Member Info for jdt1990

The RTC seem to disagree with you Wyn and why does this have to be purely Covid related? The longevity here could well be in using LFT's for various other viruses/diseases etc.
It's pretty clear to avoid this happening again at the same destructive levels on so many fronts, that a regime needs to be in place to nip it in the bud ASAP. Vaccines and anti virals don't provide that first line of defence.
https://www.ft.com/content/c9565eb8-4250-495c-bce9-93d786e3bb9f

Agreed June could be a big month for Vela. I do wonder if cash has been held back should it be required/useful for further investment in the trial post results (if good).
Nice to this spring into a bit of life finally!

I just had to pay well over ask at 12.37 for my top up

100% zoom it’s not on the critical path in the sense everything else can continue around this whole MHRA debacle (which only affects the UK market remember).
If we had MHRA approvals we would still be sat here waiting for Europe orders and a potential update on UK gov situation.
Therefore in the grand scheme of things (although frustrating and I would love Avct to just say it how it is first time round rather than leave us all guessing) this is a bit of a non event and doesn’t hamper progress to the real end goal which is signed contracts.

Exactly that Mr A. It's pretty clear AS is 99.99999% sure this test is getting to market (ok the question on when and the answer "soon"). However, GAD wont have stopped producing tests. They'll be stacking up in the warehouses ready for delivery a soon as contracts are signed.
All it means is there will be more available for instant delivery.
Also, what has been misconstrued is the "place on the market immediately part". That doesn't mean sell tests to generate revenue instantly. Remember this is for professional use initially so its just going on Medusa website for Joe Bloggs to buy. It's large scale buyers. This whole debacle clearly hasn't stopped the relevant discussions continuing and possibly having contracts ready to ink once approval comes through.
If you put your house "on the market", its being advertised, it isn't "sold" instantly.

Almost certainly. AS even said in the prezzo that since LFTs are being given away for free by the Uk Gov, the only route to the UK market is through them.

I’d also suggest having a read through this thread as BBN explained the European situation much better (given he’s based in Germany) and how access to that market will work.
Some good info in there
https://mobile.twitter.com/BigBiteNow/status/1398190826082164737

You think Avacta would associate themselves in any way with Innova? 10000000% that would never happen, just think about it, the fundamental Affimer IP covers both divisions. Here's a hypothetical conversation for you:
Person A: "Oh okay, you have an amazing oncology drug to reduce the impact of chemotherapy, sounds great. How does it work?"
Avacta: "Well it works by (see presentation from AS for full details) using Affimer technology in part"
Person A: "Oh Affimers....yeah I've heard of those. They were the the things in those Covid lateral flow tests Innova now make when you sold the diagnostics division to them"
Avacta: "Yeah but we made a load of money and its still Affimer tech in Innova branded tests"
Perosn A: "Nah sorry that's Avacta's entire IP rubbished because it's now associated in a small area of their business model with Innova, who made cheap, unfit for purpose lateral flow tests in that pandemic we had"

Never ever going to happen. Innova were clever and opportunistic i'll give them that but the quality of science Avacta produces would not associate themselves with a money grabbing middle mad who came from nowhere in a global pandemic.

Spot on mikey some civil service jobsworth trying to justify a title and couldn’t be ar sed to just shuffle some documents around to resolve rather than “rejecting” it.
Who’d have though there was a global pandemic going on. More red tape BS but if it’s true hey ho we know it’s not the test just admin and hopefully this is all sorted PRONTO!
Sure the time consuming parts of the process already done anyway and it really is a tick box exercise now!

AS might pay the extra fiver for the fast track now! Us Northerners love to save a few pennies but it bits you in the bum every now and then!

Well if it’s fake - he’s in a lot of trouble and if it isn’t fake and he traded on it he’s also in a good bit of trouble.
Agree he’s been subtly negative over the last few days but that may just be the impatience like many.
Very hard to know what’s gone on there.
Either way Avct have to comment nowi think. Stifel and Avct tagged in the tweets.
Thats one way to find out what the hell is going on!

https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/948316/Conformity_assessment_routes_chart_Nov15.pdf

Found this on the govt website and it looks like for IVD's which have sterile elements / a measuring function there is an assessment element required by the notified body. AffiDx has at least one if not both of those, so could explain time taken if they have a backlog of the things at their door.

