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Note also that the evaluation is being conducted state side also, which of course supports FDA approval and US use.

Thank you Ophidian, sorry I lost your last response, hence the late reply.

Taking your list one step further and applying it to the BAMS test, would indicate that the initial live patient samples evaluation should be almost complete.

From 9th June RNS ;
"evaluate and optimise the BAMS assay using patient samples at laboratory sites in the UK and US which will be done imminently before moving to manufacturing, clinical validation to quantify the sensitivity and specificity and CE/FDA approval for professional use in the summer."

Looking at what GDR achieved with Cytiva post their collaboration, I would think 4-5 weeks would be enough to complete the process and get the product on sale.

So early August first sales?

Indeed Smallfry37.

As a starter for 10, a high performing AVCT antigen test, if achieved, can be very quickly implemented by the NHS, to establish who in the workforce has Covid right and get them isolated and away from patients and other members of the public.

It is a desire that will be repeated across a great many big business operations and will be repeated over and over again, throughout Winter. Thee is effectively nobody else who can deliver such a service, whether it comes out in Sept or not.

Exhibit A

"Dr Anthony Fauci, the top disease expert in the US, has warned that the US is "unlikely" to develop herd immunity to the coronavirus once a vaccine is available.

He said this was due to the combination of a vaccine that is only partially effective, and the large number of Americans who will refuse to get it.

Dr Fauci, who leads the National Institute of Allergy and Infectious Diseases, said he would happily "settle" for a vaccine that is only 70% to 75% effective."

And then it actually has to be good enough and rolled out world wide, to even attempt to achieve the herd immunity in the first place.

https://www.bbc.com/news/live/world-53216079

@wyndrum There is no first mover status when it comes to the rapid antigen test that AVCT are progressing. There is no other test like it on the market right now.

If/when AVCT confirm that it is good enough to meet its mass screening based roll out, said market will highly likely turn on a sixpence.

Employing SP fluctuations as a means to gauge market belief, is for me an error. This is a long journey to be had with many influences along the way, but ultimately it will come down to quality and market demand, whatever the market may or may not believe today.

A highly sensitive test that can be used at POC, to screen large numbers of people and vastly reduce PCR testing capacity and costs, is going to generate very high levels of interest.

Whilst I am here and having my rant, i would just like to point out how ridiculous an argument it is that Covid testing is somehow a thing of the past, or past its sale by date, or will be by Sept or Christmas, or even next year.

Right now, the only things that will vastly reduce testing needs, are Covid burning itself out and/or a vaccine(s) that gives the countries and communities, herd immunity. If it indeed exists. The head of the Oxford trial and Astra Zenica partner, has already gone on record as saying that 1 successful vaccine candidate won't be enough. They need several to conquer Covid. Until that happens, parts of the world will have a substantial need for testing.

The longer it stays, the more governments will want to push the responsibility and costs of testing, onto the private sector.

Time is needed to execute and with time comes SP games and a lot of noise but said noise doesn't change the reality, which is driven by the quality of the tests produced and the size of the waiting market.

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The mix of influenza with Covid cases is for me, going to lead to a whole array of employers, pushing for more testing. The events currently playing out in North Rhine-Westphalia, Germany, are a prime example of what can happen to a business, if it allows Covid into its workforce. It isn't going to be the last example because what this Summer will add to all of this, is further complacency, driven by over confidence as case numbers and Covid experiences fall.

That gives us a rather unfortunate mix as Summer moves to Autumn and the influenza season arrives.

Any one thinking that Covid numbers can be kept low without significant testing and social distancing measures, is in my opinion fooling themselves.

In terms of a vaccine, Astra Zenica (the most advanced) are talking a good game, with first deliveries stated as being Sept. As I explained on my Twitter feed, the head of the S.A. trial of the Oxford drug candidate, thinks best case Sept 2021, if a sufficient number of the trial participants are infected, so that they can analyse the data by year end.

With the US trial not yet under way and the UK trial, still enrolling another 10,000 people, it is difficult to conclude that a Sept roll out is possible. Add in the expected failure of vaccines to protect persons over 70 and the questions over how these persons will be handled (eg. dosing levels). Then add the question mark over efficacy. The add in roll out and the same tech transfer problems seen with testing. The same regulatory processes. The lack of trust for vaccines that are produced so quickly. All of which places the roll out of a successful vaccine under pressure.

