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@JoeyDiamond
Thank you for posting, it led to some thoughts that I generated here but I failed to give you credit for highlighting. So I would like to say as much here and now.
https://twitter.com/BigBiteNow/status/1291303433430093833?s=20
Apologies that should read "I cannot see how the AVCT LFT isn't sitting at "primary validation" stage.
@Spike66 I have just put together a logic in a series of twitter posts but in essence I cannot see how the AVCT isn't sitting at "primary validation" stage.
That would explain why there were no words about evaluation and clinical validation by CONDOR because it is a self validation stage with blind sera sets fed into it by the NIBSC.
The BAMS test is at secondary validation already, which i suspect is direct from NTAG Triage because they likely would have been an announcement if it was primary and because we know that the next stage as of 9th June for the BAMS test was
"evaluate and optimise the BAMS assay using patient samples at laboratory sites in the UK and US which will be done imminently"
Primary validation could also have been the same thing but I suspect AVCT would have made some noise about CONDOR the moment it was confirmed they were on board.
Whatever the case, if that flow chart is indeed correct, then the only way to gain access to patient samples from CONDOR is to be at primary validation stage, which as you strongly indicate invoves "advanced procurement talks for promising candidates."
There is always the chance that something outside the box is happening or the flow chart has been altered but the chances are for me minimal. Why would CONDOR go out of its way for 1 test and not make it do what everyone else is trying to achieve.
So i very much like that as an answer to the wording of yesterday's RNS.
Like I say, a great great find. This BB is at times very poor but your post is certainly a diamond in the rough of it all.
@Spike66 Thank you that is a really great find.
One other important point to perhaps appreciate.
SONA conducted their in-house lab studies prior to contracting MRI Global for the clinical validation studies. When SONA announced those MRI Global clinical validation study results, they also then announced their own earlier gamma irradiated studies.
SONA 22nd May
"The project work will take place in MRIGlobal’s Kansas City laboratories and will assess Sona’s test using live SARS-CoV-2 virus following its past, successful internal evaluation using gamma irradiated virus."
SONA 2nd July ;
"Validation studies were also conducted in-house to assess potential clinical performance of the test using 30 nasopharyngeal samples from healthy individuals who were presumed negative for COVID-19. Results from the study generated a specificity of 96% (29/30) and a sensitivity of 96% (28/29)."
Most importantly ;
2nd July again
"To generate the sensitivity data, the remnants of each negative sample were spiked with gamma irradiated COVID-19 virus"
SONA had already completed in-house lab studies that told them they could achieve 96%/96%, prior to going into an independent clinical validation study.
They did not publish these results because they are following the same rules that AVCT are now working against.
As I have discussed elsewhere, the general belief is that because AVCT have talked about transferring the prototypes when they are ready, to manufacturers they are in discussion with and that said manufacturers are due to be announced, that optimisation is ongoing.
What AVCT actually said was "as soon as we reach agreement with the manufacturing partners, we'll be able to provide more detail on the precise timeline for having product available."
The assumption is that is triggered by tech transfer and the completion of optimisation but its an assumption only.
Sona never stated optimisation was complete. What they did was announce an independent lab study on 12th May (so 1 month after optimisation started), which led to adjustments to the test design.
10 days later they announced MRI Global and the clinical validation study, which also triggered tech transfer.
SONA 22nd May ;
"The Company has begun technology transfer activities with secured manufacturers"
Some investors assume that optimisation is being drawn out and that means there must be problems but are they really sure that is what is truly going on.
AVCT is doing deals for patient samples with CONDOR for the very same LFT that is supposedly being fine tuned because its not good enough.
Are we really sure about that? SONA prepared for clinical validation because their own in-house, at the time unannounced results, told them they were going to get a very good result.
Why is AVCT any different?
@CautiousOptimist You don't have any need to apologise to me, we all have our opinion and should try to help each other with what we know. That is of course assuming we are all pulling in the same direction (not aimed at your good self).
In the time periods between updates, it is in my opinion important to stick to the facts and not allow ourselves to fall too far down the rabbit hole.
Yesterday's RNS ;
"Avacta Group plc (AIM: AVCT), the developer of Affimer® biotherapeutics and reagents, is pleased to announce that it has begun work with the UK government's CONDOR programme to evaluate and clinically validate the high throughput COVID-19 bead-assisted mass spectrometry ("BAMSTM") laboratory assay developed with Adeptrix (Beverly, MA, USA)."
