The latest Investing Matters Podcast episode featuring Jeremy Skillington, CEO of Poolbeg Pharma has just been released. Listen here.
It boils down to not having the AVCT LFT approved which was the fault of PD, if that had been sorted somehow as a test with early detection and good sensitivity all ensuing narrative would be around the building up of home diagnostics for priority. BIVDA cannot therefore report a diagnostic industry in Britain built to support this test. Nothing else is relevant to us as only approval enables best endeavours by AS. Affimers remain unproved in the UK despite the best test being derived from them. The AffiDX test works, the regulatory validation procedures in the UK fail.
You can still get posts on here of course so actually I apologize,they have not been removed. If I put 100 posts per page and set to =700 in the browser I go back 70,000 posts and one year. So I was bonkers.
I don't dwell on the past either but do want to resolve approval of spike protein tests in the UK and see understanding of that hindrance as diffusing all rants and spotlighting Sir John Bell and a means to having Sir Alastair Smith.
PL, I don't think you give enough weight to the crux of the matter- PD validation/lack of. It is the root of the whole failure of moonshot on which Cummings and BJ laid their plans when a good test could have been effective getting the R rate down. Han**** jumped in with Innova as an inadequate failed substitute for AffiDX. AS adjusted the expectation/response when he realized he was never going to pass validation in the UK without a major can of worms for the government and regulators. This board has been full of good advice and research that those in authority could have utilised and London SE taking down postings just as the mainstream press engage with the failings shows to me the mandarins at the DHSC or someone has had them all removed. They would have stood there as an indictment.
This removal of posts could constitute an abuse of process with London SE acting on info which only they are privvy to and which could be traded. Any post removed should be removed by the objector in transparent fashion when we are all legally open to prosecution, not by the LSE. London SE disclaimer "While London South East do their best to maintain the high quality of the information displayed on this site, we cannot be held responsible for any loss due to incorrect information found here. All information is provided free of charge, 'as-is', and you use it at your own risk. The contents of all 'Chat' messages should not be construed as advice and represent the opinions of the authors, not those of London South East Limited, or its affiliates. London South East does not authorise or approve this content, and reserves the right to remove items at its discretion."
https://www.lse.co.uk/chat/general/help-and-feedback/posting-history-3B333383-3C95-4A79-9954-B19C3B7627F0.html
Medusa 19 is a start up private company building from nothing so expectation is probably a careful build up keeping costs down. It was a director? doing the home use tests near Manchester . BooHoo owners bought into AVCT so they probably expect big things and a source of many LFTs for different ailments/indications to flog at Medusa 19. They can afford to be patient but increase capital when opportunity emerges.
The US have swerved from chinese and their main manufacturer ceased production for a time so the opening is there for supply to be bought via a simple conversation, not adverts. You can't keep a good man down and maybe AS has been more vociferous in private than we know about explaining the pivot from UK focus.
GaryB-Hanvey said the CTDA was an additional barrier since November? in a most exasperated tone- he really did very well by current MP standards at delivering detail. AffiDX was approved following CE mark following Carlos 111 clinical validation but the public consultation had around 80% support for the new British oversight. 80% of contributors to this public consultation were most probably on the gravy train and managed to extend their monopoly and thwart in use validation of AffiDX a few weeks after the momentous professional approval use in the EU. This what AS said about it in the RNS "This is an extremely important step forwards in the commercialisation of the AffiDX® antigen test"
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.