In the case of the S.A. trial, that is forming the basis for WHO approval for lower middle income countries full stop and it potentially starts next Sept.

That aside, even a successful vaccine (>50% protected), still won't remove the need for POC testing. Tests that the easiest to use and help reduce the need for expensive hospital based PCR testing, that diverts resource away from other functions, will be the winners, which is why it is all about the quality of the test that comes out and not the exact date of delivery.

A residual worldwide market will continue, particularly in lower to middle income countries.

Progress on vaccines and treatments will continue to rock shares deemed to be Covid test driven because of the lack of understanding of the bigger picture but the reality is there is no switch. Everything takes time. The best policy was getting the numbers down in the Summer and initiating track and trace, which comes with substantial testing but some countries haven't even achieved that.

I'm long on AVCT because I can see clearly what even moderate success on these Covid tests, will do for AVCT other platforms and more importantly its industry standing. However, I am no fool to believe that is all fully respected yet, anymore than the opportunity in the Covid market is right now.

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If you are new to investing or perhaps not quite so well read up on your topic as perhaps you should be, then I would encourage you to invest more time in bettering your knowledge of your investment, than reading the mass of confused noise that is generated on these BBs.

The actual amount of true worth compared to the junk, means it is unfortunately hours wasted, that could be spent doing something else.

My opinion.

There is no doubt risk with AVCT as an investment, no investment is guaranteed to give you a return. Therefore, those taking a negative position, will at some point, always have a point and quite right too. It should help keep investors on their toes. make them check things.

The trouble is if you haven't taken the time to learn what the fundamentals are and how likely they are to play out, then these downward pushes on the SP, will lead to anguish and likely poor decision making. The same can be said for spikes and those that push them equally as hard.

As an investor, the key front end questions with AVCT are for me as follows ;

1. Will this test come to market and be of a quality high enough to achieve its goal as a mass screening tool for governments, health authorities, businesses and perhaps even individuals?

2. When it comes to market, will said market be big enough and long term enough, for AVCT to take sufficient advantage and generate profits, that make the risk involved worthwhile?

1. The underlying message and actions by AVCT, which concluded with the 23rd June video and 24th June RNS update, is that AVCT expects to deliver a product that will meet their own minimum expectations for a successful mass screening test. Time is required to execute but the path has been set. What's required now is patience and monitoring of the situation.

2. Anybody employing UK data as the basis for establishing the extent of the market is for me making a big mistake.
Anybody assessing the number of live cases as the basis for the future market, is again for me making a big mistake.

Any country with live cases of Covid is generally, at the very least, testing at the same levels they did, when they had 10,000 cases, if they indeed ever did. The vast majority of lower middle income countries, simply aren't testing enough and very few of them are going to be able to eradicate Covid or in my view, substantially reduce their numbers, without a sustained increase in testing, coupled with better quality products and lower costs. Said costs aren't just the test themselves but the additional resources required to operate them.

Countries such as the US have given themselves an even bigger headache because they have allowed their cases to expand during the start of the warmer Summer months, which makes their fight ahead of Winter, all the more greater.

Winter is going to bring its own set of unique headaches, which is going to drive POC testing and even DTC demand even higher.

Having said all of that, in the latest Directors interview, Dr Smith said ;

"Once we’ve optimised the test strip then we’ll have a design that we can transfer to manufacturers who we’re putting in place at the moment."

Hence my design freeze comment. That process was highlighted as being the end of June, just 1 day before the 24th June update on the initial positive results from the prototypes, where Dr Smith said ;

"we aim to have completed the optimisation very soon so that we can begin the transfer to manufacturers."

Take from that what you will.

@Ophidian Firstly thank you for your kind thoughts, all good here where I live thank you.

Understood. My impression has always been that no design would be passed to manufacturers until it was fully complete. Effectively the design freeze. After all we are talking multiple manufacturers here.

That being prototypes that are sufficiently complete to allow said manufacturers to "first of all" produce validation batches for clinical studies. I assume that these manufacturers have produced something similar before (eg. Abingdon) and in reality it is the strip that is the differentiating tech here.

As I just alluded to, 23rd June AVACTA video presentation ;
"we are now in discussion with a number of manufacturing partners, who will take the prototype design from Cytiva when its ready and firstly produced validation batches for clinical studies with patient samples."

