Sapan Gai, CCO at Sovereign Metals, discusses their superior graphite test results. Watch the video here.
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Indeed if you look at the flow chart for approval on the last page of this guidance doc:
https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/978379/Device_Registration_Reference_Guide_April_2021_Final_v1.pdf
...You see that in having Mologic submit the initial device registration, we skip the step of requiring approval for a new manufacturer, which might otherwise add time if we were doing this ourselves.
And good point Scardey, thanks!
@timster its very possible to fail at this point but given the submission was put together by Mologic who have been down this path many times before i am confident that this one will be successful. It was actually this that persuaded me to invest here having been previously sceptical.
@tecbadger is it also fair to say there is no way to fail at this point? It's literally a review of a document. I suppose there may be some amendments required but that's it?
Don't forget Cautious, we have our own reserved capacity with GAD, which is distinct from GAD's govt capacity. So, we can sell to anywhere in the world immediately, if we want.
In my experience turn around time of a confirmation of conformity from MHRA takes days rather than weeks provided the technical file is complete and documented appropriately
PL - exactly.
Bang on PL. And as Livedataaccount says, initially GAD are producing, and they have the contract to supply HMG. Sales to Europe might have to wait until TT to BBI and Abingdon (and whoever else, tbc) is completed.
Bein, hang on, didn't PresAl say the only route to market in the UK is via the govt? Why on earth would we care about MHRA approval for sale in the UK? Unless.... could it be true... is.... it.... us????
Pigster, I've considered that myself, I was wondering if a bottleneck could be their legal team, there's always a huge amount of pain staking work to get contracts signed and sealed. Hopefully a chunk of this had been done and was just contingent on the other parties being satisfied with performance - which they now will be, and so it is as simple as having enough ink.
It’s a double-edged sword though, having a new and better test, but not being able to supply it to everyone.
Until such time as the UK test is scaled up to the point it can meet all the UK demand, the government can’t pooh-pooh the existing test stock too much, because they will have to keep supplying it alongside AffiDx for some time.
They can (and no doubt will) shout about the sovereign manufacturing capacity, as it swings into motion on the eventually approved test. Will they talk up its quality? Perhaps, alongside supplying it into the highest risk settings initially (incoming travellers, outbreak/VoC surge testing?).
My guess is that there is a whole bunch of paperwork that needs filling out. Let's say it takes ten people a week to fill out. There'd be just as much paperwork for the UK as the EU as the US etc. You can't just put 30 people on the case as Abakta don't have the manpower, so you prioritise. If the HMG are saying, "Get the paperwork in and we'll drop an order deffo. Just look on bidstats, it'll all there waiting for you." then they go first, the EU, US can wait, even if they might turn out to be bigger. You'd got with the confirmed massive order rather than a possible mahoosive order.
Spot on roundhowe.
The Conformitè Europëenne (CE) Mark is defined as the European Union's (EU) mandatory conformity marking for regulating the goods sold within the European Economic Area (EEA) since 1985. The CE marking represents a manufacturer's declaration that products comply with the EU's New Approach Directives.
I believe the EU is where the twenty five expressions of interest are.
Onwards Avacta.
Scaredy - I posted this yesterday.
“...beginning Jan. 1, 2021, after the transition to the UK’s exit from the EU formally ends, any medical device, in vitro diagnostic or custom-made device “will need to be registered with the MHRA before being placed on the Great Britain market,” MHRA said.
The CE mark lets us sell across europe. We need MHRA approval to place the product on the UK market, alongside CE. Two separate things.
Why would we need MHRA approval if we weren’t confident of UK sales? And to get UK sales you need manufacturing capacity. Who’s monopolised this capacity? HMG.
The CE submission is European. The UK is still using it for about another year until our own testing gets under way.
Covid numbers are down but a majority of the population will probably have serious doubts about risking the fact in a tightly packed club or theatre or stadium.....without testing. The government will want a lot of stock for next winter and Christmas......the real trial for the UK.
Separate from UK. Are Avacta now in a position to sell into Europe? ce marked? There's been no mention of a ce submission to a European authority.
If GAD are the sole manufacturer, as of now. Surely the GAD tests will go to the government considering the massive manufacturing contract the government have awarded them?
Confirmation affimers detect the Indian variant would be a nice bonus
I doubt there will be any announcement of a sovereign test.
All the communication is: numbers are down, we're returning to normality.
The last thing Johnny taxpayer wants to hear is: we're about to spend a shedload on a bunch of tests we wouldn't need if the "numbers are down, we're returning to normality" message were true.
Hopefully, HMG will still be (quietly?) be placing an order for a bunch of AN tests. And if they don't, someone else should do.
Shortly in the coming days ...
So when do we expect our government to announce the sovereign tests or British tests?
They don’t seem to like talking about it very much?
Will the MHRA be getting a gentle kick from the government too if they are actually involved?
They are, as stated by AS in the investor presentation.
We are well into the midst of 'coming days'.
A kind person mentioned mhra sign off within 6 days.
I would hope GAD are already manufacturing the test.
https://www.lateralflowtest.co.uk/wp-content/uploads/2021/03/MHRA-Approval.pdf
This is from the MHRA in reply to an application to register the Flowflex LFD as discussed a few threads below, The application letter was received by MHRA on 25 Jan 2021 and this letter of registration is dated 10 Feb 2021. Hope Avacta are being fast tracked.. .
I would say this week! Otherwise it would be coming weeks??
Coming days I would say is less than coming weeks.