The CONDOR programme will clinically validate the BAMS test, which means in accordance with MHRA guidance, and those results will then be published by CONDOR, which means AVCT will need to publish as well.
If you refer to the enclosed excellent tweet, then you will see what the BAMS test is at "Offers Evaluated" stage.
In BAMS case, this means a Technical Evaluation (TE) and a Clinical Evaluation (CE), not to be confused with the CE Mark.
https://twitter.com/buy_buy_bye/status/1285828035384672258?s=20
Further reading around the CONDOR programme allows us to understand that in-field studies will be conducted as well. Again CONDOR will publish these through MHRA and so AVCT would need to publish as well.
It may well be that all results come out in 1 report but the reality is, it is the results as whole that will allow these tests to sink or swim and not games played around timing of release. That short term trading related, which is not my bag.
For the LFT, all we know thus far is that CONDOR are prepared to allow AVCT access to live patient samples to allow the clinical validation to be completed "quickly." It does not say that CONDOR will be doing it.
However, what AVCT also say is that ;
"This, combined with other collaborations that we are putting in place, will provide us with access to a sufficient number of COVID-19 patient samples to allow us to quickly clinically validate the saliva rapid test."
So perhaps what we should all be asking ourselves is what possible collaborations exist that would involve parties that have access to live patient samples and where are they based?
Then my post wasn't for your benefit.
Some contributors both here and on Twitter, believe SONA have only released laboratory results and this justifies criticising AVCT for not doing the same, because these perceived SONA actions support such a move.
The reality is that SONA did not release such data until they had a a test that was clinically validated.
What they then did was reference their own earlier in-house work, which matched the 96%/96% results but that they could not share until the MRI Global results were available.
There is a rule book in play and AVCT are following it, whilst giving as many hints as they are allowed, through portals that are not so tightly controlled.
Apologies because my post may still have left some room for doubt.
The SONA results published on the 2nd July were the clinical validation results carried out in accordance with FDA guidelines.
There appears to be some confusion as to what stage SONA are now at.
To be clear, the announcement made on 2nd July, in which SONA delivered 96%/96%, were the results of the clinical studies carried out my MRI Global, in accordance with FDA guidelines. Hence why they published the results and were then able to sell their product for "research use only."
What they have now moved onto is an "independent clinical, in-field evaluation studies to generate the data to support its analytical and clinical data," which was decided upon after "consultation with MRIGlobal and the FDA."
This process is designed to achieve the same results that CONDOR are aiming for through their programme for the UK government.
SONAs results are not in-house lab results that were published prior to some expected further clinical studies.
@Tomvisual Again I think investors need to be thinking longer term and considering price sensitivity in their thought processes.
Until proven otherwise, Covid is going to be here for the longer term and vulnerable people are going to be at risk. Therefore, cost effective therapeutics are going to have a worthwhile market.
Therefore, sufficient demonstration by AVCT that their cheap, easy and quick to produce Affimers are a worthy option, is surely going to generate substantial interest.
There is as far as I can see no deadline for this as things stand. I also feel we are getting very close to a further update on this be it further evidence of the Affimers working or the 'big pharma' partnership, that has been talked about.
Said interest has the ability to deliver a in human trial faster than AVA6000 and in the hands of a large interested party.
So even if for some unexplained reason the treatment isn't required or effective enough, that milestone would be more than worth it, for what it would deliver for the entire pre-cision platform.
@mortgagefreeman To be clear, as far as I am concerned, exact timelines are not truly relevant. A successful test that can capture a sufficient amount of the market it is intended for + actually having the market there when it is ready, are all that truly matters.
Right now AVCT is very much on for both but the test performance, which is influenced by this optimisation process, is the last big hurdle and is worth the time being applied to it.
That aside, you will not find a reference to actual time to market other than "as soon as possible in Summer, so middle of Summer."
We can debate this point to death all we like but realistically, we are talking 3-4 weeks behind this estimate. That is absolutely fine with me.
The main reason being that this product is going to generate long term recurring sales for AVCT. Yes front end it can exploit a bigger market but the month or so we are discussing, is pretty much irrelevant.
Any treatments that come along require higher performing POC tests to assist them in finding their targets. They require ongoing POC testing to ensure that the numbers don't overrun the very healthcare systems that will administer them.
Any vaccine that comes along, if in any way possible it is able to deliver 70% herd immunity across the whole world, by countering those persons not willing or able to take it, which means a vaccine that can deliver efficacy considerably higher than 70%, is going to require higher performing POC tests, to supplement the time needed to deliver it fully to market and then to monitor its effectiveness, given its expedited clinical process route.