I appreciate that there are other layers and no doubt several overlapping functions, which aren't worth a CEO explaining, but if anything that adds weight to the argument that the end of June tech transfer commencement is a significant milestone.

That all said, we don't need to labour the point too much. Thank you Sirius B for your response also. Whatever the case, I tend to agree that by end of August, the clinical studies and CE mark can be concluded. As I highlighted yesterday evening on Twitter, the key upfront market is the one involving healthcare professional use, which should be an easier path to market. If AVCT achieved nothing else but that with this test, it would in my view be a significant success.

I see no reason why that shouldn't be achieved by late August, tech transfer dates defined or not.

Hello Ophidian, I have a few points/queries, if you would care to entertain them.

The latest update from AVCT stated "work continues now to refine the test strip design, optimise its performance and get the best detection limit possible."

However, they were clear that the LFT is entering the optimisation stage.

In the diagnostic test video released by AVCT last week, the wording on the Antigen Test Development Pathway slide was ;

"when satisfactory laboratory performance has been achieved, the design will be transferred to manufacturers"

This was clearly marked as end of June on the slide, which is why I questioned the 24th June announcement being the actual update, as opposed to a step along the way. I could not logically conclude that such a video would call out the transfer to manufacturers as end of June, when the very next day this was going to be undermined.

In addition.

The 24th June update is clear ;
"Following the optimisation of the lateral flow test by Cytiva the design will then be transferred to manufacturing partners in the UK that are currently being put in place by Avacta."

I appreciate that optimisation is an ongoing process and that optimisation in a week would be very quick but in order to begin to transfer to the manufacturers for the commencement of "validation batch manufacturing," there surely needs to be a design freeze and that freeze comes after optimisation and AVCT are stating that commences end of June.

In all of this I am still a tad stumped as to Cytivas role. It was clearly stated in earlier updates (need to dig it out), that whilst Cytiva had large capacity, it wouldn't be big enough to satisfy the expected demand. However, that does not mean that they won't manufacture. That lends itself to the argument that Cytiva have indeed produced the first pilot batches and can therefore advance their version of the test without delay. I see no logical reason to deviate away from that plan. So front end real patient sample testing should not require tech transfer or as you have stated, it can be done in parallel.

12th June Proactive presentation ;
"we anticipate having prototype devices by the end of June that will have been tested with model systems and be ready for testing with human samples"

"it is 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."

So everything pretty much supports what you are stating, I am just querying the tech transfer point and optimisation time period because for me, its still be called out as end of this month, which sounds a tad quick, although the 24th June update did say ;

"we aim to have completed the optimisation very soon so that we can begin the transfer to manufacturers"

Thoughts welcome.

The idea that a CEO (who can be under no doubt as to the keen retail interest that exists in the company, given he would not be producing these educational videos for institutional investors), would publish a video ;

A. demonstrating the minimum standards the company itself feels a test for mass screening requires )90% sensitivity and 95% specificity) ;
B . demonstrating the sorts of parameters that a "high performing test" would need to reach (95% sensitivity and 98% specificity) ;
C. stating that the company is "aiming for a high performance test with both the LFT and the BAMS test ;"

the day before he releases the initial results from the prototype for his company's most eagerly awaited test, knowing it cannot possibly reach those sort of performance criteria, is for me beyond all sensible reasoning.

If the prototype hasn't demonstrated that it can (possibly with some refining) meet those self imposed minimum standards, then you don't release the video. It wouldn't just be foolish it would be a massively unnecessary PR blunder.

Is it still possible? Yes of course it is but then pretty much any outcome is in investing. That's why its about percentages and reducing the risk through research and analysis of as much data as possible.

That being the case, the law of averages tells us the exact opposite is most likely taking place.

That being that the results of the prototype were highly likely known long enough ago to allow CEO Dr Smith to make the video and plans its release. Yesterday's news release was the point at which they could publish the result to the market.

The video is designed to educate retail investors as the process develops with the understanding that not all data can be shared because here are rules that must be followed. Rules that the majority do not fully understand prior to invedting their hard earned.

My conclusion, having placed this update in the context of other available information , which includes the Labroots webinar, is that AVCT have a test that is suitable for mass screening and may even go on to be in the high performance category. However, that is not key here. Key is its ability to mass screen and therefore reduce the burden on health authorities through reduced workload and cost. Those attributes will guarantee higher sales front end, through professional use.

