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@Magsy18 I'm done. You are entitled to believe what you see fit to. I have witnessed this sort of development many times and companies usually set a point in time to update the market on their progress to date. c. 6-7 weeks post product launch is not unreasonable and does not break any rules.

Many companies on many occasions have launched new products and not updated sales until their quarterly or even half year update. There is nothing wrong with doing so.

You clearly believe otherwise as you are entitled to do so. I wish you well with whatever investment choices you make with GDR.

@Magsy18 Agreed and that point was covered in my response to you at 14.37pm where i said ;

"Companies are expected to update the market when price sensitive information comes to light."

However, it is the company that decides this and would have to make a significant error to even gain the attention of AIM officials.

But as I have already pointed out and was stated by David Budd in the Q&A from the Vox presentation, the company has said it will update the market in early July and earlier if "price sensitive" information comes to light such as a distribution agreement that comes with a significant order (paraphrasing).

The fact it hasn't says there's no need to report outside of their telegraphed update. The fact there is a telegraphed update means that pretty much all sales can be pushed into said update. That's normal practice.

The reality is the vast majority of AIM companies employ the rules in their favour. They report as it suits them.

Just take a look at early oil plays. They can achieve significant increases in production over a short period of time but they rarely rush to tell the market until their regular update is due. Is that price sensitive? Yes it is. Does it make any difference? No it does not.

There is of course an expectation by investors to be regularly kept up to date by the company. many fail their investors on this.

GDR have stated when they will update and have conducted a presentation with Q&A, informing investors on price of product, production capacity, room for increases on capacity and regulatory approval progress. That is above and beyond what the AIM rules insist upon.

@Magsy18

You said ;

"we know that no orders/sales have been agreed as they would have been forced to update the market."

That's the point I was answering. If GDR are 'forced' then so is every other publicly traded company including my analogy Coca Cola because all are treated the same, huge firms and growth companies alike.

No company is forced to update. The initial sales will be stepping stone and an indicator of early traction in the markets that are available and have been investigated to date. No more.

Please show me where it is written in the AIM rules that all AIM companies must report early sales. Or where there is a distinction between established companies on AIM and growth companies. Please show me where the definition of a growth company is defined in the AIM rules.

The only true requirement for AIM companies is to report their 6 and 12 month accounts.

@Safy I'm sorry but this whole conversation is utter nonsense.

Nothing the company has said to date says they cannot sell the 'water.' It is those that are investors that have decided that they cannot sell the water because they don't have the patience to wait for the company to update them.

To be clear , the GDR product is gold standard. That's a quality ref. not a pricing ref. but being easier to implement, it should be cheaper on a full cost to implement basis.

You have a company that has told you that they will update the market in early July or sooner if they have significant news to share. That has told you that they have applied for the key approvals that open up the very markets they truly want to focus on (US, India and Africa).

Why is that not enough? What more do they have to do?

The beauty of all this is you are talking yourselves into being underwhelmed by any figures that are actually released because you are putting too much emphasis on the update and not letting the company deliver over a respectable priod of time.

@Magsy18 sorry but I am struggling to respect your view on this because its just nonsense.

If every company had to report every order it received, then Coca Cola would be likely be issuing several hundred/thousand RNSs a day. Companies are expected to update the market when price sensitive information comes to light (and even then many stretch it out for their own reporting means) or at timely intervals that are deemed by the company to be relevant and even that's not a requirement under AIM rules.

From my post here 2 days ago ;

"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."

GDR are now at day 41, so just 3 days different to NCYT. No two processes are the same and I will guarantee that both the FDA and WHO workloads on this, are far higher now than they were in April because more tests are coming to market.

I am not responding to your post in order to convince you, its more to help those that may actually think there is a legitimate argument to be had over these timelines and reporting periods. To be clear there really isn't .

This is business, its not a computer game or a casino, its investing for a longer period than just a few weeks post a product launch. I will leave this now but in all seriousness, the argument being put forward is deeply flawed and not healthy for long term investors or for those that may be sitting on paper losses right now. Give thee company some time because the key elements that are needed for a really good product performance, are there in abundance. They just need sufficient time to achieve it.

Link for those that wish to use it.

https://www.youtube.com/watch?v=HCiOLYEcWJ4

I would encourage anyone who has allowed themselves to be dragged down by only temploying this BB as the basis of their current mood towards GDR, to re-watch the 29th May proactive interview and the GDR Vox presentation.

