Member Info for RegulatorUK

Right, I'm off out to take the dog for a walk. Can we have £1+ by the time I get back please?

Ta!

It’s going to be a fun week!

“ Imho :some posters are dreaming or just living in Cuckoo land;More people will die of winter flu than from Covid between now and end of December”

No, they won’t. You clearly have no clue about the epidemiology of winter ‘flu.

Seems we have another nerk to filter...

"Already approved for professional use. If they didn't accept it wouldn't have been approved. Just Usability being reviewed for home use."

The professional use POC test has been CE marked - that's not the same thing as MHRA approval. CE marking is done by the manufacturer, when they are satisfied it meets the criteria under the Medical Devices regulations. The device is then registered with the MHRA but is not subject to MHRA approval.

MHRA approval is required for the self-use version of the test. That is assessed against criteria set by MHRA (the 98% referenced).

"Why isn’t the presentation on the odx website I wonder?"

Because it hasn't happened yet?

"Wow great find"

It was on here last night...

"CK will be speaking at the presentation Monday 5/10/20 where all will be revealed. Lots of press coverage over the weekend, UK-RTC coming to an end, test now on sale and orders coming in, Ducks lining up nicely for a great Investor presentation."

The UK-RTC test is *not* on sale at the moment. Pre-orders are being taken for the professional POC test.

The test that is on sale is the Visitect Triple Antibody test, which is nothing to do with the UK-RTC.

"Some really sensible comments by a doctor on Sky News re herd immunity and how it allows the general public to get on with their normal lives, whilst protecting the vulnerable as much as possible. Now can anyone explain how we can tell very quickly and effectively how we can test for who has had it?"

Who has had it =/= herd immunity.

To gain herd immunity through a non-vaccine route would cost millions of lives... and that's before we look at adding in the costs of the long term effects of Covid on those who have had it (we're finding out more and more about the significant impacts of 'Long Covid' every day).

The value of the ODX tests is in:

- helping manage restrictions until a reliable vaccine is available (which will be late 2021 at the earliest)
- helping with the roll out of a vaccine.

Herd immunity will only happen once sufficient spread of the vaccine internationally has happened. Even the most optimistic assessments are saying 2024/4 at the earliest.

That's a long term market for a reliable test...

I think it will do the usual ODX shake... up a little, down a little, back up a bit. There may be a tinge of WWTBOOTOTW about 3.00 p.m. but it's not going to sky-rocket...

But then again, this isn't really a share for the 10%ers but for the long term holders who can see the value in the wider ODX portfolio.

"In the last RNS that's what he was trying to tell us discreetly, that we are ready and our product is ready

"Within the presentation the Company provides indicative guidance on timelines for product evaluations, product supply, potential timing for first commercial sales and targeted production volumes."

But he can only officially announce it on Monday, but as last time the other company have already leaked out the information, b y starting to sell it already

Happy days"

Let's put this canard to bed (to mix my metaphors)...

- The test that is currently on sale is the Visitect (Mologic) Triple Antibody (IgG, IgA, IgM) test - not the UK-RTC test.

- The Visitect Triple Antibody test is a CE marked professional use only POC test. All the proceeds from this (bar a small license fee) go to ODX.

- The UK-RTC test has been CE marked for professional POC use and is currently being offered for pre-ordering (via CIGA on behalf of the consortium). When sales are made (which are dependent indirectly on any government order) ODX, as a member of the consortium, will get a share of the proceeds - not the whole lot.

- We are awaiting MHRA approval for the UK-RTC test for self-use, which is tied in with the government confirming any order. When any government order is placed ODX, as a member of the consortium, will get a share of the proceeds - not the whole lot.

...means the trolls are out in force.

Friday best wishes to all the genuine holders! I have a feeling today is going to be a good day.

"It is marked for professional use / non public use which is why is can only bought in the packs. This is a way around the rules."

It's not "a way round the rules". It *is* the rules - that's how the CE marking of medical devices works.

"What happened to the general consensus that the reason there were no order announcements was because they could only take pre-orders until the government confirmed their required volume.

That fact seems to be out the window, so why were they no orders prevciously ?"

As trilla says, this isn't the UK-RTC test.

The UK-RTC test is a single antibody (IgG) test. The Vistect test is the Mologic triple antibody (IgM, IgA, IgG) test. This was CE marked for professional use.

The Visitect range is ODX's in-house test range that is in addition to the UK-RTC work.

"Have to hand it to you long term holders here you sure have some patience waiting for the golden RNS on what seems an ever extending timeline.

Hope the rise is as good as you are hoping you’ve certainly earned it."

That's just it.... there isn't going to be some "golden RNS" - that's not what ODX about.

This isn't a share for the 10%ers - this is a share for long term investors who understand the breadth of the ODX offering.

"What a stupid remark. Hardly a 'failed' business leader if you look back over his career at Sainsbury's and what he delivered from a digital and operational perspective."

If he was that good, he wouldn't have been pushed out of Sainsbury's and he'd still be operating in the private sector - rather than being given a sinecure in the NHS.

NHS Test & Trace needs competent leadership from public health experts - not more 'jobs for the boys'. Particularly when it's going to be responsible for deciding who gets what contracts for testing and test kits...

Every new leadership appointment outside the normal recruitment process increases the risk of future procurements and contracts being awarded on the basis of who you know rather than what you can produce and how good it is.

"Mike 'we're in the money' Coupe!"

Another failed 'business leader', in the mould of Dildo Harding, appointed via the 'donations' network...

"They’ve been selling the antibody test to be administered for sometime unless uk gov have decided they will take the priority and exclusively making for them ?"

We need to be clear - they've not been selling the UK-RTC professional POC test. CIGA have been taking pre-orders (expressions of interest), pending a government decision. Once a government decision is confirmed the consortium will then know what capacity will be available to service those pre-orders and they can then be transferred to firm orders.

We would only expect an RNS for significant orders that would potentially have a material impact.

"RegulatorUK

the arrangement with the RTC, would this account for the lack of an RNS from ODX?"

Of the consortium members, only ODX is listed nd required to submit RNS to the market. Given the potential of news of an RTC order to impact the share price significantly, the BoD will be careful about how and when any RNS Is released - and it may also be impacted by any DHSC news embargo.

"This may sound like a ramp buts it’s a possible fact, each member of the RTC consortium can retain the £13 from however many tests they sells, we know ODX is gearing up to manufacture 8M tests a month, we could be looking at over £100M a month of revenue for ODX with £80M a month profit - EBITA level"

Each member of the consortium won't be selling. The consortium will be selling as a single entity, via CIGA. the manufacturing partners, such as ODX, will receive a share of the profits - not the total profit.