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@gmcc Thank you, great detective work. As per my post yesterday, look when Richard Hughes became a director of Medusa19.

22nd April, the day AVCT announced their collaboration with Cytiva.

Funny how a company can be founded for a product that was deemed to not even be in the development phase, which in turn compounds the decision date for when they went public with the deal (20th May), just 9 days after the Affimers were shipped over to Cytiva.

Important to place this in the context of understanding that AVCT have successfully produced LFTs with Affimers, for previous customers in their diagnostic division. So this isn't their first time.

More importantly all of the above wad conducted so early on a product that Medusa19 will be selling direct to consumers, which given the concerns raised by the likes of MHRA, needs to be a high performing and easy to use test.

Interesting stuff for sure.

Continuing the distributors themed thread for those that find it useful.

Here is what the June presentation said ;
"Avacta has put in place a distribution partner for the direct-to-consumer market (Medusa19) and will put in place additional distribution partners for the healthcare professional/work-force testing markets, as well as OEM partnerships in order to maximise the commercial opportunity."

So as well as OEM partnerships, which itself could be dissected considerably, we can expect further distribution partners who won't be able to sell direct to consumers.

Intriguing beyond belief because it is clear that AVCT knew the wider strategy when they signed Medusa19 up. Hence why Medusa19 only got "non-exclusive rights to supply the tests to businesses for workforce testing."

Who is on that list AVCT?

Note also that the 20th May RNS states a belief that ;
"There will also be an ongoing need for several years for this type of testing as the disease recurs."

@Milcait FRom the Medusa19 website ;

"Medusa19 has the exclusive distribution rights to directly deliver to consumers a saliva based rapid test, currently under development by Avacta Group Plc, for the COVID-19 antigen, subject to regulatory approval. As such, its immediate priority is to invest in the necessary functions that will enable Avacta’s test to be rapidly and globally deployed once it becomes available."

Right now, it is AVCT who are very close to announcing the manufacturers and not Medusa19. There has to date been no indication that Medusa19 would fulfill such a role. That's as much as we know right now.

"Longer-term, the Group’s objective is to entrench itself within the global medical supply chain, serving businesses and consumers worldwide with a range of tests and solutions that identify a variety of conditions, supporting health, well-being and business continuity throughout the globe."

Then we have the above longer term goal, which as I say, if it is indeed to fed at least in part, by AVCT "in-house" products, then those products shouldn't be too far away from being begun to be spoken about.

From the placement RNS dated 4th June ;
"Expansion of in-house diagnostics product development capabilities including facilities, capital equipment; scientific, commercial and senior leadership teams"

It doesn't say it is specifically for Covid.

Furthermore, the same update goes on to state ;
"This substantial fundraising allows us to. . . scale-up the diagnostics business to expand the Affimer® diagnostic products pipeline"

This can of course be referring to more diagnostic tests being developed for partner distribution deals, as has been carried out to date. However, as Dr Smith states in the 2019 Annual Report Q&A ;

"The principal reason for this is that the process of a partner committing their own resources to developing an Affimer-based product so that they can evaluate its performance before committing to a commercial licence is slow"

"It is the time taken by the partner to develop and evaluate the Affimers, when other business activities may well take priority, that is rate determining."

"This is why we have taken the step of developing Affimer diagnostic assays ourselves, because we can prioritise the resources to do this more quickly than a partner and reduce the time to get to a licensing deal."

The next natural step is to focus on DTC tests, such as the Covid test, which itself when successful will be a demonstration of the methodology because it is the pioneering product that allows manufacturing partnerships and distribution deals to be formed and put to the test. New products can therefore 'simply' follow the same trail.

Difficult to fully appreciate at the moment but potentially a really big opportunity for AVCT and their new partners.

@Milcait A good point which can only truly be answered through company developments themselves.

Of additional interest to myself is the fact that these directors have joined a start up that to date only has 1 product, which is still in development. Medusa19 may have other partnership announcements pending but to date they are still quiet on this and their website is clear, their product base to date is the AVCT rapid antigen test only.

For me this is yet another example of the confidence that AVCT have in their ability to deliver a product that is suitable for DTC sales because whilst this deal was itself announced early (20th May), the MD is reported to have been in place since April.

In addition, we have highly successful and well publicized entrepreneurs from Boohoo (recent newspaper accusations noted) who have gone public very early on this deal. Again another sign of the confidence that AVCT have demonstrated to these investors.

There could/should of course be a lot of work in promoting and rolling out a product that they have "exclusive distribution agreement with Medusa19 for the supply of the COVID-19 rapid test direct to consumers globally." So lots to keep them busy and as a side note, plenty of reason to believe that they will be very active in country specific authorisations because it is in their interest. Add to this the fact that they must be putting a lot of effort into advanced sales and I am sure that through Boohoo, this net can be cast far wider than AVCT would currently be able to achieve.

