Member Info for Muck165

Don’t disagree Regulator - she’s as slippery as they come.

Confirmation here about govt LFT stock levels (at least as at 13/12)

https://questions-statements.parliament.uk/written-questions/detail/2022-01-04/96927

I’m assuming that supply of the now defunct antibody had already been secured. If a replacement is found, do we envisage supply issues at all?

“We will therefore use the robustness of the Affimer(R) platform, and what we have learned about the SARS-CoV-2 virus, to generate the next generation antigen test that will be as resilient as possible to any future mutations.”

Anyone else think this might target both the S and N genes, as well as deal with the Mab issue?

For info - https://www.aconlabs.com/acon-laboratories-issues-a-nationwide-recall-of-non-eua-authorized-flowflex-sars-cov-2-antigen-rapid-test-self-testing-tests/

Are you able to copy and paste it HD? Thx

Aren’t AffiDx and Meduflow exactly the same thing?

Interesting stuff on the AVCT board re this

https://www.poctrn.org/itap

The FDA policies already say that any test supported by NIH/Radx gets a priority review. The link highlights a fast track NIH/Radx process which is available for any test with self test approval in major markets. That is now AffiDx/Meduflow…

Rumours are circulating that M19 has applied for this…but they are no more than that.

Me too - Myles Tweet on it was interesting earlier when replying to a comment suggesting an RTO

“ Hi Tim, yes that deal has been in the works a long time, I believe Thumbs up

A newly listed British diagnostics biz, aiming to become a leader in the relatively nascent DTC market for IVD products.

All powered by #AVCT
@AvactaDx
's Affimer platform.

A highly compelling investment!”

Just an observation, but I see Vatic posted on LinkedIn yesterday with a Lab Technician vacancy. Can’t be too worried about prospects if they’re taking on more cost.

Agile Life Sciences, trading as Agiletestservices.com, is powered by Saturn Pass (an M19 sister company), and was set up by Peter Whitehurst at around the same time as he set up M19 Life Sciences Ltd. Two observations here;

1. Why would a guy with a very successful career history ditch it all in 2020 to set up brand new businesses?
2. Why were Agile, a fledgling business with no trading history, invited to a round table meeting on 11 May 2021 with Lord Bethell to discuss upcoming test validation legislation, alongside the likes of Roche, Abbott, Randox etc? https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/1027379/Q1_2021_Ministers_Meetings.csv/preview

Sorry but he was talking ******.

Acon Flowflex, Orientgene/Healgen and Innova are all made in China. The only U.K. manufactured test the NHS uses is from Surescreen in Derby (anyone seen those in the local chemist or had them through the door??!). For anyone interested, Neale Hanvey MP is discussing all of this in an adjournment debate in parliament tonight. It’s the last order of business and could start anywhere between 10 and 11pm.

But yes, if AffiDx could get through the CTDA process then the U.K. market could be massive. The backlogs in that process will I’m sure come up in the debate later. Personally I think other markets are where M19 are going.

AVCT investors (of which I’m one) are perplexed at the lack of M19 marketing post HUA. Personally I wonder if a nice juicy announcement in that respect is being tied in with a potential RTO announcement here - it would certainly help any placement at a premium, which some have mooted as a real possibility.

All guesswork, but I guess that’s the fun of investing!

In May LSAI raised 3.85m in cash “despite the current relevant strength of our working capital position”. So that raise significantly boosted cash.

In June LSAI announced that following a review it had been agreed that steps needed to be taken to reduce operating costs. Nothing was said about having to bolster cash reserves further.

Despite this, in October they sold the insights dashboard and said “ On 21 June 2021, the Company announced that following a business review the Board decided it was important to reduce the Company's operating costs and bolster its cash reserves.”

Doesn’t it seem odd to sell assets on the basis of having to boost cash reserves when just a few months earlier they raised £3.85m, and their own review in June said nothing about having to boost reserves further. Seems more likely to me that the purpose of the sale was actually to begin realisation of existing business assets for outgoing Directors and move towards a non trading cash shell position.