A couple of key worthwhile points from the Proactive interview ;

David Budd ;
"truly because of its ease of transport, it does make the opportunity for use truly global."

Competitive advantage, ease of use.

Yes they need to achieve the regulatory approvals but they already have Europe to exploit and given sufficient time, those approvals will come because GDR have created a "gold standard test."

Gold standard tests sell, end of. Gold standard tests continue to sell even when sales become price sensitive, which we know from the 12th June presentation, the market has still to experience. That's because there aren't enough tests on the market. Demand continues to outstrip supply.

The hardest thing that GDR had to achieve was the quality of the test itself and its gold standard. Not just good but the best in class. That will sell.

" in terms of territories we are clearly focused on US, we are focused on India, Africa. . .Part of that is driven by where we have existing distributor networks"

"So we have Sysmex and Arkray as existing distributing partners into those geographies"

So whatever the talk of Divoc, real or not, its not critical because GDR have sizeable distribution partners who are being offered the gold standard test for their customer supply chains. That will sell.

"But other countries are lacking in the availability and supply of tests, so they are viable and important markets for us as well."

In a nutshell that is every low to middle income country on the map plus the Arab states, which means it will be all about how quickly GDR can take advantage of what is an embarrassment of riches. Remember the GDR test can be stored at room temperature, which for lower middle income countries in very warm climates with limited facilities, is a significant selling point. That will sell.

"People need to really see and use the product to understand and experience the benefits of having this ready to go product format." That takes time.

"Fundamentally" the route to market will be through distributors. "Sysmex takes us into Asia Pacific and Africa. Africa is probably a good opportunity for us." The majority of Africa has barely scratched the surface on testing and it will highly likely be one of the last palace to rid itself of Covid. Long term market opportunity.

"We also intend to sell direct into those geographies" (Africa and India).

"In the US we are looking for an appropriate partner to get us into the market there." News flow expected.

A gold standard product that has key competitive advantages over its competitors, at this point in the Covid cycle, is absolute gold dust.

I never ceased to be amazed by what I read on these BBs. Investors expecting to be updated on the sales volume of a product that was only approved for sales 6 weeks ago and indirectly criticizing progress on FDA/WHO EUA approvals, that can only begin to be executed, post said CE Mark approval and is independent of the company.

What makes it all the more dumbfounding is that GDR have updated the market on the fact that FDA, WHO EUA and India regulatory approval, have all already been applied for and still its not enough for some investors.

This is a business that is in the process of launching a new product that requires time to bed in and be experienced and understood by its proposed customer base.

I would be more concerned if GDR were rushing out sales updates to satisfy impatient investors, that demonstrated front end trial orders only.

Realistically we cannot even begin to judge this new product's success until minimum year end and even then its merely a staging point.

@mcsquares Understood and appreciated. As investors our main goal is to find companies that deliver us a profit, so that each year we hopefully make more than the last or at least can see that we will eventually make more than we have right now.

Nobody an control when a good investment will be removed from our grasp by bigger money out there. If it is then it should be taken as a compliment to our investment skills. AVCT isn't the only stock in the market and it won't be the last big winner that comes along. Investors would do well to remember that when these stocks get ramped up as not only the best thing since sliced bread, but the only thing since bread was invented.

Do I want to see AVCT bought out cheaply? No. can I truly do much about it ? No. All i can do is make sure i get the greatest return for the least amount of risk and when/if it is bought out, enjoy the fact a profit was made, pat myself on the back once or twice and move on.

@Wiggly Thank you and appreciated. I promised myself I wouldn't get drawn back into LSE but on complicated subject matter, Twitter sometimes, simply doesn't have enough characters available.

Everybody's risk profile and position in AVCT is different. Some are here for a short period of time, some are long, one or two are clearly short, good luck to them all. We either call it right or not. All the chatter in the world on these BBs can't change the facts as they stand, however much we may all try.

Whether big pharma acts earlier or not, is for me not what is critical. Lets not forget that AVCT already has some big pharma type partners on the books. Their diagnostics platforms has discussions/projects with 6 of the 10 largest diagnostic companies in the world. They are on the map to an extent already. What Covid has done is highlight the market and given AVCT a greater spotlight to a wider world. This is clearly demonstrated through the Medusa deal and who is behind it.

