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Did that make you feel happy Ant? Oh dear.
Well if Labour do get elected they will do something for the mentally unstable such as yourself..
It's very likely to be called tonight. A Labour government will be great for retail investors. They say they want to attract investors. They aren't corrupt and they will give the FCA more power to deal with poor practice imho. They are especially keen on prevention and early intervention in health. Might even see trials and regulatory approval speeded up because they have a commitment to get the best tests, treatment and drugs in place.
GLA.
This is why Abingdon is so confident that they will be in profit this year, becoming self sustaining as a company. Alongside Salistic in Boots and Tesco's and sales of their iron defiency tests looks like they'll be up and running in 2024. Be nice if the 5 std tests got accredited this year too. All to play for. Thx for sharing Muck165.
Two little thing I did notice in the video;
- Each LVOne test actually comprises 2 LFT’s.
- They confirmed that their manufacturing partner, “based in York” has already made 20,000 “tests”, so 40,000 individual LFT’s.
So if this gets off the ground, and every indication is it will, then the manufacturing requirement will actually be double the “tests” sold.
Upfront posted this video to explain their history, product, and long collaboration with North East hospitals. 20 mins and worth a watch
https://www.youtube.com/watch?v=Tv1ls6QasiY
Well, the only new comment I can see is; “ Our next objective is to commence deliveries to our inaugural customers this summer.”
“Deliveries” might suggest they already have orders, and that would mean manufacturing by us.
There must be a reason?
Interesting to see they’ve only just put something out on this given they got UKCA in March!
We are thrilled to announce a significant milestone: Loop Diagnostics has received the UK-CA Mark certification as an In Vitro Diagnostic (IVD) for our SeptiLoop device, enabling its clinical use in the UK!
https://www.linkedin.com/posts/loopdx_ukcamark-septiloop-ivd-activity-7198646838399242240-rz0E?utm_source=share&utm_medium=member_desktop
Pleasure! So many good things to keep an eye on here.
FOFH still puzzles me though. It (nor Devyn) has any web presence as far as I can see and whilst STI diagnostics is a great market to be in because rates across a variety of infections and age groups are rising globally, “investing” £500k in a new (and what appears to be) one man band venture seems bizarre unless there is an angle somewhere. Just can’t think of the angle, unless it has something to do with our rights to offer the tests as own brand perhaps with Boots in mind, or wanting a US foothold.
Our investment would value FOFH at over £2m, being about 14 of our current MCAP. On the face of it that would seem foolish at this pre reg approval/commercialisation stage unless there is a nugget somewhere.
And Yates has never struck me as foolish.
The only other reason I can think of is that FOFH couldn’t pay us, so we took equity instead. But if that were the case I would have hoped for more than 23%.
Anyway, current things on my radar are outcomes from the latest Upfront and Loop funding rounds, Upfront UKCA approval, and of course the early July trading update.
Thanks for all your nuggets @muck .
They are not going unnoticed ;)
Nice post from 52 North, and so is the comment from the National Clinical Lead for Innovation at NHS England.
https://www.linkedin.com/posts/52north_spotlight-on-the-nhs-clinical-entrepreneur-activity-7198268800885026816-XGf3?utm_source=share&utm_medium=member_desktop
And a number of news outlets have picked it up. Here’s one example with lovely words like “groundbreaking” and “transformative”!
https://bioengineer.org/researchers-develop-game-changing-blood-test-for-stroke-detection/
Upfront just posted about their results
https://www.linkedin.com/posts/upfrontdiagnostics_exciting-news-alert-after-3-years-activity-7198219266465136640-hgsQ?utm_source=share&utm_medium=member_desktop
Ooh, like the sound of that Muck. Reckon there could be a pretty high chance as it's a market- disruptive product.
For anybody unaware, Boots is owned by Walgreen Boots Alliance Inc, which ranks #18 of the largest US companies by revenue and has over 9,000 stores across all 50 US states as well as internationally. So if Salistick were to get FDA approval then I think there’s a fair chance it will find its way into those stores, particularly given Boots are now selling it under its own brand.
