. Does your MP want the best test or not. This is the battlefront.
Not the same as for sale in Boots though. HUA is a prerequisite and one element for approval. The desktop/CTDA still needs to be processed and in the EU believe the Health and Security Committee are the arbitrers and Meduflow does not appear there yet https://ec.europa.eu/health/sites/default/files/preparedness_response/docs/covid-19_rat_common-list_en.pdf :
"While the reverse transcription real-time polymerase chain reaction (RT-PCR) assay, which is
a nucleic acid amplification test (NAAT), remains the ‘gold standard’ for COVID-19
diagnosis, rapid antigen tests, which detect the presence of viral proteins (antigens), are
increasingly being used by Member States as a way of further strengthening countries’ overall
testing capacity, particularly in case of limited NAAT capacities or where prolonged testing
turnaround times results in no clinical utility.
The Health Security Committee (HSC) agreed on 17 September 2020 on Recommendations
for a common EU testing approach for COVID-191
, setting out various actions for
consideration by countries when updating or adapting their testing strategies. The
Recommendations included Member States’ first experiences with rapid antigen tests and
their deliberations concerning the settings and situations in which these tests should be used.
Since then, the HSC has been discussing the use and application of rapid antigen tests in great
depth, and has brought together a wealth of (technical) information on the types of tests used
in European countries and the conditions applied.
On 21 January 2021, Member States unanimously agreed on a Council Recommendation
setting a common framework for the use of rapid antigen tests and the mutual recognition of
COVID-19 test results across the EU
. The Council Recommendation called on Member
States to agree on three concrete deliverables:
1. A common list of COVID-19 rapid antigen tests "
I think the EU do apply real life samples to the process so expect approval and retail there first until UK change from bad science.
Original appointment
https://www.lse.co.uk/rns/AVCT/avacta-establishes-us-business-development-team-n2ghc21gumkc1ua.html
He has always been US based and maybe with the therapeutic groundwork in place the future is brighter for him growing that base.
https://www.globenewswire.com/news-release/2022/01/04/2360838/0/en/POINT-Biopharma-Adds-Senior-BD-Expertise-with-Appointment-of-Dr-Matthew-Vincent-as-SVP-Business-Development.html
Have sent my local MP, Sir John Hayes MP, an email and links to the debate, Kary Mullis and AVCT plus short exposition of procedural headwinds encountered by AffiDX. I would like the debate to get away from politics and down to scientific challenge.
Don't finalize until rns check at 7am
Would have thought pigspit would be in there! I would keep the pressure where it is owed. ' can the panel explain why a perfectly good LFT developed in Yorkshire, proven in use, had to have the sensitivity and specificity evaluated and pass muster in Spain by the Carlos III hospital in Madrid when an early British approval might have saved many lives last year.' (Clarify Q if required that a spike protein LFT has been held up in PD and in the desktop review.) Mention pigspit and spiked frozen samples used by regulators instead of naturally occurring viral loads and heating in the PCR process being adverse to spike protein identification since first submitted around April 2020 in any rejoinder.
If we all bought quality we wouldn't be so 'fat' - quality not quantity, likewise a good LFT would have been effective and maybe those millions of tests bought would not have been required and lockdown avoided as the effective LFT use gets adopted as policy
If you do not know who is responsible as a reader of this board, though I agree about accountability so ticked up, there will not be much hope of finding anyone who is accountable. Monkshood put forward the notion that heating the virion -for a PCR test I presume- would also destroy the spike capability for infectiousness thus destroying the affimer binding area. It should be obvious from the squirming emerging from Oxford scientists that they realise who is heading into the excrement.
Pity I can't make out what he says when he makes the salient points-suggest you do a transcript of these for Hanvey aswell as me, cheers. I believe the powers that be have lost sight of human advancement and are more concerned with self protection of £ and reputation but by acting like children the British inventiveness we all depend on is not in play.
That is what the Christmas Lecture with Van-Tam was suggesting but affimers are more biotech than gene tech which has many more dangers to it I would suggest. Very disappointed at that Christmas Lecture series when affim ers/LFTs did not get a mention and PCR named as gold standard so filling young minds with bias against affimers.
Ideally Meduflow has made the Common List https://ec.europa.eu/health/sites/default/files/preparedness_response/docs/covid-19_rat_common-list_en.pdf and the the CTDA will have an alternative route for approval and AVCT can issue an RNS on Tuesday. Any activity over the holiday could be a giveaway clue. Assuming this sort of scenario could happen because Robbo has a neighbour who knows Medusa players so big thanks to both of them. Politically it needs to happen anyway.
A more transparent system would expose the favouritism and regulatory drag/fasttrack; the UK has to grow the industry post brexit and and move out from exploitation by global business. US companies have been more visible to me and wonder how the drug retail negotiations are panning out as access for US drugs will make another hurdle for AVCT. Not a moan and hoping covid has got AffiDX through CTDA and EU conformity. A 4/1 miss though can be tolerated if hunkymonkey's comments are taken on board and AVA 6000 good news is in the wings.
Can only think it is lingering nonsense 'nda' operating by the government but not the industry as the government are talking about increasing supply and yet have no commercial transparency which is how they have mucked things up from the start. They were party to RTC and transparency could have pressured PD to alter their procedures and right now could inform the public about LFT supply and regulatory matters for legitimate examination of decisions. Ridiculous that we can still only hope it is us.
The Government trying to curry favour with China will never work. They are great fans of the British because, I suspect, we are a law abiding populace who have benefited from a past that thrived due to Clive of India style colonialism which is what China are pursuing around the world. Selling tests to us and weakening the balance of payments strengthens any trade relations in favour of China as does any IP acquisition through university research and business collaboration.
I am sure AS is keeping AVCT out of any government mandate that could result in a one-sided loss of business in favour of a global roll out of affimers in stable jurisdictions. He is just about there with a product and as Ndn hopes, the EU or any other place will be good for building the business.
Congrats to OP for spelling out what CTDA actually stands for which helps to understand the arbitrary set-up; it is just an autocratic process.
Coronavirus Test Device Approvals sought via 1/9 submission in UK but AS I would suggest is wanting the EU consumer selftest mark https://www.lse.co.uk/rns/AVCT/affidx-receives-ce-mark-for-consumer-self-testing-hx3ppgzph6wcle3.html and professional use https://www.lse.co.uk/rns/AVCT/registration-of-affidx-lateral-flow-test-in-eu-tocc4dyky87jt5q.html route to market to materialise first and a roll out globally, including the UK as a result. The UK made brand may still be a selling point but the regulatory process of the UK has some sorting out to do post Innova/ Chinese support.
Hoping it will appear on here https://ec.europa.eu/health/sites/default/files/preparedness_response/docs/covid-19_rat_common-list_en.pdf for the EU and expect an update 4/1 at the earliest.
https://www.medrxiv.org/content/10.1101/2021.12.22.21268246v1.article-metrics
I am still excited that the anterior nasal tast can be adopted in Asia, US and Europe before PD cotton on and the Government might bypass them for a 4/1 launch of AffiDX if reading this board is anything to go by. I am looking forward to a great return on my AVCT investment this year and wish AS and the team deserved success for the future.