Can that, will that force a few existing partners to expedite their plans? Possibly but for me its not really critical because there is already evidence in the market that 'big pharma' is already positioning for future pandemic outbreaks. Its a pattern that for me will snowball. Do AVCT need that interest to be successful? No. Does it help? 100% and it adds another course to this investment meal, which in turns increases the chances and avenues to a successful outcome.

Nobody need play the big pharma is coming card too strongly because there is plenty going on here without it. All of which for me is intensified by the knowledge that the Covid tests, but lets not kid ourselves, the LFT, is suitable for mass screening.

@AfamaMan possible so. The indications to date certainly point towards confidence within the company, that two tests are coming to market. The higher the performance the greater the market.

On the diagnostics front, the Medusa deal is clearly designed for bigger things, be it that the covid tests will drive the platform for both parties. I have absolutely no problem with that, the e-commerce, the connections and the business acumen that the Boohoo based investors bring, is well worth it.

AVCT RNS 19th May ;

Dr Smith ;
"I expect the commercial impact of this partnership to be very significant to Avacta.

Richard Hughes and Mahmud Kamani, Founders of Medusa19 commented:
"We look forward to working with Alastair and his team and to distributing other Avacta products as they become available in due course."

In my opinion, "other Avacta products" isn't based on a whim and a prayer. It was said because a strategy has been discussed and actual diagnostic tests have been outlined. All of which will be driven by Covid test sales. Heck the whole Medusa online platform will gain its fame from people knowing it for Covid testing, which makes future promotions all the more achievable.

I agree wholeheartedly that the Affimers have still be be tested in humans and that risk still exists there but given the size of the current market for Doxorubicin alone, in ts current form as a highly toxic treatment cancer therapy for just 3 cancers (ASTS, breast and ovarian = $1.5BN per annum), coupled with the fact that the Affimer isn't the treatment, isn't the drug or being asked to be such, the risk ratio is extremely attractive for me.

Yes it can still go wrong but as stated, the Affimers involved are being asked to assist the chemotherapy drug in focusing on its target.

Can there be side effects? Yes they could well be. However, the first candidate is a drug that already has severe side effects and and is being used to effectively prolong life in late stage cancer patients. Therefore, and I appreciate it is very a simple analysis here, the Affimers are going to have to be pretty harmful to not deliver a benefit to the patients, given they are already proven to increase the number of cycles of Doxorubicin that can be given, be it to date in mice.

So again, the risk ratio for me, as an investor, is very attractive because of the fact the technology does work and the focus is on a really toxic drug, which despite this, still has an incredibly attractive market. So i'm in.

If the therapeutic partnership for Covid comes good and it is a big enough pharma with enough clout and resources, then a phase 1 trial for Affimers in humans, has every chance of being concluded this year, which as you indicate, de-risks the pre-cision platform considerably (inflection point) and could well be achieved, right in front of said big pharma partner.

This is why I have been saying for some time now that the clinical validation or at the very least, the confirmation of a test, suitable for mass screening, is THE inflection point for this business, for all the reasons I have just explained.

Everything else, approvals, CE mark, manufacturing to an available point, demand, will all follows, once that point is reached.

(2/2)
So for those that are indeed longer term investors here, the success of the Covid tests is not all about maximising the opportunity, be it that we all want to see that happen.

It is also about what those revenues can do for a business that has for some time, had exciting ideas and potential, but didn't always have the attention and certainly not the finance, to exploit the opportunity thoroughly enough. The recent funding is the first leg of that and is for me designed to set up a path that the Covid revenues will truly ago on to deliver.

Whether Covid stays one winter or many, this pandemic has ruffled big pharmas feathers and companies that can demonstrate an ability to deliver against such events, are going to be in high demand for soem time. If AVCT deliver the best in class antigen test that is suitable for mass screening and is demonstrated to have substantial margins and better qualities to antibody based tests, then its going to get a lot of attention. Even more so if the therapeutic treatment Affimers show their worth, which they are doing to date.

All of that is possible from an average sales result but a high quality product.

Now that's what can happen if the Covid test(s) come to market and are reasonably successful, what happens if the test is high performing and fulfills its indicated full potential? What then?

(1/2)
Indeed sleepydave.

Important also not to lose sight of the bigger picture.

A successful rapid antigen test that sells in substantial quantities is fantastic for the bottom line, full stop.

