Member Info for jdt1990

Only wet firework round here is you bottmzup - what's your problem. You've upped the embarrassment stakes for yourself the last few days, still crying because someone rightly had your BS posts removed?

And the CE marking part. So CE mark will cover UK and Europe. We still need one if going for the govt tender as that is explicitly stated as a necessity to apply.
“We will continue to accept CE marked devices on the Great Britain market until 30 June 2023. This applies to devices that have been CE marked under and fully conform with the following applicable EU legislation:

Directive 90/385/EEC on active implantable medical devices (EU AIMDD)
Directive 93/42/EEC on medical devices (EU MDD)
Directive 98/79/EC on in vitro diagnostic medical devices (EU IVDD)
Regulation 2017/745 on medical devices (EU MDR)
Regulation 2017/746 on in vitro diagnostic medical devices (EU IVDR)
From 1 July 2023, new devices placed on the Great Britain market will need to conform with UKCA marking requirements.

If you currently CE mark your medical device on the basis of self-certification, you will be able to continue to do so and place your device on the Great Britain market until 30 June 2023. “

Goldstandard, looks like a CE mark covers UK sales until 2023 according to govt website. It also says on the tender docs CE marking is a prerequisite so don’t think there’s an immediate need for UKCA marking, which is good!
“ Manufacturers can use the UKCA mark on a voluntary basis until 30 June 2023. From 1 July 2023, a UKCA mark will be required in order to place a device on the Great Britain market.”
https://www.gov.uk/guidance/regulating-medical-devices-in-the-uk

Patelaz - Yes the UK is in Europe geographically but there was this thing, Brexit? Avct refer to them very distinctly. Hence why investors do the same e.g
“ Avacta Group plc (AIM: AVCT), the developer of Affimer® biotherapeutics and reagents, announces that it has received the first data for its SARS-CoV-2 rapid antigen test from ongoing clinical studies in Europe and the UK. ”

Don't forget up until recently the dominant strains were different in UK and Spain so I think the two distinct CV sites were for that reason.
Again, removing any opportunity for the tests to come under negative press when on sale.

Yep and using AN is more than likely to produce more consistent results in the real world setting.
The exact issue Innova have with clinical Vs real world results. A nasopharyngeal test given EUA for at home use, who is really going to poke their brains or their kids brains out properly if allowed to do it unsupervised?
Avacta's AN tests should yield much closer clinical V real world results.
GAME CHANGING!

Agreed PL - I don't think they have made enough of a point about these results being achieved using Anterior Nasal swabs. They've not just blown competition out of the water in terms of S&S but do it using a non invasive sampling method which is clearly harder to do.
The results are unbelievable!

Bump - at least a few of us get it PAH!
Building s skyscraper doesn't happen overnight and the foundations for a brilliant business model are being strengthened day by day.
Rare you see something like this on AIM - a company built properly and for longevity. Then you add the fact that the Affimer IP is being further endorsed day by day - which AVCT OWN!!

Self declaration, no mention of Mologic, wonder if we're going this alone and don't need to do the CE mark transfer now?
Maybe its a case of waiting the few weeks for AVCT's own CE mark is the same timeframe as what Mologic CE marking then transferring would take.

Christ wyndrum it’s 8:30 am!
Just remember not everyone has been engrossed in Avct for the past year, plenty will have never even heard of the company.
This further derisks the investment for holders and our resident “concerned” brigade but it’s going to take some time for it to get full traction.
Some may still want cold hard orders / others ce marking complete.
Everyone on this bb wants it all yesterday. Perfection takes time.
Anything ever satisfy you?

Such good news, we all knew it was coming just had to put up with the trolls in the news quiet period.
Congrats to all the LTHs and ones who have defended what this share has to offer. To all the “concerned” - time to shut up, to the tolls haha F You! To any who sold on the deramping it’s a shame but a lesson. To Visainn LOL!
Very interesting still nothing on CV in the UK site.
For me this screams Avct hand forced by govt but who knows?
Test on the market early May in Europe
BBOOOOMMMM!!!!

