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I bet we don't get an RNS tomorrow (or at least an RNS related to our LFT, CE marking or ISO). Anyone wanna take me up on that?
To make it interesting loser has to buy 10 ODX shares, create a thread on their board called 'We love king Colin!' and offer to make Merchant a cuppa and tell him to put his feet up. Bit like Mother's Day. Except for a twat.
My understanding is that a CE mark is for the actual product.
What you call the product is up to the owner of the product.
Happy to be corrected but fully expecting the Affidx Sars cov2 rapid antigen test to be on sale this month.
Onwards Avacta.
That was my thought too, otherwise the whole Mologic CE marking exercise would be completely pointless and this sentence a complete lie:
"CE marking the test for professional use early in May followed immediately by commercial roll-out."
Thought I was going mad for a second there....
I've already said on the other thread to doze, ISO is not on the critical path. The product will be launched once Mologic have CE marked the test. This will happen 'shortly'.
As for the govt, they can crack on, the DPS isn't a closed book. I wouldn't be surprised to see the first lot(s) go elsewhere - after all, we haven't got a CE marked test yet. Also, they might want to go with more than one until they've been fully proven in the wild in a similar way to Phase 4.
Doze in that instance, what will the product be sold as when the test gets a CE mark under Mologic? The wording from the Results RNS suggests as soon as we have the CE mark, the test is saleable, are you saying it cant be sold under the AffiRx name until Avct have ISO and CE transferred?
"On the basis of these excellent clinical data, the Group will now complete the technical file, including accelerated stability data, for CE marking the test for professional use early in May followed immediately by commercial roll-out.
Avacta Diagnostics division expects ISO13485 accreditation early in Q2 2021
Avacta's Diagnostics division has completed the two audits of the Group's Quality Management System that are required by its external auditor in order to award ISO13485 accreditation and is awaiting confirmation of the outcome.
Within the consortium the sovereign test can use the ISO/CEmark or whatever else of its members to bring out the LFT at cost but AVCT need all their own to market AffiDX.
sorry Madusa dont have CE but ISO accreditation from my understanding?
Sure the BSI Website which is updated from 8-9am daily. Mologic is on there but avacta are not. I check regularly but as others have pointed out , the company might gain the qualification weeks before it is officially confirmed on the website.
Is there a database to see the progress or award of CE marks. Trying to look at the EU site but can't work it out. Thinking maybe we can gind Avacta's submission somewhere?
I do wonder that if there are 2 competing tests say - Mologic and Avacta and the DPS or £8b direct tender which is due the next day or so would rely on CE Mark, noticing that Mologic have offered to support Avacta on the CE issue as announced previously.
If its completing, Mologic could retract this offer allowing only Mologic to be the sole test that has CE, S&S and capacity to go. I dont think they would do this, but its a possibility.
On the other hand, if CE is needed and Mologic are producing, then they just cover that part off for a short period and we win the contract. I am not sure of the timeframes they can do this or whats involved but at present this is open for us to exploit.
I personally think the CE has taken quite some time since Madiusa19 has been spin up, have got capacity sorted or in the middle of doing so and already have CE as a brand new company. It is very disappointing we are still waiting. but this is my frustrations coming through.
CE Marking could be a mute point if its just a box tick that either we do ourselves or Mologic do for us. Its the orders that matter...CE for Avacta would be nice to achieve tho just so we dont have to get too in bed with Mologic and things get complicated on a contract level.
Zen dog stick to sailing your boat
Your jokes are S4ite
Seems like you cracked the same funny joke in your last 3 posts
Z, Yeah, heard you two days ago, .......rofl
Seems like the CEO may have meant early may 2022?
he said very early May for CE marking though and this will come when it is achieved regardless of any political events, I don't believe CE mark will mean any sustained rise to the sp as it is taken as a given any this stage but it is an important step in taking the test to market and I do think significant orders and sp increase are very close now
DPS award subject to CE stamp (within 2 weeks) could be what we see.
CE mark is required for the DPS Wiggly - so until we have that, AffiDx isn't going to be getting any share of the DPS.
However......should AVCT be only providing reagents (AffiRx) to the Govt, that may be a different ball game, who knows!
"Notwithstanding the flexibilities in specification described above, it is mandatory that any Test
must meet all applicable legal requirements enabling it to be used in the UK (or relevant parts
of the UK). We anticipate that in the vast majority of cases this will mean that the Test will
need to hold a valid CE Marking, CE UKNI Marking, UKCA (UK Conformity Assessed) marking,
or you (or the Legal Manufacturer) will hold a derogation granted by MHRA for that Test (i.e.
a derogation enabling its use notwithstanding the absence of CE Marking, CE UKNI Marking or
UKCA marking). However, consistent with DHSC’s objective not to foreclose the possibility of
other effective forms of Tests qualifying onto Lots within the DPS, it will be sufficient that meet
the Test meets all applicable legal requirements enabling it to be used in all or part of the UK.
A specific example is that it may be the case that other forms of legal authorisation for use
may be available for Tests to be used in Northern Ireland. "
I'm not convinced there will be a grand stand release for a selected government test. Quite possible they will select a few different tests.
I just hope for AS to confirm CE mark and forward orders
News will come when it comes we know Al's vague timescales are legendary. Even though he said rather ironically in the webinar that he can now be very accurate on timings :)
He said early May, it's still early May for a few trading days..
'doesn't pay to be so laid back'. Can you explain how your emotional state impacts the performance of the share price?
PL,
The gov wont be involved in our launch (unless we have been central to the development plan since day 1) but they will, according to ODX, announce the Sovereign test following the Scottish elections (which are taking place today). If we combine this date with the LFT announcement forecast tomorrow (ps - Bojo and MH love a Friday press conference) and combine with the fact that the first DPS award is also due tomorrow, then tomorrow looks like a key date.
If we combine this with AS 'very early May' then all could be linked.
" for self-declaration of a CE mark" Under Avacta/Global Access Diagnostics control be ready when it's ready .
"Completing the technical data set for self-declaration of a CE mark for professional use in early May, followed immediately by commercial launch in Europe""
""We are completing the necessary assessment of the product from our manufacturing partner Global Access Diagnostics, including stability testing that will complete the technical file for CE marking, which we expect will happen in early May."
"We are very excited by the potential of this high quality SARS-CoV-2 rapid antigen test and we are looking forward to updating the market as we commercially roll-out the AffiDX® test in the coming months."
Wiggly, why would the govt be involved in the launch of our independently launched CE marked LFD that will be sold throughout Europe and beyond?
Even if we are part of the govt plans, I wouldn't be surprised to see the first lots to end up elsewhere - as things stand, we haven't got a CE marked test... It would be beyond a miracle for Mologic and the govt to coordinate everything so that we get our CE mark just in the nick of time for Bojo and fwiends.
'saliva' for the fastidious of you lol
There's no 'deadline'. Covid is still rampaging around the globe and PresAl hasn't got a boss lurking over his shoulder, just a few whingers repeating the same stuff on here. Mologic know what they're doing and it'll turn up 'in due course' and as someone that's held for over a 'king year, that's good enough for me - can you imagine actually having an actual test that's actually been launched??