Member Info for Muck165

Have had this reply from Bioserv just now;

“Good Morning

I’m not sure if we are expecting more. I will have a clearer answer on Tuesday after the festive season.

Thank you
Rostand”

@bella - I emailed them yesterday to ask exactly that. Will post again once I hear back.

Blimey! Worldometer is currently showing 466k US cases today, with 11 states yet to report.

Yep, and I was just able to order some through the Bioserv site with no warnings about stock or delivery issues. But the email reply is, nevertheless, what I got this PM.

I’ve been having correspondence with Bioserv about a bulk order for my business. Earlier today I emailed to say I was still interested in AffiDx but asked if they had any further details about the actual S&S for Omicron. This is the reply I got at 15.49

“Dear xxxx

I’m very sorry to say this but we don’t have the AffiDx anymore.

We do have the Healgen tests and are running low by the hour.

Please let me know very soon what you think.

Best Regards

Rostand Peka
Bioserv”

Guesses anyone? Perhaps they’ve now actually stopped sales pending CTDA, or perhaps they’ve sold out and can’t get more because stock has been re-directed (HMG/M19?)

Agree Pedro

Always useful to look at time lines…

Hughes/Kamani invest in Avacta early 2020
They shortly then set upM19, and get exclusive B2C rights, and non exclusive B2B rights to the Avacta test.
M19 tried to get their own RSPT test away, but that seems to have failed, largely I think because it’s an antibody not an antigen test.
Then in April it seems Hughes and Kamani lumped more cash into M19 Healthcare (see charges registered at companies house)
In May they, with a concert group of family, Cheshire based investors, and notably Stephenson of M19, invest in LSAI, a business on its knees, ostensibly to drive the existing business. But shortly thereafter they give notice to the 2 remaining legacy Directors (promising to ensure they benefit from the EXISTING business), and begin to sell down assets.
From June/July onwards M19 is like tumbleweed on social media..weird for sales and marketing experts. We now know that in this period their focus has been getting HUA for AffiDx, building Saturn Pass, and potentially also Agile.
They trademarked Meduflow in November, but despite the HUA appear to have done next to nothing to promote it. Perhaps they don’t need to because of deals going on behind the scenes?
Whatever, I’m convinced that there was zero reason for the concert party to buy into LSAI unless it was M19 linked, and the fact LSAI has £20m of prior trading losses to use may well have been a primary driver.

Long term AVCT investor here who has had a bit of a punt in here today. Why?

- as has been noted, new significant shareholders include all those behind M19. Of particular note for me is Christian Stephenson; not the largest shareholder in the concert party by any means, but he is the Chief Development Officer of M19, has for me has been the driving force behind M19 growth, and a RTO here would now would offer him significant reward for that work.
- the investment through the placing in May occurred at the same time as another M19 linked company, Agile Life Sciences, trading as agiletestservices.com, met with Lord Bethell alongside the likes of Roche and Abbott. Agile have grown significantly since incorporation last year and appear to be launching LFT services next week. May was also around the same time that M19 blacked out it’s social media (June/July).
- of course, M19 have just secured HUA for the Avacta test, the first such CE mark for a U.K. developed test. That opens a considerable market for those that know how to sell products…..boohoo!!
- there is also a real prospect of gaining FDA EUA for the test.

To be honest, I’m struggling to understand why Hughes and Kamani would put themselves, family, close associates and M19 drivers into LSAI unless there was an ulterior motive. For me a RTO involving M19/Saturn Pass/potentially Agile seems entirely credible, hence my “punt” investment.

GLA

Potentially Poirot - notice they all invested, along with other concert party members, in May, just before M19 went dead on social media and the same time Bethell met Agile. Also notice the associated RNS expressly states that the concert party aren’t precluded from taking over the company. It’s intriguing, just wary of a P&D..

Not in LSAI, but have seen the talk on Twitter about Hughes/Kamani and the possibility of a RTO involving M19 and/or Saturn Pass. Not sure about it myself but wonder if others have views…?

Had a look at the Vatic site today, having not looked for a little while, and noticed a few things… https://www.vatic.health/

1. There is now a bar at the top highlighting that you’ve accessed the U.K./EU site, and providing a link to their US site.

