Member Info for jdt1990

Think you’re right wiggly. There’ll likely be a lot of backed up deals waiting on the CE mark rubber stamp. When you look at what has got MHRA approval it’s 99.999999% this is a given.
Hopefully we’re rewarded for our patience and the floodgates open once approved!

Yeah it's nothing new, those are just the govt quoting/using WHO guidelines from late last year
"Conversely if the level of infection in a population is low, then a higher specificity becomes more important because it will be better at identifying the people that don’t have the infection than it is at detecting the people that do. The World Health Organization recommends that the acceptable minimum standards for tests should be 80% for sensitivity and 97% for specificity"
https://www.who.int/publications/m/item/covid-19-target-product-profiles-for-priority-diagnostics-to-support-response-to-the-covid-19-pandemic-v.0.1

TBH I would rather it this way than a PR machine spurting out drunk Tweets on a Friday evening like they have over at ODX....what's a few days when you've waited months and plan to be in here for a good few years eh!?

You do realise people can see your posting history dipsh it ....third time in a week you’ve pulled out that cracker. Jog on

https://www.newcrest.com/sites/default/files/2021-05/210506_Macquarie%20Australia%20Conference%20Presentation.pdf
Here you go

Sadly ladies and gents it's just a sign of the times we're in at the moment. A lot more of the Joe Bloggs public have access to the financial markets be that due to the time given by Covid or the access to easy leverage via spreadbets and CFDs.
With that comes a bit of naivety and those people look to the BB's for some guidance. Then, you guessed it, there is ample prey for the de-ramp brigade.
Some great posters here over the years (Pdub is one of those) and it's a great company....I haven't had much to say recently as Fortune is doing everything I believe he needs to (bar a bit of better PR maybe) and Ve prices just keep this flatlining a little.
For anyone struggling for some good viewpoints, BigBiteNow is a really good and well informed poster, his blog is below
https://www.bbnbigbitenow.com/blog

These bb's are swimming with "sharks", takes time to uncover them but they tend to pop up on other shares.

NOTHING is without risk but a bit of good research can help you determine that risk tolerance. IMO Bushvelds time will come.

Well the slides on the presentation did say commercial rollout in Europe will follow immediately after CE mark so fingers crossed the orders that will move the SP are not far off!

Yep spot on PAH and AS covered this briefly in the Q&A when asked about the process off adding new affimers to the test should they not pick up a mutation.
I think some thought each mutation would need a new Affimer but he explained the process would be relatively quick to do given affimers can be produced in a few weeks, however, it should be something that occurs very irregularly - for the exact reason you put very well below.
Avct have plenty of bases covered.
Again, although it’s taken longer, for me, it’s quite clear doing this right first time will have much larger long term benefits than the “opportunity cost” of not having a test out for a few months.

Well we know Mologic have been working with 2 companies with IP. Affimers and Aptamers. I know which one I would bet on it being if I had to!

https://atamis-1928.cloudforce.com/sfc/p/#0O000000rwim/a/4J000000kI0I/7JhImQT1H1UrqPqg4p59bRgE4blKhAA7Z4WmPeWJCZE

So when you look at 3.1.10 (regardless of if Mologic should/shouldnt have been redacted)
**If so required by the Test Developer procure that xxxxx enters into a contract on terms required by the Authority for the Test Developer to grant a licence to Mologic of the Licensed IPR and Licensed Know How to enable it to carry out
its obligations as legal manufacturer of the Goods and such other terms as the Authority may require; and**

So 3.1.10 suggests someone may be required to license IP to Mologic, but GAD won't have the IP. So could this be Mologic in their capacity of "owning GAD" and this is a legal structure....as that sentence reads to me like Mologic is the manufacturer of the goods.
Mologic wouldn't have to license it's own IP to itself...so for me, this is AVCT or another left field entity who are "test developer"

Bump to this.....global production capacity 120m per day and demand outstrips supply.
Shows the enormity of this market if they are worried that’s not enough!

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....

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.

Bitter they backed the wrong horse mate...

https://health-family-contract-search.secure.force.com/servlet/servlet.FileDownload?retURL=%2Fapex%2FProSpend__CS_ContractPage&file=00P4J00000FUY5fUAH
This bit stood out and had me thinking was it PD that confirmed that AffiDx picked up the SA strain, which AS announced in the prezzo?
Feel like this UK validation site we are still to hear back from is slow enough (or secretive enough) to be PD...
"Effectiveness against Variants of SARS-CoV-2
8.8 Potential Providers will appreciate that the essential objective of purchasing LFTs for
deployment as part of the national Test & Trace program by ensuring that individuals with
SARS-CoV-2 (in particular asymptomatic individuals) are identified. This objective will be
critically undermined if established and emerging strains (variants) of SARS-CoV-2 are not
capable of being detected by these LFTs. For the purposes of the DPS this is being catered
for in four ways:
(1) “Phase VOC Validation” which means the regime at PHE Porton Down to test the
‘sensitivity’ of Tests in the detection of established, emerging and new variants of
concern. Currently, at PHE Porton Down, there is testing underway to test the ‘sensitivity’
of Tests in the detection of the UK variant (also called 'Kent Strain', 20I/501Y.V1, VOC
202012/01, or B.1.1.7) and the South African variant (also called 20H/501Y.V2 or
B.1.351). "

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. "

Just wait til there's another 500billion warrants/special warrants/mates warrants/shaft PI warrants attached to the next placing to just add a bit more of a dilution kicker into the mix. Think that's when I will take stock and see if it's worth averaging down. £3.5m mkt cap with a project like that just shows how little confidence the makret has in LC.

Just to provide some balance to StarKnights “interesting company”, here’s a key competitor of theirs that’s worth a look - again very interesting concept but is actually practical, useful and helpful.

https://www.samaritans-purse.org.uk/what-we-do/operation-christmas-child/what-goes-in-my-shoebox/

Not to mention when turnaround times get longer again, taking a PCR test 48-72 hours per flight could be a struggle to get back on time. The basic principal never made sense to me though.
I do my PCR test 48hrs pre flight. That’s my pass on the plane. “COViD free”. What’s to say I don’t go licking COViD laced Petri dishes for 48 hours and I stay asymptomatic....but that’s fine I have my pass. Surely it’s a disaster waiting to happen and rapid testing on the day is the way forward!?
Then maybe a PCR on return to monitor for variants.

Not to mention budget airlines will lobby against it. Family of 4 to Benidorm. £400 flights and then another in PCR £200-400 testing. That’s their target market priced out and they don’t have the margins to fund it for them.....