However, there is only so long that such "significant investment that Medusa19" can be justified before new products are required to expand what is a attempt to corner/develop/expand the DTC market in diagnostics.

AVCT 20th May RNS ;
"We look forward to working with Alastair and his team and to distributing other Avacta products as they become available in due course.”

One does not say other products unless there is an agreement or basis for such a relationship and there are clearly signposted products in development. These processes after all are not normally so short.

I recognise the negative press of late over Boohoo but I remain open minded about the overall influence that this deal can deliver to AVCT because it looks to be clear that AVCT are expanding their diagnostic business not just to meet the Covid test demands but to expand upon the DTC market opportunity, an opportunity that Dr Smith is clear on, in that it delivers revenue from the moment the first test is sold.

All of which, much like the Pre-cision and TMAC platforms, will be further strengthened by every pound that the Covid tests generate for AVCT.

Agreed but for me PCR testing will highly likely also be employed to double check the positives that are generated from tests such as AVCTs.

That's where the sensitivity really kicks in as a higher performing tests will widen the circle of customers and include more and more of those that are themselves sensitive to customer complaint/litigation.

That said, most companies that are running at reduced capacity or not at all, such as cruise ships, should be happy to invest in localised PCR testing facilities, to reduce these outcomes because it is a far better position than they have without it.

It'll take time for tests such as AVCTs to bed in and agree regulatory approvals in sufficient number of jurisdictions but the demand and willingness, for me, will clearly be there.

Its a golden ticket to doing things better but for far less cost.

@Canute40 I don't ever like saying troll but I appreciate your point and I am as much to blame as anyone.

Really interesting update from AVCT, be it that it merely confirmed the suspicion. Tests such as AVCT will be in high demand as countries seek to reduce their PCR test costs and lower the burden on their health care systems.

Back logs in other procedures being the key focus.

@alwayswinning You can attempt to twist that tweet as much as you like but if investors read the piece properly, then they will see that it is a very big positive for AVCT and the size of the market that is to come for their LFT.

As suspected, the PCR market will be toned down and tests such as AVCT will take over.

Terribly confusing last post, I apologise

@alwayswinning

With all due respect you are attempting to employ a test that is considerably further behind in its development process, as a means to demonstrate that AVCT is somehow behind "the competition" and so is losing out.

In doing so, you are inadvertently ignoring the fact that this very test, backed by 3M, demonstrates that perceived bigger players out there, believe that a market for millions of tests will be there for them, when it is finally ready. Even if that is in the fall.

If anything you have just delivered demonstrated that AVCT are ahead and that the market demand will be there when they arrive.

@alwayswinning

With all due respect you are attempting to employ a test that is considerably further behind in its development process, as a means to demonstrate that AVCT is somehow behind "the competition" and so is losing out.

In doing so, you are inadvertently ignoring the fact that this very test, backed by 3M, demonstrates that perceived bigger players out there, believe that a market for millions of tests will be there for them, when it is finally ready. Even if that is in the fall.

If anything you have just delivered demonstrated that AVCT are ahead and that the market demand will be there when they arrive.

So which is it? No market or the competuiti

fact that 3M in mid July, believe there is an opportunity in developing a pregnancy style test

Cytiva's own website states the Avacta collaboration to be "Affimer-based point-of-care rapid screening test."

Klaus says 95% sensitivity is needed for such a test to be suitable for that job.

@Wiggly You are absolutely correct and we can take that one step further and quote Klaus Hochleitner from the Labroots webinar ;

"We have to develop antigen tests that have a sensitivity that is much better than 95%, as it will not be useful for a screening test"

Since then they have achieved that with the other participant in that webinar, Sona Nanotech.

So when he says "very encouraged by the initial data" is then going to go and let himself down, by not achieving what he believes to be essentially his own minimum requirement?

As we discovered in the IG interview, this is a joint development between AVCT and Cytiva, with costs shared. Cytiva aren't just feeding a customer here.

Dare we dream. . .

Apologies, that should have read ;

"given that a "high performance test" was demonstrated as c. 95% sensitivity/ 98% specificity."

@Chartmy I fully appreciate that there will continue to be a level of anxiety for a good many investors, until such time the company has confirmed the clinical performance of the test(s).

However, I would once again remind everyone of what Dr Smith said in the 23rd June diagnostic test performance video, a video that was released 1 day prior to the working prototype announcement being released.

