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@Monkshood excellent post and thank you for taking the time to share with the BB.

Just to add, the BAMS test is 'currently' being "tested using patient samples. . . in the UK and the US."

The LFT will be tested at sites in the UK "to begin with."

Everything happens for a reason. So there's a very good reason why the US test is happening in parallel. In addition, Adeptrix are US based.

So UK capacity is certainly relevant, the BAMS test clearly has plans to seek out a bigger audience with US and US FDA driven markets, certainly a part of that.

@Magsy18 I don't believe it would be good for either of our healths or indeed this BB, if we got into a debate on this subject once more, so I will tread carefully.

Firstly, an E-Mail from the PR company is of little value at all and should be placed in the context of what said 'representatives' are and are not allowed to say.

Taking that one step further, nothing written by said PR company can be taken to be accurate because the very thing that you are keen to be right about, "first commercial sales" cannot be communicated outside of a regulatory update.

To explain. You believe that first commercial sales are price sensitive and so must be reported. By believing as much, what you are inadvertently buying into, is that the PR company representing GDR, have through a one to one communication, provided price sensitive news flow, by confirming that there are to date, no sales.

If so then said PR company has over stepped its mandate and contravened the same AIM rules, you are keen to highlight.

Given that the PR company will know what it can and cannot say, it is highly likely that that is not what said representative is in fact saying.

"if there was significant news on regulatory approvals and first commercial sales"

can be taken to mean ;

"significant news on. . . first commercial sales"

That is not saying no commercial sales, it is saying significant commercial sales, which is exactly what David Budd said, in the 12th June update, when he talked about significant orders associated with distributors or customers.

I repeat, you cannot bash the company over the head with the regulations but then accept an E-Mail, sent in good faith I might add, from the PR company, as communicating the very price sensitive information, you are calling the company out against.

@O&W I have to say, having witnessed your offerings for a number of years now, I am a tad surprised by your post.

GDR have produced a gold standard PCR test with the "best in class" manufacturer, in just 9 weeks. An achievement that is easily brushed under the carpet by a self induced panic, driven by a perception of missing out. That is no 9 to 5 job that they have carried out there.

A company that works that hard to produce such a high quality test, is highly likely not going to then throw all its hard work away, by not preparing its regulatory paperwork on time or attacking markets that are available to it.

"The Company anticipates launching the Genedrive® 96-SARS-CoV-2 in May 2020."

On 22nd May GDR launched its product with a CE Marking that allows it to sell its product in Europe (see presentation below from 13 mins on wards). The statement does not say that we will be shipping 6m tests out upon launch. That is a perception driven by the mind of the reader.

https://api.**********.co.uk/v2/widgets/media/GDR/single?mediaID=5ee9c79a9f98da001bbc4b07

The same presentation states, as of 12th June ;

WHO EUA APPROVAL
"WHO EUA applied" and this statement is backed up by CEO Daivd Budd comments.

"I cannot comment on how long that takes because the WHO does not communicate that back when you apply."

"The combination of WHO approval and country specific approvals is certainly what we need to get into these Africa regions."

More importantly ; "i personally don't think that WHO approval is a must have, in order to sell into Africa. We certainly see African countries currently procuring and making their own decisions, in the absence of WHO approvals."

INDIA
"I will confirm that we have applied and are engaged in the registration process."

FDA APPROVAL
"we have applied for EUA with the FDA, so we are in process there again."

Why do those 3 processes need to be any more complicated than that? Why is a company that achieved such a rapid product development, not entitled to a little space to breathe, in order to achieve regulatory approvals that are outside of their control and commence sales.

The product is more than good enough to achieve market penetration.

It is important not to forget that a key advantage of the GDR test, is that it can be stored at room temperature. It is therefore ideal for the African and Indian markets, as a starter for 10. Those markets are highlighted by David Budd in the Proactive interview from 29th May.

