Member Info for RegulatorUK

"Refers to newly developed tests and additional supply shipped in for support to meet expected demand"

I think you'll find that a retrospective publication of a Contract Award Notice (hence Delivery details not completed). The wording around testing has been used in various forms in the Article 32 blurb for the last year.

We’ll see what Pharm2Farm have to say...

"There will be RNS to state MHRA approval, when received...."

Again, I think people are confusing CE/UKCA marking and MHRA approval.

CE/UKCA marking is applied by the manufacturer and/or an approved body when the medical device meets the requirement as outlined in the Medical Devices Directive/Medical Devices Regulation. It is basically certification that it meets the requirements, for the intended use, outlined in the MDD/MDR.

The manufacturer then lodges the CE/UKCA marking with the competent authority (in the UK that's the MHRA) and that gives the marketing authorisation.

That's different to MHRA approval, which relates to when either the device is not CE marked or will be used outside the intended uses outlined in the MDD/MDR. If it's not CE marked then MHRA can give approval for single use (normally in relation to use with individual patients) or wider use (via Exceptional Use Authorisation).

If it is CE/UKCA marked but is going to used outside the scope of the intended uses listed in the MDD/MDR, then MHRA can either give EUA or undertake it's own approvals process (as has happened in relation to LFTs that were CE marked for professional use being used by the public).

Type IIR masks need to be CE/UKCA marked - they don't need MHRA approval.

"Reg wind your neck In and stop talking total ballax

You have just opened yourself up to a libel case.!!!!!"

I can give chapter and verse on the medical devices regulations, CE/UKCA marking and MHRA approval. It's the day job.

I also know the libel laws and the statutory defences...

I've pointed out the claims to P2F - they can deal with them.

"Pharm2Farm 10-Pack Face Mask https://www.amazon.co.uk/dp/B08WJP9C51/ref=cm_sw_r_cp_api_fabc_TGQ3W9JDTC5WPFG10H74"

Now that's interesting. It's showing that there being sold by Amazon itself - but the RNS on 4 March said that FM London would have exclusive rights to sell on Amazon, subject to minimum orders.

So are Amazon selling when they shouldn't? Or has FM London pulled out of the deal RNSed last week?

I see now. The Magnesium Healthcare web-site is making that claim.

That is not correct. They have been CE marked - that is not the same thing as 'MHRA approved'. I note that they're also claiming that they are "used by U.K. Government Hospital Trusts". I don't believe that is the case and is potentially misleading.

It's worth noting that the official Pro-Larva site is very careful not to make such claims. I'll flag the Magnesium Healthcare web-site with P2F.

"clearly states : CE Certified and MHRA approved"

Where does it state that?

Just looked on Amazon. No sign of the Pro-Larva mask on there, either in its own right or via the FM London listings.

I see there are suggestions that it's on there - can anyone provide a link?

"Have I missed this or is this the NEWS!!! MHRA approved !!"

I think people get confused about the difference between CE/UKCA marking and MHRA approval. They're not the same thing and many people claim things are 'MHRA approved' when they're not - they're simply CE/UKCA marked.

"Who cares Regulator?"

The point I'm trying to make - and have done so repeatedly - is that we should *not* read anything in to the CAN not be published by DHSC in the timeline required. They're repeatedly failing to do it.

Some nervous holders may be put off by people saying 'Ooh they published Surescreen contract award notice in time' if (as has happened) they haven't yet published the ODX contract award notice.

Yes, this is going to take off and now if the time to hold, increase your holding or, if you're not in get in.

Oh poo... it's dropping back a bit. Hopefully as FOMO o'clock approached, it'll get the boost it needs to break the £1 barrier.

It looks like ABDX may (touch wood) have broken the £1 barrier today as well.

Floreat Omega!

"https://bidstats.uk/tenders/2021/W07/745144624

Surescreen contract
15/01 signed. Published 17/02"

It's irrelevant when it is signed. What counts is when the Contract was awarded - i.e. when Surescreen were told they were getting it.

And as this wasn't a the result of a competitive tender (hence the use of the Article 32 exemption) the Contract Award Notice should have been published within 20 days of the award notification.

"Are saying that the Surescreen contract was published a month after it was signed. Well 29 days afterwards to be precise. They are sharing bits and pieces. No idea how to check the veracity of it. As we have all noted they are sometimes on the money."

It depends on which Surescreen contract they're referring to - they've had a few...

The dates of award on some of the CANs haven't been given so you can't tell when a contract was awarded . On others it's clear they were published late.

In fact, I can't find a single Surescreen contract where the CAN was published in line with the requirements.

"Not sure your "fluff" argument is consistent Regulator"

I'm talking specifically in relation to the Covid test... and as an Avacta shareholder.

"Even if you believe the PR is poor at ODX you have to ask yourself do i think that contracts and numbers will eventually be in place which will shoot this companies value up? I do think that so tbh im not bothered if the SP is higher today or higher in a few months."

And we have to remember that most of what Avacta is RNSing are fluff pieces, with little real substance - which, as a shareholder, is a pain in the ar$e.

What I like about ODX is that their RNS are factual and related to actual, substantive developments. Like you, I'm not bothered if the share price is higher today, tomorrow or in 3 months time. I'm in for the long term dividends.

It would be rude not to, now that we're relisted and there's news incoming...

"How has this not been an RNS?!"

I know I criticise people for claiming that every Tweet needs an RNS... but this one really *should* have been an RNS.

“ The legend that is Shredz has clarified what we should expect and when for anyone who was a bit unsure like I was”

Except his timeline is wrong. As it was a direct award without a standstill period, the Government is supposed to publish in 20 days - not 30.

"I really think the ink would of been dry by now and figures would be out there, but we have left wingers(good law/deeks ) who won’t stop at anything to disrupt Proceedings."

The Good Law Project isn't there to "disrupt proceedings" but to ensure that those proceedings are being undertaken fairly and transparently - and that works in the favour of companies like ODX, Mologic/GAD, etc.

As John2015 says:

"Legitimate question - If a cumulative total of 100m tests of all kinds have been done ( source HMG site ) why has this cost £37bn. Even at £25 per test I make 100m x £25 £2.5bn - so where is the other £34.5bn going"

Nobody is saying that direct awards were not necessary in order to enable the government to act quickly... but their repeated failure to make those awards in an open and transparent way raises questions - particularly as publication of the Contract Award Notices is a simple task that takes little time and would be a 'business as usual' process for any competent procurement team.

Mix in the fact we know that in many cases:

- the contracts weren't awarded on the basis of what the company had a record of producing but which peer/minister/MP they knew,
- established UK suppliers were overlooked,
- prices were obscenely inflated, and
- what was delivered was often not fit for purpose

and you can see why there is need to hold the government's feet to the fire.

bankruptbrit and Bannister04 binned.