Member Info for B2HS2L

ahhhh, - that'll be Southampton / Camberley / Paris then.

Perhaps we should consider that GM advised that he was looking to perform some M&A activity in H1 2021.
This was stated shortly before purchasing IT-IS International, (October last year).

This being the case, if he wants to keep to schedule, he might be starting due diligence any time soon, for an end of June timescale, plus and minus six weeks ish.

In order that nothing gets leaked about said opportunity(s), he will have doubled down on all the different forms of communication that a company's employee's use with media, partners, customers, agents, and especially PI's.

That is a mammoth task for a company recruiting so many new faces.
How would he know which to trust etc, so I'm not sure if new staff are even aware that M&A might be a possibility.

Going through contracts with lawyers and DHSC will be a distraction for sure, but reasonably confident this may be what a fly on GM's wall might overhear ;=)

Add that lot to consideration of any offers received, and I'm not surprised GM is not saying anything, - must be like Fort Knox in Southampton.

Just a few thoughts.

I was spiked on £5 / share for 5 months, April - September 2020.
That's a long time to be uncomfortable, but patience paid off.
We are back below £5 now, but the difference is the fundamentals are better,
now we have a new genomic surveillance income stream, and very little serious competition.
The starting gun was fired 24th March, and I'm hoping production has kept up with demand.

Hi MS -

How about that M&A activity scheduled for H1 2021.
What is Anthony Dyer doing with his time these days, - don't we have enough cash for his plans?
We haven't got anything to show for his work since he became Chief Corporate Development Officer on 05.01.21

Naewise, What timescale did you have when you invested?
It's easy to make timescales longer when the sp is rising.
Even easier to make timescales shorter when the sp is falling.

We know nothing at all about Genomic Sequencing sales other than few competitors have an equivalent product, let alone a CE-Approval.

Will be checking FDA EUA approvals of competitors products later.

Note: CE-marked VariPLEX product launched 24.03.2021, and they were distributing RUO samples to everybody who might have an interest before CE-label award.

From the Primerdesign 3 gene IFU:

Sample Types

Nasopharyngeal Swabs
Oropharyngeal Swabs
Saliva [ **<----WBAFC** ]
++++

PCR Platform Q32 (not Q16).

From the Primerdesign 3 gene IFU:

...As with most viruses the SARS-CoV-2 also mutates, and the changes in the genomic code have resulted
in the emergence of the virus variants. These variants are suspected to have altered the
transmissibility rate, impact on the body’s immune response and, possibly have effects on
vaccine efficacy (4). Timely and accurate diagnostics are thus crucial for clinical treatment
of patients, public health decision-making and contact tracing, infection control practices
and personal protective equipment (PPE) use and avoid overwhelming our health-care
system.
Recent prevalence of mutations with potential biological significance within the Spike
protein of SARS-CoV-2 have raised concern over the most effective targets in COVID-19 for
Real-Time PCR based diagnostic methods, suggesting the need to test for more than
one target at a time. The genesig® COVID-19 3G assay has been developed to target three
genes to ensure the accuracy of the genesig® assay.

The bioinformatics surveillance report will have to be modified to account for this product in future.
There is no mention of 3G in the report dated 09 April 20201 on LinkedIn, - Novacyt Group.

3G Covid-19 Assay IFU:
https://www.appletonwoods.co.uk/wp-content/uploads/2021/04/Path-genesig-COVID-19-3G-CE-STED-IFU-Issue-1.0.pdf
+++++

This assay has been developed to ensure we maintain our 100% detection track record, (ie future proof the 100% detection), in the expectation of future variants, particularly relevant to future VoC's.

++++

The SNPsig handbook states:

...The RNA obtained from the confirmatory primary assay for SARS-CoV-2 should be used.

So the SNPsig assay requires a Covid-19 positive sample to have been successfully processed, and with the RNA generated to be input to the SNPsig surveillance assay.

