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Its an advert for DAM, it is not an advert for DAM using visitect.

Dam has scores of clinics operating in the UK. They aren't turning people away from the door since the 1st of Nov, and will continue to operate with their existing LFT suppliers until the visitect gets CTDA sign-off.

"This is the first test to be designed, approved and manufactured in the UK "
Except of course it currently isn't approved.

Anyhow hasn't lansdown heard of Surescreen ?

people either done bother to read, or fail to comprehend the RNSs, it's amazing.

"Not enjoying your incorrect posts again I thought the population of Europe was greater than that more like 750 million .Surely when the RNS was released on 01 Nov the test was not illegal to sell"

1)You thought wrong. Are you sure you should even be investing ?
"The EU covers over 4 million km² and has 446 million inhabitants"
https://europa.eu/european-union/about-eu/figures/living_en
I was 6M out, you were 304M out :)

2) Don't you even bother to read ODXs RNSs ? "
"......Health Security Agency's Medical Devices (Coronavirus Test Device Approvals) (Amendment) Regulations 2021 ("CTDA") which were implemented on 1 November 2021. "

Surescreen, having passed PD approval in March, is on the temporary list and therefore can continue to supply.

Calderkate, I thought the RNS was good news, and it still is, after a long long time, we actually get a deal for real product, and even an initial order with a firm cash figure (Ok, in excess of £750K, but when its frame like that, we know its not significantly more). It is good news for ODX and the uk market, and I said that on the day of the RNS. Although in absolute terms it is a small percentage of ODX capacity.

I did express concern by the exclusive europe side of things. DAM has a presence in some tourist spots, but really to give a company exclusive use to the professional test for the entire EU market of 440M people, that only have a few outlets seems like either ODX feels it's opportunities in the EU from the professional test is limited, or they needed to get a deal over the line and this was the price they paid. I hope they don't do the same for the professional test when/if they get EUA in the US.

But what has happened since is just bad form. ODX obviously well know the 1st Nov date. They chose not to mention when mentioning the first ever contract, a contract that at least at the outset is heavily schewed to the UK market, that on the date they announced it, the test became illegal in the UK. There was an excellent opportunity to smoother the bad news with good news. Their approach to PR is awful, and they amazingly managed to completely take the shine of what was the most important sales announcement all year.

"Surely the agreement is in force now"

It was cited as a "Head of Terms" with an initial order of £750K

"Where does it say a maxim of 200,00 tests will be needed a month?"

You're right it doesn't mention that ODX will be supplying 200K a month,

it says "DAM Health is currently using approximately 200,000 in-clinic COVID tests per month. "

We don't know if they are all antigen tests, probably includes PCR and antibody tests.

Frankly we don't even know when the agreement comes into force. so it might not be active until Dec 1st or Jan 1st.

Given that the ODX RNS seems to be a mostly a selective cut'n'paste from some others, I have been reading the other RNSs on the matter.

AVACT "This is a new requirement for the SUPPLY of any COVID-19 test in the UK and is over and above the CE mark and successful registration of Company's AffiDX test with the MHRA which was announced on 7 June 2021. "

DAM won't be stocking up on a test for which they don't have a timeline for approval, whilst they still have the ability to sell other tests. Why the hell would they ? ODX can apparently knock out 2M tests a week, DAM only need a maximum of 200K a month, that's less that 1 days ODX capacity per month.

I'd suggest that as the visitect test, like many others, became illegal to sell on the 1st of Nov, there was no reason why this could not have been RNS'ed on Monday. It appears that ODX, in contrast to the others, did not think it was necessary to RNS. So that probably says something about judgement right there.

But had they made the correct conclusion earlier, it would have been easy to timeline the DAM RNS to be after the CTDA RNS. Simply defer the final signing of the contract until the 2nd. It's not a contract until it is signed off. Then its good news after bad, not vice versa.

Having gotten the first real order for covid LFT in all of 2021, and I was hoping that another would come along at which time the company is showing momentum, it is just typical that they sign off on a contract the day before it becomes illegal to ship that LFT in the uk.