2. The FAQs have been expanded considerably, and specifically compare Knownow with the Abbott Binax test (the most widely used test in the US).

3. The US state is pretty sparse, but does confirm they have a US company, Vatic Inc based in Delaware.

Just interesting I think to see all these US connections. Apologies if previously posted/highlighted

Thanks Mr A! Desertrader, we can now add this to the list EUA granted 24/12.

95.3/100 nasal. Doesn’t say to what CT. In this case accelerated review owing to Radx/NIH support

https://www.myscience.org/en/news/wire/roche_covid_19_home_test_granted_fda_emergency_use_authorization_expand_access_rapid_self_testing-2021-roche

Worth also noting the FDA EUA priority workflows - see page 7 and Appendix A of https://www.fda.gov/media/135659/download

Basically, if a test is supported by Radx or NIH then it gets a priority review. Apologies if previously posted.

Sorry, the links don’t work. But for info, the first was a download of current FDA policy published 15/11, and the second a download of the current home use Ag template.

FDA are prioritising home tests from developers with manufacturing capacity of more than 500,000 p/w (see p7 of https://www.fda.gov/media/135659/download).

Interestingly it seems they’ve also changed the home use template, and now say that a usability study might not be needed if it can be shown that the test design and instructions are similar to a previously authorised home use test (see section 7 of https://www.fda.gov/media/140615/download).

I had thought the previous usability requirements were a bit of a barrier for us, particularly given the FDA’s rather rigid insistence that they be conducted on US soil, but the change in the template potentially gets over that problem I think. Is it too much to hope that with our HUA CE mark, our manufacturing capacity, and the drastic shortage of LFTs in the US, that FDA EUA is more of a possibility now??

Interesting to see this EUA granted 24/12

“The FDA’s EUA decision stems from Roche’s participation in the National Institutes of Health (NIH) Rapid Acceleration of Diagnostics- (RADx) Independent Test Assessment Program (ITAP), which aims to accelerate the regulatory review and availability of high-quality, accurate and reliable OTC tests to the American public. The COVID-19 At-Home Test was prioritised by the FDA based on Roche and SD Biosensor’s ability to deliver large quantities of high-quality tests and ramp up manufacturing to meet future demands.”

https://www.myscience.org/en/news/wire/roche_covid_19_home_test_granted_fda_emergency_use_authorization_expand_access_rapid_self_testing-2021-roche

https://mologic.co.uk/mologics-covid-19-rapid-antigen-self-test-selected-by-nih-for-radx-initiative-funding/

Couldn’t agree more. We will people taking more control over their own health through at home testing supported by digitised platforms linked to the NHS.

Michael Mina seems to share the same view, having recently left Harvard to become the CSO at https://www.emed.com/. This is also the Vatic vision….

I’d only add that I do think M19 have been doing a lot behind the scenes to maximise distribution, not least with Agiletestservices.com. That is a company set up last year by a guy with a lot of M19 connections - they are close to becoming an approved LFT travel testing provider,are powered by Saturn Pass, an M19 sister company, and met with Bethell in May to discuss the new LFT legislation alongside the likes of Roche and Abbott.

If LFT’s come to the fore again for travel testing, and Agile have ready access to a private HUA test, then I think they will need lots of them. Remember, free govt tests won’t be around forever…

And we make them.

Sorry, meant to say “Avct distributor not “our” distributor

Just my understanding…

There is one Avacta test.
We are making it
GAD are making it
It has HUA
M19 have exclusive global license to distribute B2C - they have chosen to brand it for that purpose as Meduflow
AVCT can distribute B2B, presumably as AffiDx.
Other distributors may come on board for B2B. They could stay with “AffiDx” or brand it themselves.

THE SIC code at companies house for both M19 Ltd (our distributor) and M19 Healthcare shows both as manufacturers of medical devices. But I’d be surprised if either is making the Avacta test because I would have expected Avacta to RNS them as a contract manufacturing partner (as they did with GAD and ABDX) - -they haven’t.

Like I say, just my understanding.