Anything short of the above and the need for testing is amplified. Any delays in getting a vaccine to market (note the Oxford team caveats on by end of year now and not Sept), is going to extend the need for that same POC testing.
A strong AVCT test candidate with its cost advantages (which will be important for when price sensitivity and market competition eventually kicks in), is going to have a very good run at this market, even if it comes to market in Sept/Oct.
In reality, the vaccines are likely going to come up short because the percentages are against them. They can save time but that does not assure quality. Therefore, Covid is highly likely going to be endemic.
Furthermore, the most vulnerable in society, those being most likely to die from Covid, likely will never gets enough benefit from a vaccine. So they are going to need to be protected through effective treatment and testing.
I think the market is slowly starting to get that fact but it won't truly happen until said vaccine begins to be distributed and we see the realities on the ground.
I'm going to post the quote again because reading back, I may not have explained myself very well.
What Dr Smith was saying on 12th June was that the actual important milestone, is the proving the test works with real patient samples, not the delivery of the first prototypes from Cytiva, because they 'only' employed model samples.
That process began upon delivery of the prototypes on 24th June and must be completed prior to going into pilot batch manufacture.
In my view, that is not purely an optimisation phase be it that is what it is called.
"its an important milestone of demonstrating that the test works with real patient samples and then going into a phase of manufacturing, manufacturing a number of batches to allow us to go into clinical validation and then of course regulatory approval to allow us to get a CE marked product, as soon as we possibly can in the Summer."
Proactive presentation 12th June (1 hour 47mins in) ;
"we anticipate having prototype devices by the end of June that will have been tested with models systems and be ready for testing with human samples"
"its an important milestone of demonstrating that the test works with real patient samples and then going into a phase of manufacturing, manufacturing a number of batches to allow us to go into clinical validation and then of course regulatory approval to allow us to get a CE marked product, as soon as we possibly can in the Summer."
If investors review the Sona Nanotech development timeline, as explained through their news updates, they will see that Sona entered the optimisation phase shortly before 13th April and then delivered almost exactly 1 month later "confirmation from an independent laboratory" that their test "achieved a positive response to a recombinant whole spike protein control reagent specific to SARS-CoV2." The main problem that Sona had is that somewhere along the way they decided to firstly employ "virus samples that were de-activated by heat" and these "did not provide a response," which means they lost time.
These two development routes aren't exactly the same but they are both being driven by Cytiva and as demonstrated above, AVCT have set themselves up from the start, to employ live patient samples, once the prototypes were ready, which Sona only introduced for the independent clinical trials, which they commenced on 22nd May.
Everyone will and should have their own take on what the information is saying but what is clear is that optimisation is a recognised part of the process, so is not additional time and it is not simply a case of focusing in on the test performance but "refining" it through the use of actual patient samples, which could not be done until the prototypes were ready.
Furthermore, it is clear from the 12th June presentation that this was always part of the plan and part of the path to achieving a validated CE marked test "as soon as we possibly can in the Summer."
Therefore, the argument that time is somehow being wasted is for me absurd.
Now it may well be that a little time has been lost along the way. Those with project management experience I am sure will vouch for the fact that the vast majority of projects, do not meet their original target dates but it truly isn't relevant to the bigger picture here.
Taking a couple of weeks to optimise and actually completing further laboratory tests, aren't the same thing.
In my opinion.
Fortunately I only read these BBs occasionally now and I am grateful for the time it saves me.
@alwayswinning You appear to be on a quest to be understood but in my eyes you regularly deliver confused arguments. However, as I say, I am not always able to read this BB so perhaps I have missed your better points.
What worth does it have to try to tell a BB of investors that AVCT has "shifted attention away from the LFT the minute the placing was done and dusted" when 99% of them known fine well, that AVCT released an educational video on "diagnostic test performance" some 3 weeks after the placing was completed, which itself explained the process for delivering the LFT and the expected outcomes that such an LFT should deliver.
With such weak arguments, I'm sorry to say that you are certainly going to continue to fall short with me and I find it difficult to respect your view on events.
One serious consideration here. The assumption that optimisation is the only process that is being progressed right now, is highly likely the wrong one.