The company believes it can get into these markets without WHO Approval. However, if it takes a little time to achieve said approvals and it is they that truly drive the sales, then it will be more than worth it. As things stand, the market for high quality, easy to use, PCR testing, isn't going anywhere, especially in Africa and India and likely a good many regions too.

https://www.youtube.com/watch?time_continue=2&v=HCiOLYEcWJ4&feature=emb_logo

So that puts us very close to 1.7 billion of those 2 billion doses, highly likely not seeing the light of day until year end, at best.

Am I happy about that? No but at the same time I don't like the idea of these rapid development programmes that appear to serve the wrong people and the wrong purposes. Plus fact is fact and cannot be avoided, however much we want it to be true.

and the damn thing still has to do its job, which to date nobody knows its capable of.

AND! to top it all off, the talk on the town is that 2 doses of the Oxford vaccine will likely be required for it to be effective, so everything potentially needs to be halved.

Last one from me for a while.

Back to our debate on those 2 billion Astra Zenica vaccine doses.

Remember we were at 700m doses.

"AzstraZeneca and Serum Institute of India (SII) have reached a licensing agreement to supply one billion doses of the Oxford University vaccine candidate against Covid-19 to middle and low income countries, including India."

https://economictimes.indiatimes.com/industry/healthcare/biotech/pharmaceuticals/astrazeneca-serum-institute-of-india-sign-licensing-deal-for-1-billion-doses-of-oxford-vaccine/articleshow/76202016.cms?from=mdr

Here's a tweet from the CEO of that same Indian private company Serum Institute of India, regarding the deal ;

"to exclusively manufacture their product for India and @gavi countries, up to a billion doses annually."

A billion doses annually. Not by Autumn, in fact not this year at all.

https://twitter.com/adarpoonawalla/status/1271700534609707010?s=20

Now AZ claim the deal calls for 400m doses by YE. However, the following interview with that same CEO says different.

Dated 3rd July it says "we plan to start production in nearly two months" and "we will start making a few million of doses, and stockpile at a personal risk."

So the first few million doses appear to be starting production in late August/Sept and "furthermore, as per our deal with AstraZeneca, we will start making 1 billion doses for India and other low- and middle-income countries."

But "we will conduct these trials in India as well," which tom date do not even appear to have been planned. It will take some effort to produce those 400m doses by the end of this year, given they expect 1 billion per annum, which is maximum 83m per month and they start with their first few million, best case, late August and they haven't even commenced their own trials.

Its easy to get lost in a headline and a big pharma's marketing campaign that claims to be saving the world, whilst taking over $1 billion in payment s from the US authorities but as always, the devil is most certainly in the detail.

https://www.tribuneindia.com/news/nation/when-coronavirus-vaccine-will-be-available-at-what-price-adar-poonawalla-ceo-serum-institute-of-india-explains-107991

More from that Astra Zenica announcement ;

"Based on these pre-clinical results, the Company has signed an exclusive license to six candidate antibodies currently in Vanderbilt’s portfolio that target the SARS-CoV-2 virus. Two mAbs from these six will progress into clinical evaluation as a combination approach within the next two months."

From the latest AVCT diagnostic test performance video (7 mins 50s).

"33 Affimer reagents that bind SARS-COV-2 spike protein and also inhibit the interaction with ACE2"

AVCT didn't just find one or two possible candidates, they found 33.

What does that say about the quality of the best candidates in that very large number? What does that say about a deal getting over the line?

https://avacta.com/how-diagnostic-test-performance-is-measured/

@gmcc Thank you.

The following article is from Astra Zenica themselves, you know that famous big pharma that is apparently going to deliver the killer blow to Covid by Autumn.

Its dated 9th June and talks about their "coronavirus-neutralising antibodies" and their "plans to advance a pair of these mAbs into clinical development as a potential combination therapy for the prevention and treatment of COVID-19."

Astra Zenicas Executive Vice President, BioPharmaceuticals R&D, Mene Pangalos ;

"By combining two monoclonal antibodies that bind to distinct parts of the SARS-CoV-2 spike protein into what potentially could be a single preventative therapy, we hope to improve its effectiveness in neutralising the virus."