Then comes the over the counter market and with it Medusa. I would think that the people behind Medusa are already exploiting their many industry contacts and networks, to ensure that a sizeable order book is built up, prior to the official release of the test.

A test that is suitable for mass screening and gives businesses a risk profile that leans heavily towards increased business (more customers/staff returning), whilst minimizing potential litigation, is a winner and the combination of the video and the RNS, shout very loudly that AVCT are heading in that direction.

If the prototype wasn't completed, why would you sit down with your only other known competitor (Sona Nanotech) and discuss your manufacturing problems on an open forum?

This webinar is in my opinion, a learning exercise for future projects, employing recent completed cases. No company in its right mind would take part in such an exercise, prior to completing its own project and securing its IP.

Its no coincidence that both Sona and AVCT are both there, the only difference is that Sona have announced the completion of their prototype, AVCT have not.

There is clearly a lot of nervousness running through this BB and there are some that would happily play on it.

The presentation on Friday is not what is relevant here. What is key is that the GDR covid test was dispatched to prospective distributors and customers in w/c 25th May and first sales are expected by the company in June.

Whatever the wider markets feel for GDR is, they have a very good product that offers a competitive advantage to a world market that is still very much short of high quality testing.

I am also invested in AVCT and do not kid myself that the 2 companies are anywhere near the same in terms of future prosperity but at the the very same time, AVCT still has several hurdles to jump before its products are on the market. Where as GDR has already jumped them.

With 122k new cases recorded in the world just yesterday, which quite frankly is a small percentage of the true cases that current testing regimes are failing to capture, and further expansion of cases in a great many American states, Covid is far from done. GDR has plenty of scope to sell into existing markets that require more testing and also to dislodge existing tests, that do not perform as well or are more difficult to use.

All the company needs is enough time to execute. Yes there are one or two trust issues because of the placement and the team has to actually perform but with distributors already on board, even much of that initial work has been concluded.

The SP, as annoying as it is to see it drop, has nothing to do with any of that and will react to the news flow, as it comes.

Right now, GDR has to work pretty hard to blow this opportunity, be it that i recognise that even that, is possible in this game.

After talking themselves into an early grave today, perhaps some investors will find some relief at least, in the latest AVCT presentation, which gives further detail of the use of placing proceeds and some rather startling numbers expected royalties.

Note too the IND filing is now planned for 2020, driven in earnest by the approach made by our mystery US strategic investor. Thickens up the plot if nothing else.

Enjoy.

https://twitter.com/BigBiteNow/status/1270023472991875078?s=20

https://avacta.com/wp-content/uploads/2020/06/Placing-Presentation-June-2020.pdf

@BonesR619W I agree regarding the wider story and have myself been invested since prior to the Covid test announcement.

Clearly a successful Covid test could well mean substantial revenues, well beyond what the current MC demonstrates. So as you will appreciate, it is bound to take centre stage right now.

However, it is important also because the revenues it generates, have the ability to substantially de-risk the funding for AVCTs other bigger and potentially far more lucrative platforms, which in turn, potentially allows for greater value retention in them.

However, that successful test also helps demonstrate the strength of the Affimer platform at a time when a great many more eyes and partners are on it. So there is much to be more to be gained from this test doing what it says it will and well.

@Mookster AVCT have been clear that they will be securing further sales routes;

From the 6th May presentation ;

"we'll be putting in place other test strip manufacturing partners and OEM partners because the production capacity, considering what we expect the demand for this test to be, cannot be supported with a single partner.”

"We own all the commercial rights. So the types of manufacturing relationships we have will be either licensing and OEM. So a 3rd party can manufacture and produce the test under its own name."

I suspect the reason we haven't yet heard about further partnerships is because those partners perhaps want to validate the reagents, prior to signing on the dotted line. That they exist is abundantly clear because they have been sent reagents, which must be under some form of confidentiality agreement.

I have said previously that I like the look of SPD (JV between Abbots Alere and Proctor & Gamble) but there are a great many more options, if the reagents are as good as we are led to believe.

Its important to remember the speed and cost effectiveness, with which these reagents can be produced compared to competing technologies. That is a highly desirable edge that the likes of Alere will be keen to exploit for themselves but lets wait and see.