The latest MHRA guidance employed in the video was stated as being 80% sensitivity and 95% specificity. However Dr Smith stated that ;

"we are aiming to have a much higher performing test than that"

and that in AVCT's view ;

"the minimum hurdles for a rapid antigen test for use in the general population, are a sensitivity of +90% and a specificity of +95%"

But that further to this "we are aiming for a high performance test with both the LFT. . . and the laboratory based test (BAMS)"

Given how pragmatic Dr Smith is and that AVCT did not need to publish that video and the fact that they did it, one day prior to confirming that the lFT working prototype was working, the odds say the follwowing ;

1. The test is highly likely going to come to market.
2. It is highly likely going to beat the MHRA minimum requirements.
3. It is highly likely going to beat AVCT own minimum hurdles.
4. It has a very good chance of pushing even higher than this, given that a "high performance test" was demonstrated as c. 95% sensitivity/specificity.

Can I say that they will hit any of the above actions for certain? No. Hence why I say highly likely. Things can always go wrong.

However, the evidence is heavily hinting at a working prototype that as of 23rd June (day of the video release), was demonstrating sufficient performance criteria, as measured by both AVCT and Cytiva, that said video could be released and said above things could be said.

All of which is hammered home by the IG interview where Dr Smith talks about "expecting to sign up manufacturers very very soon." A statement made 8 days into the optimisation of the LFT.

That announcement must now be very close and its make up, the names, their production capacities, will go a long way to demonstrating what AVCT think about their test's performance.

Clinical studies will still be key but post optimisation and manufacturer sign up, the message will be very clear as to how marketable this LFT is going to be.

So yes lets please have that next update but the anxiety is very much focusing in on the smaller of the percentages here.

Here's the interview with SKIN's CEO.

Aiming to target the cruise industry and then talk of employing AVCT LFTs to isolate persons on the ship. Yet more confidence being shown in the AVCT LFT test.

Furthermore, the consumable devices have a shelf life of 1 month so the revenue is recurring on a shared revenue model basis. Aiming for prototypes being ready in Sept.

Most importantly the Modern Water 3,000 units comment from this morning's AVCT RNS, is just that and not the full market. So options for sewage points and the opportunity looks to be world wide.

We require more information on this but it does indeed have potential to be a significant revenue stream than perhaps first thought.

In addition, it once again puts the AVCT Affimers on the map and future usage outside Covid, for other diseases.

https://twitter.com/AndrewScottTV/status/1282619172757929984?s=20

For all of the nonsense and mud slinging that AVCT holders have to take, (much of which is designed to create anxiety and stress, in order to separate us from our shareholding) there is nothing wrong with being genuinely excited about what should now unfold here.

AVCT is literally days away from completing the optimisation of its LFT and signing up multiple manufacturers for it.

Yes the clinical validation is key to the exact performance of the test but the above stage will for me, clearly confirm that the LFT is coming to market.

Said LFT is going to be in high demand because tests like it, if nothing else, have the ability to remove the need for a substantial amount of the current PCR testing capacity. That's what more cost effective easier to use tests do.

That said there is nothing in any thing the company has communicated to date, to say the test isn't going to happen. This is more about having the confirmation so that the mud slingers have one less thing to throw at shareholders.

Such sustained mud slinging allows doubt to creep in. It allows questions to be raised against things that are all but certain. That's what it is designed to do and it isn't going to go away anytime soon. So I would encourage those addicted to reading these BBs, to spend just as much time re-reading the information and videos released to date, over and over again, to maintain a level playing field and enable you to make measured decisions, rather than rushed and impulsive ones.

The mud slingers know how easily things the company said are forgotten. It is human nature. So arm yourself over and over again.

There are highly likely very few businesses worldwide, that are willing or indeed are able, to judge a new product's success, just 7 weeks after its launch and prior to it gaining regulatory approval in its key markets. Yet according to a good number of contributors here that judgement can very easily be made and indeed has been.

I wish them well but the real world doesn't operate like that, however much said persons wish to drive that message home.

@RBInvests As is your prerogative but your response only goes to further my conviction that you are oversimplifying the comparison, although you are not alone.

I have lost count as to how many times I see AVCT, GDR and NCYT all thrown into the same discussion, like they are similar or something. The only similarity is that they are involved in the covid pandemic market, to varying degrees.

I will however say it one last time, GDR is aiming for a segment of the market that to date, has barely been accessed and in part, cannot be properly accessed by NCYT, however many sales they confirm to the market.

@samolly2 I appreciate that and I sympathise greatly with those that are heavily under water on their investments here but simply making things up like "so they had CE approval and were expecting g significant sales in june," only services those that would wish to see GDR fail.

For the record, I am not gutted.

Covid testing is a far longer term play than many see fit to accept. The target markets that GDR are aiming for, will likely be the longest term markets for Covid testing, for those tests that are best equipped for their markets and provide competitive advantages.