AVCT RNS dated 11th May ;

"Affimer reagents that can work in pairs, both binding to the spike protein at the same time. This allows tests to be developed that detect both the intact virus particle and the detached spike proteins which become separated from the virus particle during the development of the COVID-19 disease, which may also be important in monitoring disease progression."

Comments made about the test but the principle is the same.

If Astra Zenica, the manufacturer of the most advanced vaccine candidate in the world right now, is now just gearing up for neutralising therapy trials, then the law of averages say that those AVCT Affimers are going to/have created "considerable interest" and a deal will/is getting done.

https://www.astrazeneca.com/media-centre/articles/2020/advancing-our-discovery-of-novel-coronavirus-neutralising-antibodies-against-covid-19.html

That should have read "considerable interest" in my last post.

@CautiousOptimist In terms of the neutralising Affimers, here is the set of tweets I produced on this (not advertising, its just where I publish the majority of my work).

"It took Vir Bio c. 56 days from the point of announcing antibodies that bind to the spike protein of Covid, to securing a $250m investment from GSK.

#AVCT are currently c. 46 days in."

As of today that timeline has now moved on to 52 days.

However, no two paths are the same and I am tending towards believing that the next stage in Dr Bhella's work for AVCT; is to test the Affimers against live virus, which is as far as Vio were, when they struck the deal with GSK.

The AVCT official line states "Work is continuing with Professor Bhella to further study the way in which the Affimer reagents prevent infection," so it is my view point only.

Whatever the case, if those Affimers really are receiving considerable evidence, then AVCT is right in the getting a deal done zone.

https://twitter.com/BigBiteNow/status/1273526177324466181?s=20

As I have stated in previous posts, a successful vaccine will help with the fight against Covid, but it highly likely cannot get the job done on its own. It is instead a part of a wider strategy that requires extensive easy to use POC testing. Even better if said testing can be de-centralised and pushed onto business and individuals themselves.

With that known, I am back to my previous view point, that the only thing stopping AVCT from selling a significant amount of these tests, is either ;

a. Covid blows itself out or,
b. The test is not good enough use as a mass screening tool,

but even then, it'll still sell.

For those with access to Twitter, here is a series of tweets I produced on the launch of the Oxford/AZ vaccine trial in S.A, with quotes from the clinical trial lead scientist Prof. Shabir Madhi, who is Professor of Vaccinology at Wits University and Director of the South Africa Medical Research Council (SAMRC) Vaccines and Infectious Diseases Analytics Research Unit (VIDA).

"Oxford vaccine is the most advanced in terms of clinical development."

"best guess right now is probably around about Sept/Oct of next year, provided that we actually show that the vaccine works this year." Taken to mean S.A. and Africa wide availability.

"longer that we delay being able to show that the vaccine actually works, the further it pushes out the timeline."

"scientific data will also be used by the WHO in terms of its recommendations as to whether this vaccine should be used, in low middle income countries"

"study that is currently under way in UK has already enrolled more than 4,000 participants" in that particular phase 2 study & over the next 1 or 2 months plan to go into a phase 3 study, which is a sort of pivotal study which determines if the vaccine is actually working"

Dated 23rd June 2020 and talking about phase 3 trails commencing over next 1 or 2 months. That places roll out in Autumn severely under pressure, given the results have to be fully analysed to prove efficacy, in order to gain at the very least, EUA approval or whatever form of approval the UK and other jurisdictions choose to apply. Those things do not happen quickly even for diagnostic tests, vaccines are a different ball game altogether. I am sure that things will move very quickly if the vaccine is a good one but it remains a very tight time frame, such that the late 2020/early 2021, indeed looks best case scenario, percentage wise, for the start of roll out.

Further links include the full Guardian interview with Prof. Pollard of the Oxford Uni vaccine team, which is well worth a detailed listen to, as he talks about the tendency for a lack of immunity in over 70s, when given these sorts of vaccines. Therefore, those members of society will gain protection from herd immunity, which brings us back to efficacy and roll out once more. All the time this is going on, testing takes centre stage.

