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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.

@Pl75 As is your prerogative and if nothing else it is worthwhile debate.

I have read around the government trial and whilst it does mention AVCT in the initial news release from the UK government, it does not mean that the AVCT test in involved. For me its was just too early in the AVCT process, for that to be true.

What it does is certainly shine a light on the use of saliva in home based testing. It also for me gives clear indication of interest and support that AVCT would get, if their test proves to be suitable for such roll out.

So yes it is always possible that things could be fast tracked even more than they have been already. This is indeed supported by the UK government's stresses around their commitment to opening up schools in September, Unis on October and of course, the public's perception that they have previously failed on Covid.

However, for me, until we hear otherwise, I wish to play it safe and accept that in field testing will be required. This may run in parallel to clinical validation. Who knows? I would think AVCT and their partners are very clear on what they need to do to achieve a UK government sign off and I am sure every effort is being applied to complete these regulatory requirements as soon as possible.

I have said several times before, that the only true hurdles for a major success for AVCT on their LFT, is performance and demand.

The demand for me this Winter is absolutely clear and not just in the UK, be it that it is a potentially really good customer. The performance for me will be signaled once those manufacturers are signed up.

I have no doubt whatsoever that UK government will be a large customer for AVCT. For all the proposed competition, which itself is very limited, no other UK company is currently bringing such a product to market in the UK.

The question will be at what point the UK commits to an order that will likely be concluded only when the AVCT test has been tested in the field. That's not clinically validated but one step further on.

I would think that all markets will be valid and demand will be robust, so it'll be a nice headache for AVCT and its manufacturers to have.

Sona reported on 22nd May, so approx 6 weeks after they commenced optimisation ;

"Sona has received expressions of interest for tens of millions of its a COVID-19 rapid detection, point-of-care, antigen test and has secured non-binding letters of intent for 4.7 million of its tests, subject to test performance parameters and pricing."

If nothing else, the world of AIM and all the businesses connected to it and through the investors on it, has very much heard of AVCT and what it is working towards bringing to market.

Then add in the Boohoo deal PR.

The idea that there hasn't been a lot of PR to date is for me incorrect.

@PL75 Appreciated but I disagree.

The idea that the Medusa19 team, which I expect will have the same aggressive drive to it that Boohoo had from the start, is simply dedicating considerable sums of money and time, to set up a distribution business that has just 1 product and not employing its networks to drum up business, is for me highly unlikely.

I don't expect AVCT to be anything but professional on this and only talk about orders when they deem it appropriate to do so. However, post optimisation and manufacturing start up, be it for validation batches to begin with, is the point at which that trigger can be pressed. Regulatory approval is a process that has to be worked through but it is just that, a process.

I tend to lean towards AVCT holding back longer than many others would but that doesn't mean that the orders aren't there.

If Medusa 19 weren't in the picture then I would be less confident but for all their awkward press of late, these guys know how to drum up business and looking at the appointments to date, they aren't messing around.

One query I have in my head is when will AVCT be brave enough to start talking about orders.

Sona announced their first pre-orders of 1.25m at the point they stated they had moved from prototype to optimisation stage.

Given what we now know about the Sona test and the fact it isn't advertised for mass screening, plus the fact they don't have a Medusa19 working in parallel to their own efforts, I find it extremely difficult to conclude that order interest isn't already there.

The question is when will AVCT be brave enough to talk about it?

Apologies was interrupted during that post.

I say this not because I believe there is a chance that the test won't come to market, not at all. I am referring merely to the market's perception, which I must say is demonstrating a far less fickle attitude of late, than I assumed would be the case.

I think some investors are going to drive themselves to distraction with all the guessing games around RNS timings etc.

My view.

Firstly, if progress on the AVCT tests is going to be announced then it will be here because the tests are owned by AVCT. There is no obligation as far as I understand, for Danaher to be tied into any announcement whatsoever. This is demonstrated through the fact that Sona updates, have not been published by them either.

Secondly, the next update should be the disclosure that optimisation is complete and that tech transfer to the agreed manufacturing partners has begun. In doing so we should find out how many partners there are and what their expected timelines and processes are for bringing these tests through to regulatory approval.

For me this is the most critical inflection point because it will signal that the tests are effectively there and will reach market. What it does not mean is that specificity or sensitivity will be talked about. There may be some indications on performance but the actual figures, be it they will have their own, highly likely will not be mentioned because only the clinical validations can determine that. Therefore, it would highly likely be deemed conjecture by the nomad and therefore not allowed.

Sona followed the exact same route and actually announced their own previous results on sens/spec with the independent results on 2nd July.

However, as I say, it will be the actions of employing the partners and who they are, that will speak very loudly about the test coming to market. I saz this not because there is a chance that the test won~t

Dr Smith is a straight talker who for me doesn't play the usual AIM game of messing shareholders about. He tries his level best to educate and keep investors informed because he appreciates that a great many investors, do not understand the complexities of what they are now involved in. That should be recognised and appreciated and not whined about.

He and his team are managing a difficult process at speeds not normally seen that needs to be respected. A few days here or there are not key here. What's key is that a test suitable for the market it is intended for, is produced. The stronger that product is, the less we all have to be concerned about sales and the competition that is assumed capable of undermining it.

The next set of updates are a stepping stone in a process that doesn't finish for a good few weeks yet, so some stamina is required or some will have a very difficult and long Summer.