People go on about NCYT as if its a 2 horse race. GDR don't need to replace what NCYT is doing, they need to replace the large percentage of tests that simply don't do their prescribed job. That unfortunately takes time but this market and the majority of this BB, simply don't want to give the GDR team time to execute. This is based on a ticking timer that in in most people's heads only.

The current Oxford/Astra Zenica vaccine trial that is being conducted in South Africa, is required to confirm its suitability for lower/middle income countries. The lead scientist has stated that when everything goes well, the vaccine wold be available to the S.A. market by Sept/Oct 2021. That's the beginning of roll out. That's not Africa, that's S.A.

That assumes that this first trial vaccine manages to provide 70% herd immunity. The average success rate of the influenza vaccine in the last 10 years is 50%. 50% doesn't cut it unfortunately.

There have been years when efficacy rate was as low as 10%. The first vaccine candidate has to have a heck of a lot go right for it and even then it highly likely won't be effectively distributed before 2022.

If successful then the vaccine comes to Europe first of all, closely followed by the US. It is still highly unlikely going to give herd immunity and so testing will still be required, longer term, be it at reduced levels. That's where better quality tests will earn their crust and when price sensitivity will likely finally kick in.

Realistically testing is not going away as long as Covid itself decides to stick around. So GDR has time and its target markets driven by its storage advantages, stand it in very good stead, post regulatory approvals.

RBInvest Why do you believe that NCYT is a direct competitor in all of GDRs target markets? Why is it you appear to believe that GDR cannot succeed simply because NCYT exist? Why is it a competition at all?

There is currently a world shortage of adequate testing capacity. That is before we begin to discuss quality testing. If NCYT has it all covered, then why does that shortage continue to exist?

Why is the NCYT Covid test not dominating the Indian market? highly ,likely because it cannot be stored at room temperature. Therefore, it is only suitable for roll out in areas where adequate refrigeration exists. It is generally not suitable for all other areas of which there are clearly many in India and many people live there.

From the now validated DIVOC site ;

"The Genedrive® 96 SARS-CoV-2 kit is stable at ambient temperatures which eliminates the need for cold
storage, making the test very practical for Indian markets. Given its ease of use and temperature stability, the kit can be employed in remote and rural areas."

The same applies for Africa, hence the GDR focus on those areas. Those areas require time to be exploited. They are generally slower at doing things. That cannot be helped.

The NCYT kit cannot do that. So its not about merely handing out contracts, its about what each particular contract's aim is and where it is situated.

@Magsy18 I will happily debate with you in a professional manner but to be clear, it is of little consequence to me if you buy or sell this share. There is a bigger picture going on here and the 12th June presentation, in my opinion, demonstrated a large opportunity for GDR, whose success is not based on sales in June or some assumption that any perceived failure to convert sales in June, means the CEO is untrustworthy or a liar.

Those notions are such nonsense, that I said as such the last time we debated. If you were able to review the + 5,000 posts that I have published here, over the last 7 years or so, you will see that I am always professional and courtious. This is business and should be conducted as such, at all times. There is much at stake for some and that should always be respected.

So when I said nonsense the other day, that really was about as far as I go with dis-courteousness and demonstrates how over focused the discussion is on these front end weeks and achievements.

What David Budd said at the start of the Q&A was "i've already communicated that we expected orders in June" and the slide 12 stated "anticipate first sales in June." So yes confidence from DB was high, well done him but I won't be shooting him if it fails to materialise because its only the first month of opportunity.

He then followed up with "as a minimum we will do an update in early July." No more no less.

Much more importantly, he also stated "the most critical thing. . . is the commercial agreements and revenue side of the high through put. Everybody I know is hanging on that, so I just ask everybody to have a bit of faith and confidence in what we are doing"

"we are working to establish lots of new channels and we are certainly not going to announce everything." At no point in the feed back question on expected news flow, did he says first sales would be communicated.

What he did also say in the Q&A is that about 60,000 tests were manufactured and sent out in the week after CE marking and "we've now got tests out into South Africa, Spain, Italy, Germany, India etc."

"The main feedback. . . people can't really believe how easy it is to use"

It is these sorts of comments from Mr Budd that are more of interest to me as an investor, than the exact timing of first sales, given the fact that demand is deemed to be longer term.

The test is in potential European customers hands and they are saying it is surprisingly easy to use. That points heavily towards sales, be it e cannot pinpoint June as the date. Is that critical? No. The sales taking place is what is critical.

"The process of purchasing a diagnostic is different to consumer products"

"End users have to assure themselves that it works. . . that it is safe. They don't do that just because you say it is"

You can by all means focus on that first sales itch but it isn't what is key here and given sufficient time, GDR for me will prove as much.