Member Info for Mars1

Apple tree did any of those companies have EU approval, can U.K. legislation override an agreement with the EU, basically what your saying is we agree legislation and passport for goods with you but we can change the goalposts by introducing new legislation. My own view would be that CDTA cannot override such arrangement.

Means of course the DAM clinic contract in the U.K. kicks in back in November it was 200000 tests a month it will be more now.

U.K. regs apply if you apply in the U.K. and EU regs only last til June next year, U.K. application will be necessary hence the reason why a self test application will have to be made. Disappointing Jag did not point this out in the RNS

Huge news ce mark in Europe allows self test sells in Uk

Guidance
Regulating medical devices in the UK
What you need to do to place a medical device on the Great Britain, Northern Ireland and European Union (EU) markets.
Approval in U.K. to June 2023

This is huge news the U.K. recognises EU CE Mark as ability to sell in U.K.
“certificates issued by EU-recognised Notified Bodies will continue to be valid for the Great Britain market until 30 June 2023”

PD has taken 5 months to request extra field data, why? They set the application requirements with a fee. They should have requested the data that they failed to ask for in 20 days. We know the Visitect test is one of the most independently tested tests around, because of Mologic and OFX, FIND confirms this. The data they are asking for is with a 3rd party ie field data so it is dependent on them responding. Odd the response has a deadline. Wonder why when it has taken so long to request it.

There is a difference between professional and self test so it is likely self test will not be exclusive but what is interesting the wording would have had DAMs approval prior to release as a named party. It is likely DAM want a U.K. supplier that has capacity that they can depend upon to provide a constant supply. Perfect bedfellows. By the way CKs work.

This is from the RNS dated 1st Nov, where further possibilities with DAM were forecast;
“ a recent 2021 study by FIND Diagnostics1, a leading testing authority in Geneva, Switzerland, found the VISITECT® test delivered results of 100% in specificity and 96.4% in sensitivity. Under the agreement, DAM Health agrees to exclusively use, sell and promote Omega's test throughout its network of over 100 clinics in the UK and Europe. DAM Health is currently using approximately 200,000 in-clinic COVID tests per month.



Whilst the initial agreement centers around the VISITECT® professional Antigen LFTs, there is the possibility to broaden the partnership to include Omega's VISITECT® antigen self-test LFT (once approved) and for DAM Health to sell Omega's Food Detective product throughout its network. There is also provision to extend this relationship beyond Europe, as DAM Health expand their international network of clinics globally. A further update will be provided on this in due course.”

Oh yes forgot we had NXP001 as well that also still has potential in other areas although no longer a priority for the new business development bod.

Thought we had just become phase 1 ready with the latest results, maybe that added experience (despite being short term) helped put the data package in the correct shape

Does that indicate the durability data has been received?

NFX description in RNS now extended to include ;
“ Nuformix has an early-stage pipeline of preclinical and Phase I-ready assets with potential for significant value and early licensing opportunities.”

LFT market estimated to be $13/14bn by 2030, currently $8bn, this will not go away, we have to learn to live with it.

Way it looks to me basic economic theory is not being applied demand is greater

https://pbs.twimg.com/media/FJkgM4AXEAUH2Qp?format=jpg&name=large

There is a tweet saying there are 5 scientific advisors reviewing 21 LFT applications for CDTA rules. 20 day review taking 4 months. Also reviewing tests that have already provided evidence of independent review. Are they too frightened to pass the tests. The whole country is now used to self test.

Wacca In addition to Soups reply it is also in line with the recent deals for IPF drugs so brokers valuation is based on previous market events

Soup thanks for detailed numbers that all makes sense, I was thinking along the lines, NXP002 has a potential value of $360m (not sure if that is total or capital cost only without royalties). Then we have NXP004. Either the products can be liscensed separately or a NFX could be sold avoiding royalty payments (although some pension funds do buy royalty shells for the ongoing guaranteed income). So if it comes to the crunch where will Lanstead sit will they be happy with 50cents which only covers NXP002 or will they hold out for more. I suppose it will depend whether they have potential better returns for their capital elsewhere and whether they introduced a buyer

Anyone with a view, are they aligned with the large holders and the bod to get fair value for the assets or is it their policy to align with a buyer for a discounted quick buck. Whatever their stance they will be a player in a bid.