So if a new variant on a swab returns a negative PCR test, (this happened with the Breton variant recently), there will be no RNA available for surveillance, and nobody will be aware there is a new variant.

This is where I believe the 3 Gene assay will prove invaluable.

:)))

Wilson, - Well it might have been 5 weeks, - but it was certainly a marvellous recovery.
I hope your pleased with progress so far.

CT - Bakky was only talking about qPCR assay, not SNPsig.

Yes thanks, Bakky, I wasn't aware of the competition.
Certainly the number of assays offering 100% detection of all variants has reduced now, (as FDA have been advising).

Indian authorities will surely be giving much attention to those assays offering 100% detection.
With a population that size and present rate of infection, I expect quite a number of variants from India in the coming months.

Yes thanks Deas
My takeaway from this was
"How buyers award work can also vary depending on what the framework is for. For example a service based opportunity may prove difficult to allow a direct award, so the framework would need to be set up to allow for mini competitions, whereas a product may be offered via a direct award. "

1 The Primerdesign qPCR assay is the only one that detects 100% of all variants, - so I would not expect a competition for identifying positive / negative Covid-19 PCR results.

Likewise -

2 The SNGsig assay currently is the only one with a CE-IVD Approval, so I would expect a mini-competition in future, when competitor products are available, but not presently, as our product is unique in respect to Approvals.

If the framework is for 4 years, the buyer can pick the winning product from those who can supply in the time available, the price available, and the functionality available, as competitors may be improving their offering continually.

I don't think a supplier is going to offer the same price for his product for the whole 4 years.

I can see a pathway beyond £15 / share, because there are only 70 Million shares in issue.
There are quite a few 'compromised' PCR tests now, they cannot identify a positive sample with certain variants on the swab.
The NCYT test has 100% detection, and publishes documentation regularly to prove the assay detects all variants.

Part 2

With a laser-focus on the task at hand, the six-person Chartwell team
coordinated the operational effort to increase production capacity up to a rate of
ten million tests per month by June. This included guaranteeing the sustainable supply of all
critical raw materials, ranging from thermophilic polymerase enzymes
to the humble but highly soughtafter plastic test tube, to not lose a single minute of
production due to material shortages. Working through the UK’s summer lockdown had its own unique
challenges: the team travelled armed with a government-issue key-worker letter to ensure safe
passage and adapted to life in a Chartwell ‘household’ just outside Southampton until lockdown
restrictions were eased.
Equipped with the Chartwell methodology and an unwavering determination to succeed, the
team ensured Novacyt was able to scale-up and meet the sudden increase in demand from
organisations including the UK Department of Health and Social Care (DHSC) and AstraZeneca in
their collaboration with GSK and the University of Cambridge.
The result for Novacyt was a transformational first half of the year,
with revenues soaring by more than 900 percent to £63.7m ($82.7m) over the six months to June.
With more than 91 per cent of that figure arriving in the second quarter alone,
the company expects second-half sales to be even greater than the first – with margins
at least at similar levels.
As the Northern Hemisphere winter approaches, rates of infection are again increasing around the
world. Whilst a vaccine remains in development, the requirement for mass testing is as high as ever.
The Chartwell team continues to offer a dynamic solution to Novacyt, pivoting as required to support new
product developments, an entire new testing workflow for rapid near-patient testing (NPT), and
the coordination of clinical trials to underpin the developments.
As the testing efforts continue, we at Chartwell remain proud to be supporting a UK-based business
as it continues its transformational journey into a crucial element in the global fight
against the COVID-19 pandemic.

Scrambled, - don't forget Chartwell consultants part in getting finished product developments to market so quickly.
Taken from Chartwell Consulting Autumn 2020 Newsletter.

