"WRONG
ODX test cant be sold to DHSC as it didn't pass Porton Down as its the Mologic test."!
What on Earth are you on about? Porton Down is irrelevant.
You clearly have no understanding of the legal requirements.
Wessley...
I suggest you try reading what the CTDA Regulations actually say.
Not all tests will require separate approval. As per regulation 34B, the CTDA requirements in Regulation 34A will not apply to:
" 1. ... a coronavirus test device that is placed on the market or put into service only for use by—
(a)the Secretary of State;
(b)a devolved public health body; or
(c)a health service body supplied pursuant to an existing contract.
2. ... a coronavirus test device that is supplied to—
(a)the Secretary of State;
(b)a devolved public health body; or
(c)a health service body pursuant to an existing contract."
Therefore, the CTDA requirements will not apply to those tests that may be provided under the terms of ODX's Contract with DHSC (whether professional POC or home use).
Moreover, Regulation 34C says:
"(1) The requirements in regulation 34A do not apply in respect of any period before 1st September 2021."
This means that any test which met the requirements for CE marking and which obtained marketing authorisation on or before 31 August 2021 will not be affected. These will primarily be professional POC tests - including those that will be supplied to DAM Health by ODX under the current Heads of Terms announced yesterday.
Basically, the CTDA requirements will only apply to tests that had not received marketing approval prior to 1 September - whether professional POC or home use. There are some transitional provisions in relation to the period of 1 September - 31 October outlined in Regulation 34C but they're not really relevant to ODX (although they clearly were to NCYT and Avacta).
DHSC has published the names of the first batch of tests to be processed and approved under the CTDA. They've also published a list of tests that have been given further derogations/exemptions - these are primarily tests that have not completed the standard CE marking and market authorisation process, but that were given EUA.
At present, there is nothing to stop ODX providing their professional POC tests in the UK. As and when they may get HUA in the EU, then they will need to apply under the CTDA but that will relatively straightforward.
There's no need for ODX to RNS anything at this time.
"Twatcher - didn't think i would be saying this - as many know I have been a long term supporter of this stock.
However you are correct, and the facts are the facts."
TWATcher wouldn't know a fact if if bit him in the @r$e...
I think it's rather pathetic that the usual suspects are trying to suggest that somehow ODX has missed the ball on the new MHRA requirements. One thing we know is that CK and the team are all over it when it comes to regulatory requirements.
ODX will need to register the Visitect test. What they don't need to do is RNS the fact that they have done so, as this is simply a 'business as usual' process.
Avacta and NCYT have RNSed as questions were raised and, frankly, they haven't had a positive RNS in a while.
Unfortunately, this seems to have fired up the bottom feeding trolls on here, as attested by the sea of green boxes. Just ignore them.
"Trolls are buying in with their life savings?"
*Snork*
You owe me a new keyboard - this one's covered in coffee... ;-)
Probably just balancing trades from brokers and MMs.
The various pharmacies near me have nothing under late November/early December.
The hospital got a supply but it was unfortunately whilst I was in isolation with Covid - and they're now waiting for another batch.
Some areas seem to have a plentiful supply, some are short of one or both of the vaccines (there are different vaccines for different age groups). If I was over 80 - no problem, I could get one tomorrow...
I've managed to book a Covid booster jab for this Wednesday, 29 days after testing positive.
Still having no luck trying to find a 'flu jab though. Seems to be shortages again.
FOMO later today should be interesting...
"Seems DAM have sites in the UK and Spain so a reasonable exclusivity grant without giving away all of Europe...
...Having said that DAM have enough sites to be considered well established and interestingly the major British tourism spots in Spain are covered."
Mexico as well.
Scratch my last post... you're right. The exclusivity is mutual:
"Under the agreement, Omega will exclusively supply its VISITECT® professional use COVID-19 Antigen tests ("LFT") to DAM Health's clinics throughout the UK and Europe. "
"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."
This is big. The professional POC test was always going to be the hardest to commercialise. This has done it.
And we still have the self test (once HUA arrives) - and that's going to be the easier of the tests to comercialise...
"In this particular industry you don't tend to give up exclusivity without the distributor agreeing to minimum orders be that per month, fq, or year. Hopefully this is the case here. Nice shot to the arm either way."
I'm not sure that ODX have given up exclusivity. I read the RNS as DAM agreeing to exclusively use the Visitect Professional POC test.
I assume that Cakeslice is another of the 'noms de plume' used by the Trollmeister. It fits the food related theme...
It'll bounce around a bit this morning as the day traders sell into the rise.
"Great post comouter farce, from start to finish. Cop26 start Monday canny believe that's no sales and, not even approval and no visitect sales where ae they. Elephant in the room.
Aim shares need news and there gunna be tons of news around green energy with cop26 here this is dying a slow death what price isnthe test anyway. Odx are not getting 374m not a hope in hell. No ii on board, directors sold, no sales"
Do you want to try that in comprehensible English?
"26May2022 has been set in stone as the IVDR go live date for many years. I wouldnt bank on it occurring though as there is a proposal to delay implementation for 3 to 5 years (for current on market products certified under IVDD) as labs and manufacturers are not ready to implement the change.
For example currently around 8 percent of IVD products require review by a notified body before they csn be placed to market with the rest allowing self certification for CE marking.
Under IVDR the estimate is 80 to 90 percent of products requiring this. As a high risk medical device you can guarantee COVID tests wpuld sit in this bracket.
In summary you don't want IVDR yet as it will likely kill or greatly hamper smaller companies who aren't as regulatory experienced."
You and your informed insights....
;-)
"Does anyone recognise what all the icons mean in the bottom right of the Antigen tests box? (To the left of the CE mark.)"
They're icons/pictograms identifying that the box contains IVDs, not to be reused, giving instructions on storage etc. They're part of the ISO labelling system and a requirement under the new EU regulations.
It's just the listing of the devices that have been CE marked and registered with the MHRA for marketing purposes. You can do a similar search for ODX or any other medical device manufacturer.
"I'm not vaccinated, my reasoning was that after I caught Covid last October, I was of the opinion that I had the antibodies to fight of a reinfection so why have a vaccine..."
Because any antibodies wane over time. Having Covid doesn't protect you from future reinfection.
"...which to be honest doesn't offer the same protection as natural infection."
I'd be interested in your clinical evidence for that claim.
Vaccines provide you with a level of protection but without the significant risks that you run by getting Covid itself. We're only now beginning to uncover the long term impacts of Covid infection - even in those with relatively mild symptoms.
"The govt have no commitment to pay a penny."
I suggest you read the Contract again. The government does have certain obligations with respect to committed spending (and has actually paid up on them).