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Apologies terrible english.

"I think whats perhaps being overlooked here is just how big a deal this AVCT test will be if it is able to be put to significant use for mass screening."

I think whats perhaps being overlooked here is just how big a deal this AVCT test will be if it hits its able to be put to significant use for mass screening.

This isn't about shopping around or concerns over not being able to get manufacturers interested. This is about getting enough scale, getting enough manufacturers. We could add all of the reputable UK based manufacturers together and they wouldn't even get close to satisfying Europe. They might not even be able to satisfy the UK alone if as recent reports have stated, the desire is to test the NHS, at schools, Unis and airports.

What we are likely to see is a scaling up of manufacture both individually and in wider jurisdictions. Its potentially a massive massive project and with it a substantial logistical headache. Hence why getting the UK validation and manufacturing in place makes sense. They can't do everything at once.

So as with GDR, achieve CE mark for Europe, focus on those sales and then ensure that the data is in place for regulatory approval applications such as FDA, WHO EUA and then individual country specific.

The clinical validation of this test and confirmation of suitability for mass screening, is the final key development to starting to access all of the above.

From the same 7th May webinar (c. 43 mins 45s)

"whilst Cytiva is obviously a great partner with real scale to have on board, we will be putting in place other test strip manufacturing partners and OEM partners because the production capacity, considering what we expect the demand for this rapid antigen test to be, cannot be supported with a single partner."

Any idea that Cytive can't or won't want to manufacturer these test strips is for highly unlikely.

https://webcasting.brrmedia.co.uk/broadcast/5e985bc231da814c9fc6a477

Whilst everyone is entitled to their opinion and may share ti as often as they wish, comments about "major slippage" are for me poorly informed. I do feel for those that perhaps have less time to research their topic and may for some inexplicable reason, believe such theories and so I will offer you this ;

AVCT 7th May Webinar c. 45 mins 30s.

"AVCT aims to have validated and CE marked the test for professional and consumer use as soon as possible in the summer"

Dr Smith added ;

"So the middle of summer is when we are aiming for"

The middle of summer is around about the end of the 1st week of August (summer being 21st June to 21st Sept).

At the time, this was based on the fact that "Cytiva aims to develop prototypes in a few weeks."

The Affimers were shipped to Cytiva on 11th May, at which point the same "few weeks" message was conveyed.

That places the prototypes at around about early 1st week of June. In reality Cytiva took a further 3 weeks to develop working prototypes. (24th June).

So one can assume the dates are running approximately 3 weeks later than planned. In very simple terms that would place the "validated and CE marked" test at c. end of August.

If that information leads contributors to believe that the process has had "major slippage" then that is their prerogative. What I see is a very complex process with an already short timeline, that has required additional time for what is the most important part of its journey, the part where it actually has to be made to work and it has been achieved. 3 additional weeks to achieve that are well worth it and 3 weeks in this current Covid world is nothing.

Like I said earlier it is of no concern to me but I just don't appreciate such flippant remarks being thrown around without a thorough enough review of the facts as they stand.

https://webcasting.brrmedia.co.uk/broadcast/5e985bc231da814c9fc6a477

"Kate Bingham, chair of govt vaccine taskforce, is "optimistic" a vaccine will be found but warns that "in the near term we may have to satisfy ourselves with a vaccine that reduces the severity of the disease""

"Kate Bingham tells the science and tech committee a vaccine could come early next year (excluding trials done at Oxford University). Sarah Gilbert, of Oxford Uni, says it could come sooner, depending on efficacy trials."

"Tory chairman Greg Clark asks whether the UK should prepare for the winter without a vaccine."

"Prof John Bell, of Oxford Uni, says his strong advice would be "prepare for the worst" scenario."

I have aged family that are restricted by this virus and so I likely won't see them for more than a year, if not more. So things like proposed vaccine timescales being potentially delayed, should never be rejoiced. However, reality is reality. The vaccine timescale is extremely ambitious and so has more chance of being extended than not.

"prepare for the worst" scenario." means a substantial amount of testing throughout the Winter and likely beyond. There is no avoiding it.

https://twitter.com/LizzyBuchan/status/1278323027302854658?s=20

Investors who threw the kitchen sink at BMN in Sept 2016 had "achieved precisely nothing a few months later" because the share price didn't really move for the rest of that year.

Jump forward 2 years and those same investors were sitting on 3,500% gains. The same games were played back then too. The same criticisms of having the gall to actually hold a stock and believe in its story, also played out.