Since the 4th June placing was confirmed, AVCT has ;
1. Achieved a working prototype for its BAMS test
2. Achieved a working prototype for its LFT
3. Has delivered independent proof that its neutralising Affimers work
4. Signed an additional Affimer agreement with Integumen
In addition, CEO Dr Smith has delivered 2 investors presentations, an investor interview and most importantly yet another video designed to educate and inform investors, on the next stage of development for the LFT.
Furthermore, David Wilson, AVCTs head of diagostics, has had an article published in the July issue of EBR, which explains the reasoning behind the two pronged attack on testing, from AVCT and remains relevant at that later stage. That being during the optimisation and evaluation phases of both tests.
In my humble opinion, there is no justification whatsoever for turning all that hard work into a criticism of AVCTs efforts.
Most importantly, the diagnostic test performance video could not be more clear in its message.
Released the day before Cytiva delivered a working prototype with laboratory performance data, it clearly stated AVCT's own "minimum hurdles for a rapid antigen test for use in the general population" being "sensitivity >90% and specificity >95%"
There was no need whatsoever for AVCT to produce that video and certainly no demand for them to state that minimum requirement. The placement was done and dusted 3 weeks prior to this.
In my opinion, it is absolutely clear that AVCT would only release that video and state such a minimum position, if the prototype laboratory performance supported it.
In every investment doubt can always be justified. Some crazy outcomes can occur when we least expect it. So an argument can be made that Dr Smith and his team are stretching the truth or getting carried away with what is possible but it is most likely the opposite of that. That the prototype is already hitting that minimum mark or better and that AVCT truly are ;
"aiming to have the highest possible test performance" and it is a level well above their own minimum hurdles.
This is further compounded by the fact that on the "Antigen test development pathway" AVCT says very clearly ;
"A number of processes, such as. . . manufacturing scale up, will be run in parallel with clinical validation"
Will be not can be or if test performance is adequate enough to meet the minimum standard etc etc.
He is stating will be the day before the prototype laboratory test data is announced to the market, whilst making it clear that SENS >90%/SPEC > 95% is the minimum hurdle.
Its abundantly clear to me why these messages are being delivered to those very same investors who some think are supposedly sidelined.
I have been investing for many years and the way AVCT has managed the education of its shareholders, through what is a true one off experience, is to be commended not criticised.
@RorkesDrift I would say that UK must lead the policy on this otherwise private care providers will cut corners.
So I can see incentives being put forward to encourage regular testing.
At the end of the day, the biggest sales point that the AVCT test has, is its ability to significantly reduce PCR testing requirements. So governments, agencies, healthcare authorities etc that are currently spending heavy on this, are going to be drawn to these tests, PR or not.
That's why AVCT posted that piece on 14th July because it demonstrates the effectiveness of the mass screening angle. To date it has not been an option but it is looking more and more like it is coming.
Plus Medusa are already offering a contract supply for business with the statement ;
"Medusa 19 will offer a contracted supply for businesses, allowing your business to receive the number of tests you need regularly over a period of time."
Yes its only on a somewhat inactive website for now but that will change.
@PL75
From the 20th May update ;
" Medusa19 will also have non-exclusive rights to supply the tests to businesses for workforce testing."
Medusa have every right to chase the B2B market as hard as any one else. Whats interesting is that they have to share it with other currently unknown parties.
I employ Medusa as the example because they are the only one we know about to date.
Its not really about them, its about answering your point about the market demand for DTC/B2B, which should be very substantial indeed.
There is an important question over European markets and their willingness to simply accept the CE Mark (a European standard), a CE Mark and a UK in field validation, or something more localised.
However, its simply process that we are talking about here.
AVCT can access that European market if their test is good enough. So the 1.2m example can be magnified considerably across those 27 or so countries.
@PL75 I think you are underestimating the DTC market substantially. There are numerous examples of major companies with very deep pockets, who will seek out this test for their employees this Winter.
I would also think the UK care home market will be a big and a longer term market, given the fact that vaccines are notoriously bad at protecting people over 70.
60% of UK care home residents are over 80 years old.
1.2m people work in the industry, with a split of ;
465,000 working in UK care homes
610,000 people are providing care to people in their own homes.
150,000 provide day and community care.
If the UK follows the consensus in the report that AVCT posted on 14th July, that testing every day/3 days, reduces infections by 60%, then those 1.2m workers may well find themselves being asked to take a POC test, twice a week.
A good portion of that will be DTC sales. That alone could deliver 10m tests a month.
Not all DTC but nevertheless a significant market for someone like Medusa 19 to chase.
A great many of them aren't working for the NHS. They are private businesses.