That’s what I’m struggling with here livedata. We knew the uk mkt access was slow as only via uk govt at the moment. As said that himself and as a result target market was Europe.
So why are we sat here waiting for MHRA approval which will only allow product to be placed on UK market and not selling to Europe in the meantime?
No mention of a EUR equivalent body working on authorisation/approval so either there doesn’t need to be one or it’s behind schedule.
FFS Al I’m starting to get sick of trying to piece the jigsaw together just tell it for what it is.
Test on the market in may was his prezzo comment so he’s got just under 48hrs to pull this off.

As made it fairly clear in the prezzo that whilst they are giving away free tests the only route to uk market currently is via the govt. Today’s revelations show the govts ineptitude and looks like Innova will take that for a while.
Hence the focus on Europe as the door to the market isn’t closed.
Funny how the MHRA conformity assessment will only be valid for product on UK market so I bloody hope there is something going on in the European space to fulfil that claim.
2 days to meet his on the market in May claim. Come on Al pull something out here!

Could have had 2-5m per day by Sept 20 if they had taken LFT/LAMP testing seriously. PHE/Civil service shambles.
No wonder AS went to Europe! Demons coming out of the closet now!

Thanks Myles - would make sense, someone needs to give it a once over somewhere in Europe by the looks of it to get entry onto this list.
https://ec.europa.eu/health/sites/default/files/preparedness_response/docs/covid-19_rat_common-list_en.pdf

"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 EU2
. The Council Recommendation called on Member
States to agree on three concrete deliverables:
1. A common list of COVID-19 rapid antigen tests that are considered appropriate for
use in the context of the situations described in the Council Recommendation, that are
in line with countries’ testing strategies and that:
a. carry CE marking;
b. meet the minimum performance requirements of = 90% sensitivity and = 97%
specificity; and
c. have been validated by at least one Member State as being appropriate for their
use in the context of COVID-19, providing details on the methodology and
results of such studies, such as the sample type used for validation, the setting

1 https://ec.europa.eu/health/sites/health/files/preparedness_response/docs/common_testingapproach_covid19_en.pdf
2 https://data.consilium.europa.eu/doc/document/ST-5451-2021-INIT/en/pdf3
in which the use of the test was assessed, and whether any difficulties occurred
as regards the required sensitivity criteria or other performance elements.
2. A selection of rapid antigen tests of which Member States will mutually recognise
the test results for public health measures.
3. A common standardised set of data to be included in COVID-19 test result
certificates, further facilitating the mutual recognition of COVID-19 test results. "

The AVCT test instructions from the annual report
https://twitter.com/glr_1990/status/1397121918432595968

Yeah makes sense Ben fair enough.

What's still niggling in my head is that it's made very clear on the Gov website that the MHRA can only provide the conformity assessment for placing IVD's on the UK market, not Europe.
There is no mention of any equivalent assessment being done by a European equivalent body. So surely that means it is not required and the process is fully self certified, meaning we have a CE mark that can be used in Europe?

Well I think the rational explanation for the CE delay was that AVCT were going to go it alone expecting to have the ISO accreditation all sewn up in early April. The Covid outbreak at Wetherby delayed that second audit so we had to go back to the Mologic plan.

Fully agree this game of Cleudo is a bit ridiculous. Just trying to make logical links to the Miton comments at 5:20 where it says CE marked, on sale, question is how much can they deliver not will they get customers.
https://twitter.com/**********/status/1397110515311255553

So to me that suggests it's could be a case of looking at these separately. The UK market has a different process with the conformity assessment element (one RNS) and AVCT are already out looking for buyers in Europe (another RNS).

I would think AS would have RNS'd the CE mark after this whole debacle. So that either means we should have just deduced that from the last RNS or it hasn't happened - but Miton today suggest it has.

Jeez this is the hardest jigsaw to piece together ever!!!

And by my post (long winded on reflection)I mean:
Maybe the only hold up MHRA is causing is for the test to go to the UK market (which the only real access to as AS said is via the govt). The CE mark has been done, self certified and the test is "on the market" in Europe. Next step is a buyer.