It did not matter in the end.

These days everything seems to be about not just wanting it tomorrow but yesterday instead. Those wants can destroy excellent outcomes gained through patience, time and belief.

When the search for negative scenarios begin to reach out as far as partners shafting their customer in order to better their own fictitious products, then as an investor, I know i am on to a winner.

In my opinion, the only headaches stopping AVCT from selling a truly substantial number of these tests is the clinical performance and their ability to ramp up production to meet demand because demand is now a given. The second headache is a very nice one to have. Yes we can talk about US manufacturing and FDA approvals but the reality is all of that will fall into place for a high performing AVCT test because the demand in society will drive it.

We've seen what the US has done with the available remdesivir. That demonstrates the demand for solutions to Covid that open up areas of the economy, currently shut down or struggling to make the numbers work.

As for the performance, it is abundantly clear that the AVCT Affimers are highly specific, so in terms of the minimum requirements that AVCT have set themselves, they being 95% specificity and 90% sensitivity, they have every going for them to achieve the specificity.

However, in their very informative diagnostic test performance video, that was freely given at a time of the company's choice, Dr Smith stated ;

"we are aiming for a high performing test with both the lateral flow test. . . and (while we are at it) the laboratory test with Adeptrix."

If so then the indication from the video, is they are aiming for a test in the region of 98% specificity and 95% sensitivity.

When AVCT released that video, they knew fine well that they were releasing their "positive initial performance data" for their lateral flow test, the very next day.

All of which screams very loud that the test is demonstrating enough signs that it can hit their performance parameters with a healthy margin of wriggle room, between the high performance tabled and the minimum self imposed mass screening target.

Investors can analyse that to death and fill their time with negative connotations as much as they wish, but the indicators are very strongly saying, that the test will be suitable for mass screening.

Yes it needs to be confirmed. Yes the journey that is the process still has to be walked but what is certain is that the demand will be there, so it is about time and maximising performance, which will itself opens up even more avenues for sales, as those areas of business where litigation may play a part, become more secure. However, that isn't going to stop those very substantial sales taking place, it is purely the icing on the top of the cake.

Its understandably difficult to contemplate what AVCT are on their way to achieving here but that doesn't make it any less real.

@Magsy18 There's an awful lot of negativity wrapped up in that post and much of its dependent on maybes.

You are more than entitled to think that way if you wish.

For me, the idea that lower middle income countries are somehow organised enough to "put in processes to mitigate against any shortcomings of existing products," or that such measures actually exist, is for me simply not possible.

What measures can a government put in place to counter tests that aren't sensitive enough, other than test the person again? It either works or does not. Its either a good product or it isn't.

Having a foot in the door does not guarantee anyone a full belly. Taking India as the example, despite their current uncontrolled outbreak and their cases essentially being as high as they have ever been, they are keen to reduce the costs of their testing bill. Reason. They cannot afford it.

So if new products come along that are cheaper and remove the number of operations, or prevent doubling up tests, or can be stored and transported far easier, or are more sensitive, then the idea that governments won't purchase them because they have a deal in place, is for me absurd.

NCYT can increase its product 10 fold and it still wouldn't be able to satisfy the demand that exists worldwide, which is the main point here. GDR don't need to push other players out to succeed, they just need time to demonstrate the value proposition of their test.

Once established, the test will speak for itself and then they will have the chance to dislodge other test suppliers, who don't necessarily need to be AIM listed. There a great many very poor tests still being used out there in the world and GDR doesn't need to dislodge very many, before Cytiva would be putting on more shifts.

I appreciate your cautiousness and respect your opinion but I don't agree.

@PL75 I appreciate the compliment, thank you.

To be clear. Not being first to market has nothing to do with the future success of the GDR product. Two reasons.

1. Nearly all low to middle income countries are failing to test at a level that is required to reduce their covid cases and instigate track and trace, if they indeed have the infrastructure and will power to do so.

2. The second phase of covid testing will be about quality, cost effectiveness and ease of use, which in turn will reduce costs.

The GDR test is more than strong enough to carve out new opportunities where testing is lacking and displace other tests, where the process is more laborious and so the additional costs of use, are higher.

Just because the GDR test costs 8-10 pounds, does not mean that is the true total cost to the user.

Africa example.

Nigeria. Population = 205m
First Covid case reported = 21st March.
Current cases per day = c. 600

https://www.worldometers.info/coronavirus/country/nigeria/

Generally speaking Nigeria has moved from finding c. 300 cases per day between early May and early June to the above c. 600 cases, between 9th June and today.

