Member Info for doze

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.

Pre-sold stock to someone in bulk?

Enough of them get together in a cabal and they think they've 'invented the wheel'

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.

Saliva was always my preferred method and would have done an acceptable job but for PD not really understanding the R rate and pandemic control at that less than one. Surely I can have a moan at the idiot boffins to ruin their Christmas. Not to mention the probable vested interests in the Innova test and vaccine rollout.

Is this a wind up. It certainly is for AVCT who ditched the saliva test for mid-turbinate on UK preferred method now almost at market however a switch to saliva now advisable. Maybe Meduflow will not be needed as Medusa have their RSPT though as an antibody test maybe that won't work either. Can AVCT resurrect the saliva test at Cytiva?

Why have HL got the SP at 115p; a big hit to my holding.

Hi Eastside, Merry Christmas! I do agree with you but the £s speak quite loudly for them.
If the EU conformity list shows the commercial name as Meduflow I am assuming Medusa will be the manufacturer but still guesses for me. I am referring back to Mologic/GAD who seem to have hightailed it with their affimer test for low cost manufacturing on the back of their ISO so assume Medusa can do with Meduflow what they like but will be sharing the profit in 50/50 partnership.
The diagnostic team at AVCT I see as having great potential and brains and the IP but Gates/Kamani knowing how to leverage it. AVCT with the new commercial appointments might build the retail up in the future but I don't see them as enjoying a huge logistic/distribution business to distract from the science.

If it was not for the rspt the Medusa team would not have been up to speed and have the contacts in Spain and aswell as that they will likely have many different tests to sell if their business expands just like bioserve. They are a fully integrated business; biotech to manufacture to retail with their rspt which is more than AVCT can claim. The recent rns reads as Medusa being the senior partner in many respects. AVCT do not dictate to Medusa.

I have posted before that HUA is a box to be ticked in the evaluation and note the 'Completed validation studies' column is the equivalent in the EU and notes at 2 show that the Paul Ehrlich Institut do them. The Germans have a compliant population largely and have been super efficient with their processes. https://ec.europa.eu/health/sites/default/files/preparedness_response/docs/covid-19_rat_common-list_en.pdf
So AVCT have that box ticked but unsure what will appear in the 'Completed validation studies' column and whether Medusa's lay studies provided this data. It is confusing things when AS uses validation in a different context https://www.lse.co.uk/rns/AVCT/clinical-validation-of-affidx-lateral-flow-test-cq0zbg851uwxx1a.html . This column 'Clinical performance As reported by independent validation studies' in the ' A common list of COVID-19 rapid antigen tests ' link above refers to 'In Vitro Characterization and Clinical Evaluation of the Diagnostic Accuracy of a New
Antigen Test for SARS-COV-2 Detection' and the column should be headed 'evaliation studies' https://www.iomcworld.org/articles/in-vitro-characterization-and-clinical-evaluation-of-the-diagnostic-accuracy-of-a-new-antigen-test-for-sarscov2-detectio.pdf
It all just shows how the regulators don't understand what they are doing and contrive to confuse issues and the EU are probably worse than UK. Generally speaking the whole pharma industry needs to be made intelligible as all good science is life enhancing and inspirational, not confusing.

Evaluation and device ID yet to be delivered I think, last update just missed 21/12/21 https://ec.europa.eu/health/sites/default/files/preparedness_response/docs/covid-19_rat_common-list_en.pdf
The nominated authority (in Spain/Carlos 111 hospital?) has validated the test and it is for professional sale in the EU

UK till 1/1/23 that is but when validated just the usual periodic review of products in the EU