Member Info for RegulatorUK

"Ive added a few AVCT today as i have a lot of respect for mologic and if they believe the technical file for the product is worthy os submitting for CE marking that gives me confidence. My main holding by a long way is ODX though."

I'm not going to add any more to my Avacta holding - but it is nice to see some concrete developments. ODX will remain my largest LFT-related holding.

Any spare money at the moment is going into Spire Healthcare (SPI) shares. The Covid impact on NHS electives means private demand is growing significantly.

"I thought it had already was at Porton Down based on the newspaper report and RNS on the back of the report (22nd Feb) - that at least alluded to the fact that the test was at Porton Down."

There have been lots of claims about what is happening with the Avacta test (CE marking has been guaranteed 'this week' by some Avactolytes almost every week since January) not all of which stack up. PHE Porton Down won't have been validating a test that hadn't been through the basic clinic trials and been validated (which only finished a few weeks ago don't forget).

"Has the surescreen test been validated?"

Yes - it was the first test to be validated. You may also be surprised to know that the updated Innova test has also been validated.

"Could we be manufacturing the surescreen test?"

Yep - we could... or the Innova test... or (in time when it finishes the PHE Porton Down process) the Mologic test.

"The AVCT LFT has been submitted for CE marking via its partner Moligic Ltd. "

No - it hasn't. CE marking is something done by the manufacturer. It has been CE marked by Mologic (which is what the Declaration of Conformity is all about) and submitted to MHRA for marketing approval for general sale.

If Avacta want the test to be supplied to the government, it will need to be submitted for assessment/validation at PHE Porton Down.

The government can't order the Avacta test until it has been validated by PHE Porton Down. Now that Avacta has a CE marked test, it can be submitted for validation.

I don't believe there will be a single sovereign test but a group of tests. I wouldn't be surprised to see Mologic/GAD manufacturing the Avacta test and ODX manufacturing others.

"Sly - fair enough. But we had a heads up months ago that ODX were working on the AVCT test."

Did we? We had a heads up that Mologic/GAD was working on the Avacta test - but nothing to suggest that ODX was involved in any detailed work around the Avacta test.

"I would suggest TT would take about 5 minutes"

You might suggest that... but you'd be wrong.

"I’m no fan of Sturgeon but it is ridiculous to suggest that rhetoric will stop Govt from ordering from a Scottish based company."

Which f*ckwit came up with this claim? I've got them greenboxed already...

"Are also making test for Avacta..so Omega should also be going up not down"

Are we? At the moment we're manufacturing ABC19 and Visitest products.

Even if the Avacta test is chosen as one of the sovereign tests (which means it passing Porton Down screening) we'd still have the matter of TT to contend with.

I think Mologic/GAD will produce the Avacta test for the general market (until such time as it may pass the Porton Down assessment) and ODX will produce other tests for now.

"nope not yet, it was sent for CE approval."

No. It is CE marked (that's done by the manufacturer - in this case Mologic) and it has been sent to MHRA for marketing authorisation.

Interesting that the Avacta RNS doesn't give the S&S details....

"vaccine is less than 1% effective"

Oh deary me... another scientifically illiterate poster to green bin.

"How do you get a resolution on the AGM, seeking a change of CEO and board of directors?
How many votes are needed?"

Only a moron would want to get rid of a competent, successful CEO and board of directors.

"You hate the Govt and you hate Tories, we get hot Regulator.

But stating a blatant lie isn't going to help your cause:
https://www.bbc.co.uk/news/55278314"

Oh bless - another troll to green box.

And it wasn't a lie. If you rad the article you link to, MPs got their 2020 pay rise - it's the 2021/22 pay rise that's being foregone.

"the PM of New Zealand gets double what we pay!"

Not quite. The NZ PM normally gets about £240k a year - so about 50% more than the UK PM. However, they don't get the same level of additional benefits that the UK PM does.

And in NZ the salaries of both the PM and MPs have been reduced during the Covid period - here in the UK the Tories pushed through a pay rise for MPs.

"ps_1988 you havent fallen into the logic trap than anyone who doesnt like the current far right admin is a looney leftie have you?

You dont think politics is a dichotomy do you?"

I think you may have to explain some of the big words to him...

"Looks like a very positive RNS so fingers crossed for a rerate here."

It's positive but not definitive. I think we'll see some PI money coming in but I don't think we see II money coming in until the results of the Phase III trials are announced in due course.

That said, today should be a good day overall.

"Rise yesterday in expectation of news today - so what are we waiting for now ?"

I'm not expecting major news flow until next week. HMG is too busy with the elections (the counts for which won't be complete until Sunday).

"Don’t we distribute through screen4"

No. We undertake testing on behalf of Screen4 at the labs in Littleport.

"@JimBethell We’re investing in 2m LFDs per week by end May from British firms @OmegaDiagnostic and @mologic to stop the spread of COVID-19. Investment in talent will help "build back better" & create 100s of jobs".!

I think the reference to Mologic may refer to GAD, whose production capacity DHSC has procured, rather than necessarily the LFT itself (although it may be both, as I don't believe there'll be a single sovereign test but a range).

It's just a Price Monitoring Extension... nothing to get excited about. You may wish to google it to see what it's about.

"Love to see more more options eg TT of AVACT et al when they are available."

You might be waiting a while. We were promised CE marking of the Avacta test by the end of March... it didn't happen. Then it was the end of April... didn't happen.