That graph is not consistent with a country that is managing to control its outbreak, it is consistent with a country that has increased it testing slightly and so is finding more cases. However, the idea that Covid somehow behaves itself better in African countries such as NIgeria, is simply implausible.

The number of cases being found in nations such as this is completely dependent on the level of testing being conducted. At 205m population, Nigerai has a problem at just 600 new cases confirmed a day. So if more testing capacity is on offer that can be implemented for less cost, they are highly likely going to purchase it.

Another shining example of this is India at 1.38BN population and yet is still miraculously only finding c. 18,000 new cases, some 3 months after their outbreak started, when they are only testing c. 140,000 per day. It is wholly inadequate and it is being driven by both the cost of testing and capacity.

It is a pattern repeating itself across the world. The nations with the biggest recorded Covid cases per day rigth now (US aside), are not capturing anywhere near as many cases as the European nations did during their largest case numbers. So the reality is far removed from what is reported, which means the opportunity for the likes of GDR and AVCT, even NCYT, is substantial to say the least.

Agreed. Hence my point about not posting here anymore.

My view. Achieve FDA and WHO EUA plus India and GDR will have more than enough to be going at for the foreseeable future because it will give them most of Africa as well.

I would like to see some of the Arab countries pushed for because they struggling to control their outbreaks and are wealthy nations. However, I will be delighted when the above 3 with Europe, are all in place.

@Magsy18 Sorry to be blunt but does it really matter? Will it have any affect on the longevity of this company or its success? The important thing is that the applications have been made and the company is moving forward with their products and in particular, front end, the Covid PCR test.

Investing is about establishing as many facts as possible and making percentage calls on what we have learnt, good or bad, for ourselves. On AIM that mantra is magnified several times over.

It is always good to hear other points of view and perhaps learn something. It is foolish to think everyone is pulling in the same direction. GDR and AVCT are both being played right now, not because they don't have bright futures but because there is an opportunity to do so, helped along by telegraphed future news items.

Once those windows close, so will sentiment change and the fundamentals, such as the fact these approvals are in play and that sales are expected, will come to the fore once more. That's why it will be better for longer term investors when the volatility dies down and more sustained progress can witnessed.

In the 12th June presentation it was confirmed that GDR have already applied for FDA, WHO EUA and India country specific regulatory approval.

It is the easiest job in the world to label someone on these BBs. It is one of the main reasons why I simply don't bother posting here anymore. many hours of research can be shared but dismissed by such drivel and then quickly pushed out of sight.

On 22nd April, GDR signed their agreement with Cytiva and stated "we are working very aggressively and plan to have product available in the next five weeks."

On 1st May, GDR announced their pilot manufacturing milestone and stated "the overall project plan currently remains on track and the company is targeting CE marking in approximately 3 weeks' time."

GDR achieved CE Mark approval on 22nd May. That was exactly 3 weeks later and 4 weeks and 1 day of their indicated 5 week deadline.

They then conducted a presentation with Q&A direct from retail shareholders, on 12th June and asserted there that the first sales update would be early July.

What he also clearly stated was that "we are only a fortnight in (post CE Mark), so we're not in a position of reporting sales orders. I think most people would appreciate that."

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

"End users have to assure themselves that it works and they have to assure themselves that it is safe. They don't do that just because you say it is." So it needs to be put through its paces but personally I think"

"Its amazing what we have been able to deliver in such a short period of time. I don't see any reason why this shouldn't translate into a significant business for us."

"I had already communicated that we expected orders in June. So as a minimum we will do an update early July."

Obviously if anything price sensitive happens before that, we would update the market as well."

What on earth more did they need to do in that time period, to satisfy the "good communication" and to prove that they can deliver what they have told the market they can.

A high performance PCR test with competitive advantage to its peers, delivered in just 9 weeks, is extraordinarily good work and was the hardest part of all this process, including sales.

Many people are. . .

@saint-tropez unfortunately what is happening in Leicester is going to keep happening the world wide. Its what happened in Beijing, whats happening in Victoria Australia, whats taking place in the area around the meat plant, in North Rhine-Westphalia, Germany.

These outbreaks are unavoidable, as economies start to relax social distancing measures, people mingle and start to lose their focus on protecting themselves, which is clearly happening. See Liverpool football club, Brixton street parties, Bournemouth beach etc etc. . .

People aren't educated enough, they are frustrated by being locked up, they are selfish and the lower the case numbers go, the more they will forget.