Probably this mart
https://novacyt.com/2021/02/02/launch-of-pcr-genotyping-assay-portfolio-to-detect-covid-19-variants/

It's a good point CO and we shouldn't forget the two very distinct trademarks AffiDx (the test) and AffiRx (the reagents)
https://trademarks.ipo.gov.uk/ipo-tmcase/page/Results/1/UK00003536447
https://trademarks.ipo.gov.uk/ipo-tmcase/page/Results/1/UK00003519801
AffiRx only listed on the register 5th March 2021. Clearly some potential demand for the reagents for it to be trademarked separately....just who?

They'll stay under wraps stodgy. The only place you'll really see the revenues will be on the income statements at each reporting period and even then it will be very difficult to decipher what the drivers are (unless explicitly stated).
The reason AVCT cant/wont disclose the commercial terms is because as soon as they do, that is the price set for the product. Keeping it from public knowledge puts the negotiation power in AVCT's hands for each future agreement.
It's like if I was selling two identical houses and one sold for £x, if my buyer of the other knew that, it's very difficult for me to be in the driving seat in the negotiation. The price has been set by the first sale.

https://www.telegraph.co.uk/politics/2021/04/10/private-covid-tests-subject-quality-checks-75pc-found-insufficient/
It's pretty clear to me that the larger CV was required to avoid coming under the scrutiny that many of the tests who CE marked on low sample numbers with dubious S&S claims have.
Larger CV using real patient samples (which is why IMO AS did it independently because PD use frozen positive samples) put its out to the public that these have been tested at scale in real world settings. Not done under lab conditions claiming S&S that will not translate into the real world (Innova). The issue as AS said is availability of real samples can drop which adds time, but it's worth doing properly.
It's about trust now and avoiding giving people like Deeks ammo to try and discredit your test.

As for the 8Bn - no I don't assume its all spent or will be spent. However, the fact they have tests available right now that they could be producing and manufacturers lined up to make them, yet haven't spent a penny of it yet is telling for me.

"But we do actually have to have a test"
We do have a test, it's trademarked and being put through CV - so it exists there is no doubt about that. AS said himself GAD are in a position to produce it right now. Do you honestly believe there isn't a test?
The fact its not being sold yet and we were told "around end of Q1" is a little frustrating yes. But all this talk of missing the boat.....farcical really.
I would be concerned if quality tests that have been put through stringent validation were flooding in, but they aren't. Govt have Surescreen and Mologic ready to go, but they aren't giving them contracts is huge volumes.
Radio silence from all the RTC and other companies is quite telling.
IMO AS's hands are tied to an extent but we shall see (or we may never find out the real reasons). However, the fact that £8bn tender is still sat there unfilled when the Govt have 2 tests they could be producing right now speaks volumes for me. Innova contract was outside of the DPS.
Uk Gov or Europe - this boat has not sailed yet.

https://www.statista.com/statistics/1196071/covid-19-vaccination-rate-in-europe-by-country/
Most countries on there will be looking at mass testing. Europe vaccination rates are generally pretty poor and a lot more hesitancy to have them in Europe.
Maybe the UK market slims down short term but its a big old world out there wyndrum where it isn't getting any better!

Agreed it’s all out in the open now which is good and plenty of positives to take from that RNS in that they are continuing to drill there. With everything they have going on, wouldn’t be doing it if not worthwhile.
Glad it’s out of the way before next weeks Hav update too!

https://www.londonstockexchange.com/news-article/GGP/scallywag-drill-results/14941851

TL....same to you bud and all the rest of the Avacta faithful. Not just that hopefully we all make a few quid but to be part of a company that could change the lives of cancer patients, something very close to my heart and the reason I invested here 4 years ago. GLA I think next week could be a great week.
Also- AS has done a brilliant job over the past 12 months don’t forget that on a SP and company progress perspective