However, in addition, it along with the expected partnership for the Covid therapeutic Affimers, both have the ability to put the AVCT Affimer platform really on the map, in terms of their peers, prospective investors and indeed suitors.

The PR from a successful test brought to market in such short time frames, has the ability to transform the way that the AVCT diagnostics and therapeutic businesses are perceived.

In addition, through both their tests, AVCT are putting in place a fully tested lab to consumer partnership, with minimum Cytiva as manufacturer/product developer and minimum Medusa 19, as DTC distributor and marketer.

All of which will be boosted by the funds that start to come through the door once these tests are on line.

Better still, the funds raised at the start of June, allow AVCT to put in place the infrastructure that will be needed for the ramp up in interest/products, that the Covid tests will drive.

Even better still, the expected profits from the Covid test, even if they somehow fall short of the potential 100s of millions, will generate substantial funding for AVCT other pipelines.

Again, just like with the diagnostic business, the recently raised funds give AVCT the ability to push several of these candidates forward to the clinic, whilst the Covid led revenues are being built up, such that by the time the phase 1 trial for the AVA6000 pro-doxorubicin is completed, AVCT should be well funded to then push onto the next phase, in a manner that suits themselves.

Right now the policy is get phase 1 completed, hit the inflection point and then do a deal with a big pharma. That may remain the case but what cash in the bank does, coupled with bigger facilities and more staff (all paid for by the recent fund raise), is allow better choices for the business to be made or better deals to be struck.

This repeats itself because the recent fund raise has also opened up a number of further opportunities, that can all be pushed forward towards the clinic, whilst the Covid tests are developed and revenues are built up.

June 2020 presentation ;

"Rapidly growing the pre|CISION™ pre-clinical pipeline and delivering pre-clinical packages for several pro-drugs (pre|CISION™ velcade, paclitaxel and oxaliplatin)."

"IND/CTA filings for one or more Affimer immunotherapies (TMAC drug conjugate (PDL1-IDASH) or first bispecific candidate) and one or more pre|CISION pro-drugs."

That's what is truly exciting here and really doesn't need huge Covid test success to be achieved, be it that it comes after a longer period of time. said time doesn't remove its reality. All of which is further added to if as expected, a big pharma gets involved on the Covid side and proves up Affimers in humans first.

As I said earlier, we have a live version of this process with Cytiva involved, over at GDR.

@Ophidian Thank you, then based on that knowledge one would assume that Cytiva would run the main clinical validation batches and complete this process, with parallel tech transfer to other manufacturers/OEMs,

@Kaysee I would encourage you to listen to the Vox presentation at c. 15 mins. There they talk about the process post prototypes be it a simplified version. The manufacturers will produce the pilot batches for clinical validation. My understanding is it will be each manufacturer that does this, to prove consistency for reg approval.

As a side note, those that know GDR, they announced their tie up with Cytiva for their PCR bead test, an existing partner of theirs, on 22nd April. At that time they stated 5 weeks until product was on the market.

Cytiva ran pilot manufacturing batches by 1st May and the CE marked product was announced by 22nd May.

Total time 4 weeks and 1 day.

AVCT test being for consumer use may require a little longer but as i have said previously, the ehalthcare professional use, as laid down by the latest MHRA guidelines (see below) for POC tests, talks only about professional use. For me there should be no difference.

It may be that the consumer self-test version will require more validation in its intended setting but fro use in Hospitals and healthcare professional led POC, the process should be the same. Hence why a late August date should be well within reach.

https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/895745/TPP_Point_of_Care_SARS-CoV-2_Detection_Tests.pdf

@Seaogsteve as far as I understand that test is the one they were interviewed about on Mad Money back in March 2020. I believe it is their own product.

Here's the VOX markets presentation. Not loved by some but still full of interesting information and thus useful.

Dated 12th June, the point at which it was known that AVCT had "a high level of confidence of having prototypes by the end of June."

Dr Smith still stating "clinical validation and regulatory approval as soon as possible in the summer."

In addition, on manufacturers he said ;

"Once we have those prototypes. . . the performance of those we can then evaluate and look at transferring to manufacturing. We are putting those manufacturing partner sin place in the UK right now."

Not trying to find but putting in place right now. 12th June update.

All part of the "as soon as possible in summer" process.

https://**********.brand.live/c/avacta-Investor-presentation