May be wishful thinking I know!
And finally, just a real world story published by the BBC last week showing the real difference early diagnosis of LVO stroke can have to people, and the NHS.
https://www.bbc.co.uk/news/articles/c0kllj7knyxo
Just some things to remember on this;
- Strokes will cost the NHS £43bn next year, largely through ongoing care needs. Stroke is an NHS priority.
- The whole purpose of IDAP is to fast track transformative diagnostics into widespread NHS use.
- Upfront have been developing LVOne with heavy NHS collaboration for years, to make sure the product matches the customer.
-Upfront are expecting UKCA in H2 2024, ie by the end of June.
- we are the CDMO partner, and have made all batches so far. Very reasonable to think we will carry on doing so, particularly given that we currently have a lot of currently mothballed automated manufacturing capacity in Doncaster ready to go. If I recall, capacity is “millions of tests per month”.
- in recent funding pitches, Upfront have said they could price each test at £600 and it still remain cost effective to the customer. Reality is it will likely be £200 per test.
- there is global potential for this test subject to regulatory approvals (and of course we have now significantly bolstered our regulatory resource with IVDeology.). I do wonder if that acquisition was driven by the fact that we are likely to have a lot more developers reaching the regulatory stage of the whole CDMO process now.
A great and potentially highly lucrative customer for us.
LVOne US trial results were published in an official journal of the American Stroke Association on Friday.
https://www.ahajournals.org/doi/full/10.1161/SVIN.123.001304
Upfront posted a news article about it on their site yesterday
https://upfrontdiagnostics.com/us-clinical-trial-results-published-in-american-stroke-association-journal/
“ These outstanding results confirm previous findings from a clinical study performed in the UK by Upfront diagnostics in collaboration with Newcastle University and open the door for identification of LVO patients in the pre-hospital setting. Deployment of the blood biomarkers in the field could allow fast-tracking of patients to treatment with thrombectomy, halving the risk of disability and the healthcare/societal costs of stroke. Also, with these results, Upfront positions GFAP and D-dimer as the strongest candidates for identification of LVO patients in the pre-hospital setting.
Several doctors from different American departments of neurology and neurosurgery were involved in the study: Harvard Medical School, University of Alabama at Birmingham, Duke University School of Medicine, University of Puerto Rico School of Medicine, Massachusetts General Hospital, and Brigham and Women’s, St. Michael’s University of Toronto, UCLA Stroke Center and State University of New York at Buffalo’s Jacobs School.”
Add all this in to LVOne being 1 of just 8 devices on the IDAP scheme and you have to think we have a great customer here.
£8-9m on a rolling 12 month basis was what Yates said would be breakeven.
We did £2.4m in H1 so we’d need at least £5.6m in H2 to get there, which would be a 93% increase against our £2.9m in H2 last year. I certainly think that’s possible but in truth for me anything north of £4.75m would still be a cracking result.
During June, should see a gradual rise towards trading update early July. Hopefully we will have broken even?
All this positive news about would hope share will start moving northward soon,maybe towards at least 16p and beyond.
I’d just add that Stuart chose to sell to us, and for 100% paper. So he must regard us and our prospects pretty highly too.
Just for info but Stuart Angell, the founder of IVDeology (recently acquired by us) is the BIVDA Regulatory Affairs Programme Manager, as well as being Chair of its Regulatory Affairs working party and a member of its Executive Board.
He is also Chairing a session on the European Medical Devices Market, and presenting a session about placing IVD's on the UK market, at the Medtech summit this weekend in Brussels, an event billed as "The Flagship Regulatory Event of the Year". Yates and our head of sales and distribution are accompanying him.
The point I suppose is that by acquiring IVDeology we have secured the services of someone who appears to be a very highly regarded, influential and experienced regulatory expert. And lets face it, if you are a developer wanting regulatory advice about commercialising an IVD in the UK then BIVDA (and ergo Stuart) would be the first place to start looking.