Last of all, I have included the latest guidance from the FDA (30th June) on what is required to achieve approval for a vaccine.

Key lines ;

"To win approval, any vaccine must be at least 50% effective in preventing the disease."

"It sets a bar about on par with a flu shot's performance in a good year."

"An efficacy figure of 50% would compare somewhat favorably to flu vaccine efficacy in the last decade, which has ranged from 19% to 60% since 2010."

To achieve herd immunity, the very first Covid vaccine attempt, has got to out score all flu jabs of the last decade and it still might not be enough.

https://twitter.com/BigBiteNow/status/1276422954465796096?s=20

A key point t consider is the difference between supply capacity and actual ability to produce.

@alwayswinning I fully appreciated your later correction with regards to the Astra Zenica/Oxford Uni vaccine candidate. It is currently deemed to be the most advanced outside of China, whose efforts to date are clouded to say the very least.

From your post of last night at 21.25pm ;

"If the vaccine works and the clinical trials prove a success, it looks possible that we could see a vaccine distributed to the entire country and possibly over a quarter of the world by Autumn given they are producing billions of doses already."

I could come at this from several different angles and may indeed come back to you later. However, first and foremost and example of why that is not the case ;

As of 4th June Astra Zenica have stated "Global supply capacity to exceed two billion doses" which includes the deal announced that day with "CEPI and Gavi to support the manufacturing, procurement and distribution of 300 million doses of the vaccine, with delivery starting by the end of the year."

https://www.astrazeneca.com/media-centre/press-releases/2020/astrazeneca-takes-next-steps-towards-broad-and-equitable-access-to-oxford-universitys-covid-19-vaccine.html

Here's CEPI own announcement, where they state ;

"If the vaccine is proven to be safe and effective, the first doses to be produced under this agreement are anticipated to be available in early 2021."

"Vaccines will be released on a rolling basis as production is completed, and the full quota of 300 million doses is expected to be available by July 2021."

CEFI CEO commented ;

"AstraZeneca and our other industry partners have a critical role to play in rapidly developing safe and effective vaccines and manufacturing the billions of doses needed to put a permanent end to the COVID-19 pandemic."

Not the end of Covid but the end of the pandemic, if the vaccine is proven to be "safe and effective."

Said vaccines have to find their way to what are some very limited health care systems around the world, such that having the doses is one thing but managing the administration of them to a sufficiently high enough number of people, is something else altogether.

https://cepi.net/news_cepi/cepi-partners-with-astrazeneca-to-manufacture-300-million-globally-accessible-doses-of-covid-19-vaccine/

What about Europe?

"AstraZeneca has agreed with Europe’s Inclusive Vaccines Alliance (IVA) that it will supply up to 400 million doses of the University of Oxford’s COVID-19 vaccine"

"will see deliveries start by the end of this year"

Start not completed. Then there's the same distribution and administration issues as highlighted earlier, if it indeed proves effective enough.

So that's 700m doses of the proposed 2 billion currently on the table not commencing deliveries until late 2020/early 2021.

http://www.pharmatimes.com/news/az_signs_deal_with_europes_iva_for_coronavirus_vaccine_supply_1342267

@alwayswinning You are entitled to your opinion but I believe you getting this very wrong indeed.

The whole time frame debate is like a broken clock and I have explained very clearly that your perception and the reality are proven to be different by the facts.

More importantly, no vaccine is going to remove AVCT ability to make "mega bucks" from their test over the 2020 Winter.

The only things stopping that are Covid itself deciding to disappear or the test not being suitable enough for mass screening. That is where we are at now.

The demand question has for me, clearly been answered. There was an investment concern (not health or social) that the Summer months may really drive it down but it has become clear that this virus is very good at spreading even in hot humid weather. The likes of Arizona, India and Brazil, put that question to bed. Furthermore, it is now in countries that either cannot control its spread or have lost the desire to, which could prove very costly come Winter.