The wording of todays RNS is revealing:-

"This new legislation is not expected to cause a delay in the supply of Omega's VISITECT(R) professional-use COVID-19 Antigen test to DAM Health clinics in the UK under the agreement announced on 1 November 2021."

Surmise for a second that the contract says that DAM don't have to soley use Visitect in the UK until the test is legal in the UK, and that DAM won't be ordering for UK until that is the case. If you take that sentence, you can see how that is entirely consistent with the RNS today saying the "legislation not delaying supply to DAM clinics, under the agreement. If the agreement says no additional orders until CTDA approval, and CTDA approval takes 3 months, there is no delay under the terms of the agreement.

Words, as always, are chosen carefully.

So to summarise
ODX awaits uk government to decide if it wants to pick a test for ODX to make.
ODX awaits approval for professional use of Visitect in the USA
ODX awaits approval for professional use in the UK.
ODX awaits EU home use
ODX awaits approval for home use for the RTC antibody test
Does ODX now also await CTDA approval for visitect home use in the UK, can this only be applied for AFTER EU approval ?

The only place ODX can sell any antigen test is in the few clinics that DAM has in Europe, and for professional use only. The DAM agreement means they can not sell visitect professional to anyone else in Europe.

LOL, 29 likes and he told you black was white.

"Wessley what a a r s e h o l e you have become.
Twatchers b u m c h u m"

Nice bit of homophobic commentary there, as you obviously well know as you spaced it so that the lse detection software wouldn't pick it up.

Classy.

"No in effect no change to the tune of the flute"

More correctly, the flute wasn't playing a tune at all, so it still is not.

The elephant of course being that ODX announced the "first tune" in the uk only yesterday, whilst not mentioning that the test currently does not have the required approval for sale in the uk.

"the Secretary of State published a protocol listing certain TESTS that have both passed a PUBLIC SECTOR VALIDATION, and have a pending application awaiting validation, to remain on the market up to 28 February 2022 or until their validation application is determined."
(my capitalisation)

There is a temporary list of TESTS (not retailers)....nothing to do with the travel list which is retailers.

Given the list comprises tests that have passed "public sector validation", This has to be the PD list, as those are the only ones that the public sector can select for purchase.

business as usual from Reg.

I see abingdon is again using twitter to try to drum up distributors for the ABC antibody test.

Wonder whatever happened to those 3 countries that CK said in mid july were on the cusp of final validation which was to then lead to significant orders.

A bit more background on the CTDA saga from the trade body that represents the IVD industry in the UK.

https://bivdanewsletter.com/highlights/covid-19-desktop-validation-bivda-abhi-joint-webinar/

DAM uses 200K a month, 90%+ of their clinics are in the uk. The test can't be sold in the uk.

There is a pandemic, there are dozens of tests for sale in the uk for self-use and professional use.

It appears ODX does not have the required approvals to sell to either market in the UK.

"Due to a proposed global shortage in supply of LFTs,and indeed test component parts,i think it would be perfectly good business acumen to pre-order more tests before one would risk running out of them"

Running out of them LOL....ODX can theoritically make 8M a month, their problem is they can't shift them. And if DAM is up to full steam, its 2.5% of ODXs capacity. 1 weeks output would keep DAM going for 10 months.

"This is a new requirement for the supply of any COVID-19 test in the UK and is OVER AND ABOVE the CE mark"

The Novacyt statement today is categorical that THEY (the manufacturer) will only be supplying the single test that they have already secured desktop validation for, and will NOT be supplying the other 9 products until they have gotten the validation.

This is in keeping with the the AVACTA statement today.

Unless ODX has some magical exemption that applies to them alone, it seems clear to me that they will not be delivering any visitect tests to DAM for use in the UK until they get their desktop approval, as it is illegal to do so.

Strange how both AVACTA and Novacyt deemed it worthy to advise their respective shareholders, but ODX did not deem it necessary.