Member Info for Muck165

Agree MB - could be a nice opportunity for next years ISA allowance!

Here’s some other potential ABDX jobs listed just in the last couple of weeks by Cubed

https://jobs.cubedresourcing.co.uk/vacancies/2045/production--assembly-operatives.html

https://jobs.cubedresourcing.co.uk/vacancies/2221/project-manager-it-bias.html

https://jobs.cubedresourcing.co.uk/vacancies/2245/weekends-production--assembly-operatives.html

https://jobs.cubedresourcing.co.uk/vacancies/2063/manufacturing-scheduler.html

If this is all ABDX, and I think it’s a very good chance it is, then we are increasing manufacturing, warehousing and logistics capabilities. Doesn’t sound like a company who won’t be making/selling much!

Forgot to finish the first sentence! - really just meant to highlight that ABDX say PCRD is perfect for Covid diagnostics

GLR - this looks like a lovely find to me, particularly given the statement ABDX make on their site that

I notice that Twist Biosciences recently got an Eua for a sars cov2 NGS test - https://www.fda.gov/media/146932/download.

I’ve been trying to read up to see if the PRCD might have some link to this. I don’t think it does, but I am pretty ignorant on the science and wonder if you have any idea?

It’s always interesting to look at the jobs on offer!

The ABDX site currently lists two vacancies, both for sales managers based in the US. Couple that with the recent additions to their site targeting the US and it’s plain to see that geography is a focus for them. Worth noting as well that the FDA very recently issued an EUA to Beckman Coulter for a serology LFT, which demonstrates that tests like Abc19 are an FDA priority.

I also noticed that people from Cubed Talent Mgmt were liking recent ABDX LinkedIn posts. They’re based in Yorkshire and posted this vacancy today;

https://jobs.cubedresourcing.co.uk/vacancies/2082/warehouse--flt-operative.html

It doesn’t name ABDX, but they do say; “ Our client is an innovative technology-led company focused on producing diagnostic testing kits. They develop, manufacture and distribute rapid testing devices for a range of medical, veterinary and engineering applications.” The job roles (which are based in York) are described as

-Helping to set up and maintain the newly acquired warehouse space
-Using SAGE to manage goods in, goods out and raise POs
-Manage internal material receipt forms and goods in documents
-Accurately pick orders and pack finished products to a high quality
-Communicate with suppliers, customers and internal departments
-Manage stock control, data entry, loading and unloading deliveries
-Operate the FLT to unload deliveries etc.

I reckon this is ABDX. If so then they’ve clearly just acquired new warehousing space. That’s unsurprising since we know they been stockpiling ABC-19. But you only need people to do everything in the job spec if you are SELLING the stock, or are very shortly expecting to.

I’ll start - presentation tomorrow will be a read through of the interims, much focus on regulatory frustrations, an “I can’t tell you much” re the potential MoH deal, some technical explanation re the POC delay. Questions will centre on lack of sales, which will be blamed on lack of FDA approval.

I am hoping the placement rumours will be put to bed.

Your turn

Just to add, our test works on 3 widely distributed PCR platforms. Add in the Biomek, and we also automate the entire extraction and pippetting work that labs normally need to do manually. Add into that the 10,000+ a day tests we can make and, voila!

Yep Tricky - from everything I’ve read on this the FDA are placing focus on home testing/sample collection, and high throughput tests that can be manufactured in large quantities and don’t place too much strain on the underlying consumables supply. Going further, they naturally want to get to those tests which are already being distributed looked at ASAP.

So we seem to be a priority solution on a priority list.

We notified the FDA of our intent to distribute our test in the US pending EUA approval/review, in accordance with the rules set out in section C of this (pages 12-14) - https://www.fda.gov/media/135659/download.

There is a list of other test manufacturers that have done the same here - https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/notifications-and-emergency-use-authorizations-faqs-testing-sars-cov-2, (just open the 4th question to access the list).

The list, last updated on 16/3, has 91 companies, 65 of which are still waiting for EUA. Of note is that BC (ref their own antigen test) are one of these. In their virtual town hall series the FDA have said that they are looking to get to the applications made by the companies “as soon as possible” see page 8 of https://www.fda.gov/media/146615/download. They are also clear that high throughput tests remain a priority.

So it seems to me that;

1.There are a limited number of companies who have notified pending EUA.
2.Because we are already distributing, we are likely to get bumped up the list.
3.We should therefore get an EUA decision more quickly than anyone making new non priority eua requests, or anyone with an existing EUA application who is not already distributing.

ADVFN level 2 is showing 10m volume today, so LSE are c 5.7m short

What were people expecting?

We already knew there were no large orders or approvals.

The cash position seems strong, so can’t see a placing happening.

POC delay is disappointing I admit.

Agree AJ - it is inconceivable to me that Abingdon won’t make hay in the current environment, and with its very low free float, lock ins, comparatively low mcap etc I can see the sp jumping on any positive news.

All true AJ, but we should add in;

Sona is currently NP swab sampling only - U.K. gov has been very clear it doesn’t want that.
Sona test got deprioritised by the FDA and withdrew its health Canada application pending new trials, which as far as I can see it is yet to find a sponsor for.
We appear to have received no manufacturing orders from our international partner.
Sona are developing a saliva version, but to date there is no data on that and they are still looking to commence wider trials
Yesterday Sona laid the grounds for a $20m placing by issuing a shelf prospectus. Some might say that’s because something “big” is brewing that they need funding for, but I expect their price to tank today.

All in, I think we are linked with Sona but I definitely do not think they will be our gravy train.

Maybe - note that FDA have literally just updated their EUAs and we aren’t listed.

https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/in-vitro-diagnostics-euas#individual-molecular

So true!

Just for reference here’s the GDR and Ncyt registration links

Gdr - https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfrl/rl.cfm?lid=703727&lpcd=QLT

Ncyt - https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfrl/rl.cfm?lid=688533&lpcd=QJR

It’s interesting to follow the product code links and compare. I agree this is a step in the whole process and is likely needed to allow imports of medical devices into the US, so may not tell us much.

So I see, but I notice they also have training videos which I don’t recall seeing before (although I may be wrong!)

I am being offered more to sell the stock on HL than to buy it!

Why?

I’ve added this...

What is the Genedrive profit margin on sales achieved through each of its distribution partners, particularly Beckman Coulter?