Once the front end "mega bucks" have been made, which actually may last a great many more months than you are currently deciding to contemplate, then the 'residual' profits, have the ability to support a higher valuation than we see today. However, by the time this front end test market has run, AVCT will be a completely different animal and other parts of its business will be fully in play.

You talk down the therapeutic deal but fail to understand that if a big pharma buys into the trialing of Affimers in humans and goes on to be the on that tests them first, then very big eyes will be on their potential moving forward.

If you understand Affimers then you will appreciate that their true value sits not in being actual treatments themselves but as assistants to existing approved drugs, in doing their job better. A role that has already been proven in mice. The test is to see if they have side effects that are strong enough to prevent their use in persons who are already dying and are being killed by the very drug they are being given. That should resonate very well in a good investors head.

In 2021 the existing "mega bucks" deals with the likes of LG Chem start to come to fruition also. JVs such as that can be further enhanced by residual revenues, that themselves demonstrate to the market that AVCT ca progress, without further large dilutive actions. Such knowledge adds further value.

I could go on but I know you either don't wish to see the enormous opportunity here or you simple cannot see it, which is why these posts aren't really for you, they are for those that might actually think, that what you are delivering, has been extensively tested through thorough research.

What amazes me is the thought process that a successful vaccine somehow completely removes the demand for POC consumer based Covid tests.

A really good vaccine candidate could perhaps achieve 70% herd immunity but that still does not remove Covid from the world, even if logistically, we could get that vaccine willingly into 70% of the world. A project for which, the time frames are potentially very long indeed, if indeed 70% of the world is willing to be injected. During which we all have to hope that the virus does not mutate and bypasses the very solution that has been created to stop it.

But lets say the willingness is there and lets say somehow, the very first candidate has the ability to deliver herd immunity, there will still remain a world wide market for POC self tests. The market won't be as big as the front end oft talked about 100m plus but it could still act as a good earnings driver for AVCT, supporting its other work on cancer treatments and new diagnostic tests with its new found partners. 30% of the world is still a very big market and severe Covid cases will still occur, given vaccines generally, struggle to protect those over 70 years of age. That being th eage group most vulnerable to Covid. So hospitals, doctors surgeries, chemists, will still stock Covid tests, especially in Winter. That's what happens when a virus is endemic.

In addition, the time needed to roll out of the vaccine, observe it effectiveness by seeing a longer term drop in Covid cases, plus no doubt an extended monitoring period (which itself will be mixed with, at the very least, a flu season, which itself will drive more testing, as people, businesses etc, all seek to check that symptoms being shown aren't Covid), will lead to a large upfront market, that will be at least 12-18 months, even with this golden arrow candidate, which has very little chance of delivering that 70% figure in the first place.

All of that assumes the first vaccine is a very good one and can be rolled out quickly. According to the S.A. clinical trial leader for the Oxford/AZ vaccine candidate, Africa won't see first roll out (Not herd immunity) until "best case" Sept 2021. That trial of just 2,000 people, is being employed by the WHO to determine the vaccine's safety for use in lower to middle income countries and will support the WHO's decision making on recommendation for release in these countries.

With the US trial still to begin (30,000 people) and the UK trial still to complete it roll out (6,000 more to go), how can AZ be so confident about a Sept roll out, when the S.A. equivalent trial, that is ahead of the US at least, is talking up Sept 2021?

Perhaps we will still see something very special take place but the odds are certainly very much against it and even if everything goes right, POC tests especially those that are easy to use and can be bought over the counter, are going to sell very well and will sell for a very long time indeed.

No alwayswinning anything but. . My view is as per my post, that late August can be achieved and I have demonstrated this in detail in my last few posts.

An Important point.

This debate is sport. It has no bearing whatsoever on the success of this investment. If for some inexplicable reason the test makes it to market in October, as things stand, it will have no long term bearing on the success of the antigen test. It will not undermine the ability of this test to sell in substantial quantities over an extended period.

However, to be clear, the company post your perceived 3 week delay, is still aiming for a CE marked test for sale in Europe, this Summer.