And all of that is in countries that can implement significant testing. That can afford to lock down in the first place. That can track and trace well and have the funds to do so.

Lower to middle income countries have no chance.

my people are having a psychologically block on covid because they cannot believe/contemplate that something so disruptive could be around so long. So they block it out or seek refuge in UK cases being under 1,000 (tested) or a vaccine that is promised to make it all go away. Well to date that isn't going to happen and right now we are seeing a multitude of examples, that demonstrate just that. The more society opens up the more Covid can succeed.

Testing will be around for a very long time to come.

@andymlloyd with all due respect, you are demonstrating an impatience for results.

I could name several very successful investments in stocks that infuriated investors with their lack of PR or periodic updates.

In the end, it comes down to what the business achieves on the ground, not how often shareholders are updated., which requires patience. I genuinely mean no offence by this, all investors are entitled to feel how they feel about their investments, I am merely offering my opinion to your response.

GDR are not renowned for regular updates but then they never had a such an active test before with so many regulatory and country roll outs required. I would therefore trust that they would update more regularly but as I say, it will be the actual work on the ground that matter most.

@Swerves If i may, what CEO David Budd actually said is that the end of June is company year end, which means they will be particularly busy with work associated with that task. Therefore, he expected an update would be issued to the market early July.

Last year the company did exactly the same thing on 9th July.

@andymlloyd may I ask, why does something gigantuan need to take place, in order for £2 to be achieved? Why does £2 need to be achieved in a day or a week?

The initial phase of extreme price rises in covid related stocks, has led to a belief that these stocks should always act in that manner. The reality shouldn't be that way. GDR is very much capable of returning to that sort of valuation but it would be far healthier if it did, on far stronger foundations over a longer period of time. The volatility is no good for anyone and puts off investors seeking stable investments who would deliver support to the SP.

It may not be as exciting for some but in my opinion, the most successful investing is generally achieved in that manner. Whatever the short term trends or manipulations of this stock, its performance in its markets are what will ring most true in the end and that will take time to achieve. What's key is that the Covid testing market isn't going away for some time, so the opportunity is a really good one for GDR, as a front end revenue generator, ahead of their AIHL test roll out.

In my opinion.

@O&W that is a perceived risk be it a worthy one. They need to prove themselves. However, whats more important is they have a product that has competitive advantages in a market that is in short supply. The HCV test has struggled to achieve sales but the two stories in terms of investment and demand, cannot be compared.

To fully exploit their target markets they need further regulatory approvals and there they have demonstrated previous successes.

RNS 4th Feb
"Indian regulatory approval for the HCV ID kit received in December 2019, bringing the total number of registered countries to 14"

4th May
"Genedrive® HCV-ID test receives WHO Prequalification."

So they have form be it that the HCV registrations took longer than anticipated. With Covid they shouldn't have the same issues because as I said, they are tackling these registrations at a time when higher quality, easier to use Covid testing is in high demand.

Right now HCV test sales have clearly been interrupted by the more pressing matter of Covid. Countries of wealth have delayed a great deal of 'non-essential' healthcare investment/operations. So the idea that lower middle income countries are fairing any better is for me highly likely.

For me, given sufficient time to breathe, this test will do very well and as the year develops, the prospect of the AIHL test completing its trials at Liverpool and Manchester, and achieving first sales, becomes ever more relevant here.

Good morning,

I see little benefit in building up expectations around the first sales RNS, it usually only leads to disappointment.

What is key with GDR is that their product has competitive advantage and is entering the market at a very good time for covid testing. This is particularly relevant because they are working towards both FDA and WHO Emergency Use approval. The second of which will give them far wider access to Africa and other lower middle income countries, which are long term markets for Covid testing because of their inability to control the spread, their lack of testing capacity and the likely longer period any successful vaccines, will require in order to be rolled out there. Personally, I believe GDR have a very good run at lower middle income countries for at least the next 12-18 months, with ongoing sales after that at a lower level, be they still potentially substantial.

Looking at NCYT, post CE Mark approval, they required c. 38 days to complete their FDA approval and c. 50 days to achieve WHO approval. GDR are currently at day 39.

No two businesses are the same but it gives a rough idea of what can be achieved and potentially how close these approvals are.

Given the product has only been on the market c. 5 weeks, as an investor, I don't expect block buster numbers in the first update. What I am looking for is market penetration and the foundations for bigger longer term sales, with the bonus being the signs that direct sales are there because that means greater revenue share.

All just my opinion.