Member Info for RegulatorUK

"How do you know the enabling clause hasn't been used in the context of dialogue between the Company and DHSC Regulator."

Simple - because, as it applies to a DPS, the triggering of the enabling clause would apply to *all" suppliers under the DPS and would have to be formally announced as an amendment to the DPS. You can't amend the rules for a single provider and not others - that would be unlawful.

Yep.. and?

It says "During the duration of the DPS, DHSC may identify another regime(s), whether or not undertaken at PHE Porton Down, that may or shall be used to achieve the same objective in which event “Phase 3A Validation” shall, for the purposes of this Specification, the DPS Information Document, and any Application, mean validation by such regime."

That's an enabling clause... which hasn't been used to date.

Which means that currently - contrary to what has been suggested by the Avactolytes - "...to be potentially suitable candidates for use as a nationally deployed LFD as part of the Government’s Test & Trace strategy" tests must undergo testing by PHE Porton Down.

Again, as claimed by some Avactolytse, CE marking in and of itself does not replace testing by PHE Porton Down - it is a prerequisite to admission to that process.

"Me thinks that tweet should have been a RNS as it will affect the sp. Could be knuckles being wrapped?"

No need for it to be an RNS as it is simply restating known facts/information..

"If you study the latest Government requirements it is in fact not strictly necessary that the final Clinical Validation be carried out through Porton Down Regulator"

Really? Where does it say that?

(And, yes, I've read the documents from start to finish multiple times).

Do we actually have any real evidence (rather than repeated assertions on social media) that the Avacta test is currently being assessed by PHE Porton Down?

I believe it unlikely that they would be assessing a test that has yet to finish clinical trials and be CE marked by notified body/partner manufacturer.

"goldtrig you are on the wrong board. The board you hold shares in will be happy to see you over there."

They think he's a d1ck over there as well..

It'll bounce a bit as the day traders sell into the early rise...

"I didn’t know “around the end of q1” was last week regulator! As I said, I’m a holder of both, and much before you even knew what odx is"

I too am a holder of both. What I like about the ODX approach is that they under promise and over deliver...

We had one of the Avactolytes on here last week who repeatedly stated that, despite the clinical trials not being complete, the Avacta test was going to be CE marked last week.

We also have people telling us that CE marking means that further validation of the Avacta test by PHE for non-professional use is not required. It's simply nonsense.

"Regulator. They can't CE mark their own test. They are a 700m market cap IVD company without the required quality management system in place..."

Yep. They've got to get a Notified Body or third party manufacturer to do it for them...

"Regulator - people elsewhere questioning if TT is complete. Surely you can't CE mark a product which hasn't had the TT completed as you don't have a manufacturing process in place?"

CE marking means that the TT process is complete and the test batches have been run for validation. Ignore the ignorant comments elsewhere. Today is a good day!

Floreat Omega!

"Can I order the DB7 or is it still s bit off yet?"

*Channels Mrs Doyle*

Gwan, gwan, gwan, gwan, gwan, gwan, gwan.....

"... But also great to see confirmation that the UKs test of choice is very very likely to be avactas. Now we can all get along."

Not sure where you got that from in the RNS... has Avacta managed to CE mark its test yet? We were promised that would happen last week and it didn't.

Price looks good pre-opening...

That should put the cat amongst the market pigeons.

By the sea of green boxes, I assume that the usual suspects are doing their thing, criticising it and telling everyone its an awful RNS.

"Very happy to be holding based upon my own analysis. As an investor i appreciate the honesty in recent communications. i can understand why traders dont but hey theres plenty of rainbows out there."

Ditto!

"CE Mark is just approval for use as a reserach product. Need more than that to be used on public"

No - under the current legislation and rules, CE marking indicates that it meets the requirements of the Medical Devices Directive/Medical Devices Regulations and may be marketed for professional use.

With the exception of a small number of medical devices, CE marking does not allow supply for non-professional use. That requires further approval from the Competent Authority (which is not the same thing as a Notified Boby) - in the case of the UK that is the MHRA.

In the case of Covid-related LFTs, once CE marked for professional use, further assessment is required if they are to be used by non-professionals, e.g. by the public as part of the sovereign test project, or in conjunction with Test & Trace / PHE / ONS.

*whethey = whether they

The fact that some people don't understand that certain administrative RNS have to be published makes me wonder whethey should be investing in shares... or whether they'd be better off sticking to Lottery scratchcards.

"@extrader

If you want to buy shares in SYME, do you have to get permission from your leader and clear it with Wrexham HQ?"

His mummy has to give him his pocket money...

"Of negativity and Dunning-Kruger it is then."

*Snork*

I can't imagine who you might be referring to...

;-)