Yes Stanman I agree wholeheartedly and it is language that is often seen on very active shares.

However good an investment looks, however certain investors are in its success, it is a very dangerous game to be backing it to the hilt and anyone who encourages such behavior, is reckless with themselves because they are talking to people they don't even know, whose personal circumstances they aren't tuned into.

Any share can go sour at any time and we have to be able to live with the consequences if they do.

I believe very strongly in AVCTs chances of success but that is my opinion only and it is up to each and every individual to decide for themselves, by researching at thoroughly as they can. Blind trust in anonymous contributors will more often than not, lead to ruin.

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If you listen to the presentation again, you will note that this comment was made immediately after he spoke about those other test strip manufacturers. So AVCT have/are already providing Affimers to other (still to be announced) test strip partners.

Again, its a significant move to communicate that to the market prior to knowing how good your test is because without knowing the quality, one cannot be so bold as to call Cytiva out, for not having enough capacity to deal with the expected demand. An important signal in all of this.

Despite this, solace only comes once the words are in black and white, and in the meantime emotions will undoubtedly continue to play their games.

For me successful investing is about finding management teams that do what they say they will and don't tell me things that they then go on to fail at. That gives me the ability to dissect what they say and find more answers than I have been given.

Alastair Smith is a solid straight talking Yorkshire man who demonstrates confidence in his team and the abilities of the Affimer platform. To date, I trust what he says, such that these signals demonstrating the confidence are very much worthy of backing.

When he says very good, then I expect he knows what these Affimer based tests are capable of and that they will be good enough to deliver those high levels of demand, that he feels he can so readily talk about.

If so, then demand is not the issue here, which makes it all about speed of manufacture and delivery to market because if they are that good, then regulatory approval will be a formality.

Its important to keep one's feet on the ground and take things step by step but in reality, if we weren't invested and merely watching this develop from the sidelines, then the actions and achievements of the company to date, would make it clear, just how close AVCT are here. The trouble is those emotions will inevitably keep flooding back in, as the desire to keep finding problems persists, drowning the reality in its wake.

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Emotions play a very strong role in how we invest, how we react and can be our worst enemy even at the best of times.

Despite being told things rather directly, as investors with busy lives, we do have a tendency to forget. This is often then amplified by over focusing on the potential negative scenarios. Not that such tactics do not have worth, its more that it tends to drain our energy and lead to those emotions running away once more.

Right now, AVCT is progressing towards its prototype with two companies on two tests. That in itself should offer some comfort, as it shares the load somewhat. That's not to say the BAMS test is an equal partner in all of this, more that the current valuations that we are witnessing, can be strongly supported if not added to, by success on either test.

To move one stage further, at the results presentation from 6th May, CEO Alastair Smith stated that ;

“We have developed a number of lateral flow tests (LFT) ourselves and so have partners. Some of those evaluations that we talked about being successfully completed, are exactly for LFTs”

“We can have a great deal of confidence that LFTs using Affimers can be developed. So I think we should be confident that the test will be developed”

"Historically, the tests we have developed with Affimers have been very good, in terms of sensitivity and specificity. So we expect that to be the case here as well.”

3 really strong statements as to what should be expected of the tests, when they are validated and CE marked.

However, it is plain to see that concern remains that the actual outcome will be below expectations and the market potentially disappointed. At this point it is important to appreciate that high sensitivity and/or specificity, does not have to mean 99.9%. The perceived competition isn't delivering those sorts of numbers, so to expect that from AVCT is perhaps a little too much.

The key is to be sufficient good enough to lead the market and be accurate enough to warrant large scale roll out.

Now this is where it gets interesting for me because the actions of the AVCT team, already point towards a belief that that level of quality is there.

A great example of this is the wording used by Mr Smith in that presentation, where he says ;

"we'll be putting in place other test strip manufacturing partners and OEM partners because the production capacity, considering what we expect the demand for this test to be, cannot be supported with a single partner.”

One doesn't say such things so early in then process, if sufficient data does not yet to exist to back it up.

He went on to say ;

“Over the last 10 days or so, we have been manufacturing reasonably large quantities of the Affimers that we’ve generated, in order to provide quantities to Cytiva and the others that I’ve mentioned and those will be shipped in the next few days”