Member Info for RegulatorUK

"Products can still be sold without a CE Mark, i was told."

Medical devices cannot be sold in the UK without a CE/UKCA mark unless they've granted a time limited EUA or an IUA by MHRA.

I'm not expecting any material news until Friday or into next week.

A wide range of Covid-related stocks are down this morning. Is it perchance the Ferguson Effect?

Coronavirus third wave fears 'diminishing' amid UK's rapid vaccine rollout (https://www.cityam.com/coronavirus-third-wave-fears-diminishing-amid-uks-rapid-vaccine-rollout/ )

Comments by Neil Ferguson on the Today programme this morning are being widely reported (and, to a certain extent, a little bit spun).

"Markets never cease to amaze do they? We will be lucky to finish blue ffs!!??"

Hardly surprising... it's the 10%ers taking their profit. It'll rise again later.

Be prepared for lots of new faces to show up on this BB to express doubts around the test...

"This is plant RNS nothing news in . the main is shares option get out that so boring now and just kill share off. people is waiting year on promise and they couldn't do anything better."

You what????

"I just dont understand why they cannot officially confirm the 374m order which would appease many many nervous investors."

There isn't a £374m order. There is a framework Contract with a maximum value of £374m - which has been formally confirmed/RNSed twice:

https://www.lse.co.uk/rns/ODX/uk-public-sector-contract-disclosure-ih0eb8gyvolnl9k.html
https://www.lse.co.uk/rns/ODX/statement-re-government-press-release-836fo2lcrenkdut.html

I'm not sure what more you're expecting...

"twatter is probably paid $1 per hour to de-ramp here."

I'm assuming his employer confuses quantity with quality...

"Thanks for your opinion Mr Adventurous. Maybe your company will have a ISO13485 approved QMS one day."

*Snork*

You owe me a new keyboard, tecbadger... this one's covered in coffee and snot.

"I just glanced at their board Regulator. Guinness world record attempt at confirmation bias ensuing."

Many on there with no clue around what the S&S figures actually mean - or how to read them.

"Whilst waiting to receive this confirmation, Omega is currently supporting the Government with additional cassetting and pouching services for other COVID-19 antigen lateral flow tests that are being deployed in the UK."

How long until the first Avactolyte claims ODX are making these for them?

3...2...1...

"I was with the UN in Zambia for a bit and their procurement procedure was whoever had the largest brown envelope or closest relation in the process."

Part of the reason why their processes have changed, with an emphasis on pre-approval of suppliers... although there are inevitably still aspects of local procurement.

Bloody autocorrect... that should have Ramadan:

“ Their procurement practices weren’t as sophisticated in my day.”

It’s over $500k *or* Time Bound LTA.

As I understand it*, the contracts with $ values tend to be ‘one off’ orders’ with a fixed value. Time bound LTAs are a bit like framework agreements. No guaranteed value but the potential for multiple orders.

*It’s been some years since I worked with the UN. Their procure practices were as sophisticated in my day.

"£1 million order for Odx and no RNS ?"

Where did you get £1million from? There's no value on the file for the ODX Order. We simply know it's a Long Term Arrangement.

It's not all about Covid...

"Cannot wait for Fourfiguresbull to sell and move on from this board."

I don't think he'll ever sell up and move on...

...as I don't believe he's actually invested to start with.

"Anyone know if Omega still has a manufacturing site in Pune, India?"

No. They closed it some time ago.

Looks as though it will be the NHS app - and not the NHS Covid19 app. I'm assuming that's because vaccination is being recorded in GP records, so it should (and I use that word advisedly) relatively easy to amend the NHS app interface to display vaccination status.

The question will be how Covid test/Track & Trace information may be accessed, as this isn't currently stored automatically on GP systems. What would concern me, from a privacy perspective, is how they might try and link the two - particularly as there are some dodgy firms involved in the Track & Trace system.

"Is it really necessary to create a post with every think bubble that pops into your head?"

I think 'thought bubble' is being a little generous - it suggest the capacity for deliberate cognitive function...