Member Info for RegulatorUK

I'm not sure if this requires an RNS. It's just the publication of a Contract that's already been the subject of an RNS (https://www.lse.co.uk/rns/ODX/uk-government-contract-for-uk-rtc-ni9se8p1la3tcgf.html).

Yebbut.... Dundee's so 'meh!'

;-)

"We are expecting confirmation of non gov sales in the supply agreement.
It needs to come with details of further capacity expansion IMO.
If units > 200k and price per unit is > £1.50 it should be a huge catalyst."

CK gave an indication of further expansion in the investor presentation. It'll be interesting to see whether the expansion is in Alva or Littleport - or whether they'll consider an additional site (there's a few in this area that would be suitable).

What contract?

I'm talking about the professional POC tests that CIGA's been taking pre-orders on... the consortium couldn't firm those up until they knew what the initial demand was from the government.

What we need now is some details of the agreed professional POC orders. Those will potentially dwarf the government's initial order - and will be at full market value.

"Regulator its a contract of 10m for 'components and materials for lateral flow test kits for covid 19 as part of.....antibody testing.'. "

It's not the 'raw materials' - it's the tests themselves. The terminology being used relates to the CPV classifications and the fact that the tests will be included in a further 'package' ( being sent out by PHE) and thus are classed as 'compenents' for CPV purposes.

"RegulatorUK. that was back then and if it was only an understanding and not a signed agreement then the price will be more than £3. I would be asking for as much as I could get or sell it to the highest bidder. Make money while the hay shines!"

The government funded the development of the test and they will have negotiated access to the test on a 'first call, discounted' basis. As a quid pro quo, the consortium will be able to sell any surplus on to the open market (e.g. as professional POC tests) at market rates.

"Wow! I assume that 10Mill order is for parts only so that Abingdon can acquire them and distribute to the consortium! If thats the order for parts alone then the order for the actual tests will be a hell of a lot more than that surely!! Any shed some light?"

No - it's the order for the tests (don't be confused by the wording used in the Contract Award Notice). It is granted to Abingdon as it is the consortium lead (and the consortium doesn't have a legal persona and therefore can't enter into a contract in its own right).

The value of the Contract is £10m. At the moment, as I understand, the initial order if for 1 million tests at a costs of £3m* - so there's at least another £7m worth to be ordered.

*If I remember correctly, the government are paying Abingdon £3 per test.

Interesting.... the value of the contract awarded is higher than the value of the number of tests ordered, which would indicate/confirm further orders are planned.

Once the new consortium agreement is in place, I'd expect some news about non-UK governmental orders. CIGA's been taking pre-orders on behalf of the consortium for the professional POC test and these should be being firmed up now.

“ Don't really understand the science; But NHS to roll out mass vaccine end of October; 2 vaccines to be taken 28 days apart; results will be known end of November”

The NHS is not rolling out a mass Covid vaccine this month. Stop posting nonsense.

“ Its always jam tomorrow with this stock
SP is purely at current levels from hype and nothing else. Fair value is around 40p which is where I see it when Astrazeneca release their vaccine end of October”

AstraZeneca won’t be releasing their vaccine at the end of October, as anyone with a modicum of knowledge on vaccine development would know. I’m afraid your less than subtle attempt at a deramp will get treated with the contempt it deserves.

“ It's obvious that Colin will need to massively pump up production over the coming months.
I don't know what capacity is at his disposal in Alva, so far as production space is concerned. I wouldn't be surprised if he's pondering an acquisition somewhere. Time will tell.”

Alva’s not their only plant. They also have Littleport in Cambridgeshire.

"I’d expect it to show here..
https://www.gov.uk/government/publications/medical-devices-given-exceptional-use-authorisations-during-the-covid-19-pandemic/list-of-medical-devices-given-exceptional-use-authorisations"

I wouldn't expect the UK-RTC AbC19 test to appear on the exceptional authorisations list, as it won't be granted an exceptional authorisation as such. Those are granted for emergency use - the UK-RTC test has been through the full process. It has been CE marked for professional use and will get MHRA sign off for self-use.

"It's just a test order but nets ODX a few £million."

It doesn't. The 1 million order is split across the whole consortium. ODX will be producing 175,000 of the first order (and at least 25% of any subsequent orders).

"Can someone enlighten me do Mhra sign of on the suitability of a product to be used by an individual as opposed to a medical professional If so would my little prick your finger diabetes blood sugar machine have this if so there appears absolutely no difference in the concept thank you"

They're completely different things. Glucose monitoring is based on established clinical information and technology. The output impacts an individual.

These self-use Covid tests are based on relatively novel technology and require precise measurements, and have been developed using rapidly changing clinical information. The outputs could potentially impact more than the individual, as we're talking about an infectious diseases.

"Yes you are correct, this is merely a task which requires review of documentation and then (if necessary) pose any questions to ODX. When I was dealing with the MHRA you normally get assigned a lead assesor. I'm sure ODX will have the main contact they are dealing with at MHRA, would be good if CK can chase..."

ODX and CK won't be doing this - it'll be done by Abingdon Health, as they are the lead manufacturer. We mustn't forget that when it comes to the UK-RTC AbC-19 Rapid Test, ODX is just additional manufacturing capacity.

This won't require an audit. It's a paper sign off for the self-use aspect of the test.

Deeks' recent tantrum may prompt MHRA to ask a few questions but those should be easily answered.

...on my Covid portfolio. But still up overall - and significantly up on ODX (with an average price of 41p). The markets generally are going to be shaky in the coming weeks and months, particularly as new restrictions come into force in the UK, with the US election less than a month away and Brexit looming at year end.

But one thing I'm not worried about is ODX. This is a long term hold for me.

Mortuary van for Havilland5....