Part 1

Never has this ambition been tested as much as in early 2020.
As the new year began our team were supporting established clients across the
globe including China, Italy, and the United States.
Within weeks, travel to these places was heavily restricted, supply chains
disrupted, and new products were being rapidly developed in the fight against COVID-19.
With such a monumental shift in the global manufacturing landscape, the Chartwell team
quickly refocused: supporting existing clients where possible – often remotely –
and identifying areas where our skills could most significantly support the
challenge facing society.
Simultaneously, Primerdesign, a molecular diagnostics firm based in Southampton, UK, became one
of the first companies to develop and launch a polymerase chain reaction (PCR) test for the
2019 novel coronavirus.
This test subsequently received a CE-Mark, and emergency-use approvals from both the FDA
and WHO, sparking a surge in demand from laboratories and healthcare providers across
the world.
Graham Mullis, CEO of the Novacyt Group, Primerdesign’s parent company,
recognised the challenge – and opportunity – that his team were presented with, and called on
Chartwell to guide the organisation through the operational scale-up. Tasked with managing the
planning, procurement, and logistics, the Chartwell team, led by Partner Andy Redfern, worked
tirelessly throughout April and May as governments worldwide raced to place testing at the
forefront of their virus-control strategies. Away from the politics and media fixations
around daily testing targets, the team of senior Chartwell consultants grew Primerdesign’s
manufacturing supply chain from a single laboratory in Southampton to a cross-European network of
eight manufacturing sites, fed by a global supply chain providing the 76 components required to
manufacture each test.

Vadim Alexandre and Justin Waite ramble on about the contractual dispute with DHSC.
Piffle, as there is much unnecessary discussion about past sp performance.
Neither has realised that the Primerdesign assay that sold so well, is one of the few assays that detects 100% of the virus mutations, and what that fact will do for future test sales.

If the shelf life of PROmate is 6 months, - I previously tried to estimate this on this BB, - then the statement in the 09.04.2021 RNS,
"the Company believes that Q1 PROmate sales may be sufficient to support the NHS current roll out plans for the remainder of 2021"
only works if the NHS roll out plan ends well before the shelf life precludes further distribution, (ie Sept 2021 not the whole of 2021).

I have tried to verify PROmate shelf life with Primerdesign support, but no response.
Perhaps someone with personal contact with an employee might ask this question?

Within the Sept 29th AGM video, GM stated "In terms of our investment in R&D we are very clear on which market segments we are going to work on and will be developing a 5 year plan with a number of pipeline opportunities to exploit
the opportunities that we see in the respiratory and transplant markets."

That was before Genomic Sequencing took off for the company.

He hasn't mentioned 'Transplants' again since last Autumn, but half expecting it to resurface in Q2 briefing re future path.

Well said L&L, they should have called the Indian variant 'India01', because there will definitely be more surface within a population that big!

https://www.theguardian.com/world/2021/apr/15/covid-variant-first-detected-india-found-uk

The B.1.617 variant was first detected in India, but has since been found elsewhere, including California. It has worried experts as it contains two mutations in the spike protein that, it has been suggested, may boost its ability to escape the body’s immune responses. It is thought the variant may also be able to infect the body more easily.

Prof Paul Hunter, professor in medicine at the University of East Anglia, said the arrival of the India variant was potentially worrying.

“These two escape mutations working together could be a lot more problematic than the South African and Brazilian variants who have only got one escape mutation,” he said. “It might be even less controlled by vaccine than the Brazilian and South African variants.”

If what you have said is correct RBM, it will not be very long before the size of the problem with using these tests in this way is revealed.
As PM, how will Boris deal with that evidence once it is available, - he will for sure have blood on his hands if the problem is large.

In one company I invested in, a share holder owning > 5% of the company, wanted to be represented on the board, and did this by using his shareholding to call a General Meeting under section 303 of the Companies Act 2006.
His proposal included board member deletions and additions, and as it happens he succeeded.

I'm not saying this is the reason for acquiring >5% holding, but that is one way to use such a holding.

https://www.legislation.gov.uk/ukpga/2006/46/section/303