There are still some risks to be overcome as with any product development but to be clear, the data published by Sona yesterday, coupled with the timing and wording employed by the AVCT CEO yesterday, are extremely bullish for this share.

What I quoted was the most up to date programme as currently understood by a company that is conducting a complex and expedited process.

That up to date process concludes that this test will be coming to the market, CE Mark approved, this Summer.

I have consumed a great deal of information from this company, many times over and at no point did AVCT "promise" prototypes in early June. What AVCT did state in their 6th May presentation was that ;

"Cytiva aims to have prototype lateral flow devices over the next few weeks."

Now we can pull the "few" apart as much as we like but all that does is demonstrate that there is wriggle room, which when producing a lateral flow test is understandable.

However, if you wish to state early June and the prototypes came 24th June, then yes we could say that they are running 3 weeks behind their intended process.

So when in that same 6th May presentation, Dr Smith goes on to compound that same "as soon as possible in the Summer" statement on slide 24, by saying "so middle of Summer is what we are aiming for." Not promising but aiming.

However, running with that aim we can say that they planned to hit very early August or around about 1st week of August.

If the prototypes landed 3 weeks later then in very simple terms we are back at my anticipated date of late August once more.

The optimisation card can be thrown in once again but it is a valid and recognised part of every lateral flow test process. See below.

"When developing a multiplex lateral flow assay, optimize, optimize… oh and optimize!"

https://www.cytivalifesciences.com/en/us/news-center/how-to-guide-multiplexing-your-lateral-flow-assay-10001

All opinions should be respected and are entitled to be shared. No one person's opinion has more right than anybody else's.

Here's mine.

"if you'd been following the company and everything it's said thus far you'd be aware that. . . "

On 12th June in the Proactive interview AVCT stated that "we are aiming for prototypes to ready in June" and Dr Smith verbally clarified as being "we anticipate having prototype devices by the end of June."

In addition, the presentation stated said prototypes would be "for testing with models and patient samples"

"before tech transfer for manufacturing, clinical validation and regulatory approval as soon as possible in the Summer."

So as of 12th June, with everything that would have been known at that time, the delivery of prototypes by the end of June allows the company to obtain regulatory approval before the end of Summer.

End of Summer is c. 21st Sept.

The prototypes beat the 30th June date by c. 1 week.

However, as we are following everything the company said, he didn't say end of Summer. That is the long stop date as things stand. He said as soon as possible in Summer.

In terms of the optimisation process, that is not a surprise. It is a validate step in the development of a diagnostic test and would have been known about when said above remarks were made.

Furthermore, Dr Smith in his comments, compounds the understanding of "regulatory approval" as being "a CE Mark."

A CE marked diagnostic test, at the very least, allows sales to commence in Europe for use by healthcare professionals.

Said sales will take time to build up and other regulatory approvals must be sort. However, the most current guidance from the company is that Summer is very much on and my view, having seen what Sona have achieved, is that late August or early Sept is about right.

@O&W there are contributors here with stronger knowledge on viruses than me but my understanding is that a mutation does not guarantee a need to change the test. Also some other forward thinking test manufacturers may also be doing the same as AVCT.

However, I agree that a dramatic mutation (that being a mutation of a part of the virus that mainstream testing has focused upon to generate its binders), would seriously disrupt the testing market and give AVCT a chance to demonstrate the speed with which it can react, which is a big positive for company value.

However, I pray that does not happen because vaccine studies would come under pressure and life could be severely disrupted for a very long time.

@O&W Have a listen to the Q&A section of the 6th May webinar, from around about 55 mins 40s.

"we are in parallel developing other Affimers agianst other targets on the virus, that are less likely to mutate, if that becomes an issue."

"Everyone's seen how quickly we can produce new binders to a new target."

"If the world was put into a terrible position where this virus mutated dramatically, then we would simply generate a new test."

Dramatically been the key word and absolutely nobody should want that to happen but if it did, who is going to be quickest to market?

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