Just to add, if there is an RTO then that puts us firmly in bed with Avacta beyond Covid, and Avacta have very exciting tech in Affimers which will extend to many more diagnostic tests needing global distribution.

Don’t know why, but share your irritation!

To be honest, there doesn’t appear to be much to look forward to in the TU. Business was hit by Covid (which is still v much with us) and customers have become wary of using us post the defamation claims (unfounded they may be, but mud sticks). In the meantime we’ve sold assets and given notice to the legacy Directors. So, we may have cut more costs and rationalised, but I can’t see there being much good news on sales.

So why did the boohoo boys et al invest, and so aggressively in their favour, in May?Well in around that time another of their companies, M19 (a private company), started work to achieve HUA for AffiDx - that has now been achieved and is a first for a U.K. company. The potential revenues from that product globally far outweigh LSAI existing potential. Problem is, M19 stock is illiquid so shareholders would be unable to crystallise gains. Answer, buy a PLC on its knees, sell assets down to arrive at a shell, kick all legacy Directors out, and reverse M19 in when M19 really starts to gain value from sales. It would certainly be a way of rewarding the guy at M19 whose drove the HUA work, (Stephenson) who has nothing but a background in Healthcare and sticks out like a sore thumb on the concert party list!

Perhaps something we might get in the TU is a NED, an appointment which is now overdue. If that NED has any links whatsoever to M19 then, imho, the trajectory of LSAI will be more certain and we will be looking at a listed global distributor of medical devices rather than a location science business.

Just my thoughts, and needless to say, lots of uncertainty!

Do we really think M19 worked for months to get HUA, only to then ask “so what do we do now”. I don’t.

No more than an observation, but I see that one Nick Major, Technical Director at Sekisui Diagnostics, commented on a David Wilson LinkedIn post re HUA approval. He is also endorsed by David Wilson.

Sekisui Diagnostics - “ Headquartered in Burlington, MA, for 40 years SEKISUI Diagnostics has been committed to helping improve the lives of patients by providing innovative medical diagnostics to physicians and laboratories. We continue to invest in the areas of diabetes, infectious disease, coagulation, diagnostic enzymes and automated systems, and have a leading position as a provider of rapid tests in the US and high throughput coagulation systems in Japan.
Our workforce spans six sites located in four countries. We are a sister company to SEKISUI Medical in Japan, making us a worldwide company with R&D and Manufacturing facilities on three continents.
We develop, manufacture, and supply billions of tests each year to the global healthcare market through our commercial networks and partners. Our product lines include:
• Clinical chemistry reagents
• Coagulation reagents
• Point-of-care rapid tests and immunoassay system
• Enzymes and specialty biochemicals ”

Most likely nothing…

Posting for info, because I’d not seen it.

https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/1004232/Impact-assessment-validating-COVID-19-tests-in-the-private-market.pdf

Whatever people’s views on the Covid LFT (I remain v positive BTW), the longer term effect of the pandemic has been to pull forward things we might only have seen in the next 5-10 years - few knew about LFTs pre pandemic but they are now part of the public psyche and are likely to become more widely available across a range of diseases as time moves on and as people take more control of their own health supported by digital platforms (like Saturn Pass) linked to national health networks.

And Affimers have been shown to work beautifully in LFTs…

Maybe this is why Mina recently left Harvard to become the CTO at eMed.

“eMed is democratizing healthcare with a digital point-of-care platform that provides fast, easy and affordable at-home healthcare testing, supervised and guided online by eMed Certified Guides. We embrace quantitative medicine to deliver prescribed tests and treatments directly to patients, driving better and more cost-effective results. Visit eMed.com for more information.”

Re Bell ineptitude, this was him in Nov 20

Interviewer - “Do we now say with confidence that life should be returning to normal by Spring?”

Bell - “Yes. Yes. Yes. I’m probably the first guy to say that, but I will say that with some confidence”.

https://www.bbc.co.uk/news/av/uk-54878908