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Completely agree.
Post Covid the light has really been shone on LFT potential across a whole host of varied and lucrative applications, and there has been an acceleration in LFT tech, and test bio marker developers wanting to use it. It was a great move for us to transition into a CRO/CDMO to become true experts in that field and be one of few able to help all those developers. We have some great things in the pipeline, the real issue being treacle like regulatory processes delaying approvals and, therefore, mass manufacturing contracts.
But those approvals and manufacturing contracts will come in time, and the new IDAP scheme will accelerate that.
As it stands, we’ve rebuilt the foundations, planted lots seeds, are at a stupidly low SP with heavily aligned directors, a low free float, and are just waiting for everything to blossom. It might be boring at the mo but with some patience this will flourish imo.
Have been looking at 52 North again.
-Received the first-ever investment for Macmillan’s new £3.5m Innovation Impact investment portfolio.
-MedTech Company of the Year' in the 2023 Cambridge Independent Science and Technology Awards
-Now part of the IDAP pathway (which seems really significant to me)
As far as we are concerned, I notice they’re currently recruiting for a VICE PRESIDENT, TECHNOLOGY (IN VITRO DIAGNOSTICS), whose job description includes;
“Manage our partnership with a leading CRO, ensuring alignment with our development goals and timelines.”
“Lead coordination with the CRO for clinical trials, regulatory submissions, and other critical processes.”
We are that CRO. So they are recruiting to boost engagement with us.
https://salutemyjob.com/jobs/vice-president-technology-in-vitro-diagnostics-cambridge-cambridgeshire/1236396301-2/
On a broader point, the new IDAP pathway appears to be a U.K. govt initiative to identify breakthrough technologies and to accelerate access by breaking free of European medical device regulations that are clogging up the whole system and causing delays. If the current pilot scheme works then it could open up significant opportunities for us beyond the 2 companies were helping in the pilot.
This is well worth a read I think;
https://www.gov.uk/government/publications/the-innovative-devices-access-pathway-idap/the-innovative-devices-access-pathway-idap-pilot-phase
It sets out details about the new govt innovative devices access pathway, inc its aims, eligibility criteria, and benefits. Of note for me were;
-multiple govt agency support to progress products quickly to mkt.
-Fast track review
-The potential for “exceptional use” authorisation from MHRA.
-The criteria for getting into the scheme included; “ The use of the device in the healthcare system has the potential to be transformative” and “ The product will provide system wide benefit and be widely adopted”.
In a nutshell, this is a multi govt agency scheme to support devices with the most potential to deliver transformative outcomes across our national health service.
8 were selected. We are working with 2 of them. Fair chance we could therefore soon be making 2 tests widely in use within the NHS.
Have you seen something Ant? The only thing I saw is that Loops CTO is having an interview shortly with a Spanish Biotec organisation to discuss the problems with the Notified Body regime under new regulations, and the delays it’s causing in getting approvals.
Just for awareness, but Salistick is now available through Apoteket (the largest pharmacy chain in Sweden). Its branded as coming from Addeira, who have rights to distribute it in the Nordic region just like we have the rights in the UK and Ireland, but unlike us they have no part in its manufacture.
Its also available through SuperPharm in Israel, again their largest pharmacy chain.
The point being that sales, wherever they may be, are likely to have an impact on our bottom line because we are making elements of the test for whoever sells it.
JP - just with reference to your first post in this thread, in my experience companies like to give themselves headroom equivalent to roughly 25% of shares in issue each year, and they typically ensure this with standing agenda items at AGM's.
We didn't do it at the AGM, we are doing it now, and the 2.7m we are asking for is roughly 25% of the shares in issue.
All routine stuff imo.
That’s what I was thinking. Another ignorant question (!), but if the shares were issued without authority in December, could they be lawfully traded until the issue was ratified (even though admitted to the exchange)?
If yes, then what happens if shareholders refused to ratify?
If no, then it might explain the dump of stock today post the GM.
We’re getting somewhere! That’s precisely my point.
We issued 1,375,000,000 shares which were apparently admitted to trading in 19/12.
Resolution 1 at the GM was table to RATIFY that issue of stock.. Resolution 2 was tabled in respect of the warrants linked to that issue. The subsequent resolution relating to headroom was only added to the GM agenda later.
I am just trying to understand why a share issue apparently done in December needed ratification in a GM now.
Gordon, resolution 1 read
Resolution 1 - Ratification of issue of Placement Shares to clients of Novum Securities Limited
To consider and, if thought fit, to pass the following resolution as an Ordinary Resolution:
"That Shareholders ratify the issue of 1,375,000,000 new fully paid ordinary shares by the Company on the terms and conditions in the Explanatory Memorandum."
Resolution 2 related to the warrants. Neither related to the headroom, which was the new addendum to the agenda.
That's certainly an understandable position - Yates is well aware shareholders are frustrated by the lack of transparency yet seems to do little to address it. But personally I will be adding more when funds allow because this does seem to me to be a tanker that is turning and now moving in the right direction, with far more positives than negatives as far as I can see.
New survey published a couple of days ago
https://www.news-medical.net/news/20240213/UK-patients-want-better-access-to-early-and-accurate-diagnostic-tests-survey-shows.aspx
Https://www.med-technews.com/news/medical-device-news/government-announces-%C2%A310m-to-help-eight-companies-bring-inno/
Confirms the ten companies given money by the NHS. It includes Upfront, as per my previous posts, but also 52 North which we are helping with their Neutropenia test.
It seems to me that there is an imbalance between test developers and CDMO's like us, which the developers need to advance their tests through to commercialisation, which means we get to pick and choose those we want to work with. The fact that 2 of our partners are just a select few receiving govt funding suggests we are choosing well.
Https://www.linkedin.com/posts/gonzalo-ladreda-06a903b8_healthcareinnovation-publicfunding-bbclookeast-activity-7163814784075829248-PWbg?utm_source=share&utm_medium=member_desktop
High hopes for this one....
For anyone interested
https://www.selanoil.com/wp-content/uploads/2024/02/Regulation-30-Announcement.pdf
Agree - good post.
An ignorant question I know, but is there much involved in getting GOI approval/consent, and will it help at all that Selan got GOI approval iro what looks to me to be a similar transaction just 2 months ago?
https://www.selanoil.com/wp-content/uploads/2024/01/Disclosure-under-Regulation-30.pdf
well i got caught a little too because i use advfn l2 and they posted the wrong rns (it was a previous update rns) so i top sliced only to wonder why the price then rocketed! as it’s panned out i needn’t have been worried, but i was ****ed at the time!