Member Info for RegulatorUK

"Good luck establishing a manufacture site in 3 months."

It'll take that long at least to get the ISO accreditation once the manufacturing facility is established...

My other half and I have a lot of accrued leave to use up (thanks to Covid). We've booked the week of his birthday off in mid-July. He wanted to fly off somewhere sunny (Madeira or the Canary Islands if they were 'greenlighted') but I've said the last thing I want to do is spending four hours breathing recirculated air (never mind the interminable waits at the airports).

I suggested somewhere in the UK/Ireland (I'd love to spend some time in Northumberland, one of my favourite parts of the UK) - if we're not in another lockdown - but he wasn't exactly enamoured of that idea. The he came across an offer for cruises departing from Southampton - which include up to 50% discount for frontline NHS staff and their families. We're tempted, if we can get the week we want.

It'll be interesting to see how the cruise company will handle Covid testing, etc. Luckily we're both fully vaccinated and have access to both LFT and lab testing. I've asked him to confirm what the pre-travel testing requirements are, as if they're not up to scratch I won't be happy...

"Well I am a longterm investor almost a year and whilst I have no time for those that constantly attack the company I also get rather annoyed with those who treat Colin as if he has made no mistakes and can walk on water! This last year has certainly seen many ups and downs with many of the more exuberant posters talking of £2 by Christmas! Colin himself initially was hoping for early MHRA home use antibody approval and then possibly early antigen Christmas presents.We have had a placing, Sky interview ,ridiculous amounts of Sneller and L and G shares dumped on the market ,finance director selling shares,factory closed for over 2 weeks at Christmas,negative slants on what should of been a fantastic RNS _ it has certainly not been all sweetness and light. To a large extent it is about seizing the opportunity { a diagnostic company in the middle of a pandemic} and trust in the management! Although waning Colin has mine at the moment ,not because I think he is a great CEO ,but rather a thoroughly decent bloke . I hope that the next month will be pivotal ,but if we get more MANANA and I end up selling one thing I will promise I will not return to spout negativity I will just quietly move on to my next perceived opportunity!"

How many of the issues you cite are actually down to the CEO? L&G, the FD and Sneller selling? Nothing to do with him.

Why was the factory being closed over Christmas an issue? The time was used to start the expansion of the premises.

"by "supervising" do you actually mean "ankle biting?"

As long as they don't go near his buried Dentistix they're fine.

No - a Jack Russell...

Morning T0n1c et al...

I've got the builders in today sorting out the damaged fence. The dog is supervising, whilst I wade through draft NHS contracts.

Nice!

“ The vaccines are not 100% effective and there is still a large part of the population still not vaccinated and ironically these are the ones we are seeing in the news in large groups. In my opinion there will be a reduced third wave and soon.”

We’re planning for a third wave in July.

"i do dabble. Also like to try and keep up on the progress of the precision medicine work there out of personal interest. Not mentioned much though."

I'm an Avacta shareholder as well, but I find that board (like a few others on LSE, e.g. RMS) greatly OTT and in great part adrift from reality.

I see you've stuck your toe into the Avacta board, tecbadger... I don't whether you're brave or foolish!

You do certainly seem to have something of a record for predicting sell-offs that don't actually materialise...

"Regulator
Your last reply
1. Deliberately misinterprets my last post
2. ignores our previous discussion on PHE validation.
Nice diversionary tactics"

Trot on Sleepy...

"Re the CE Mark.
We may have it. AVCT already have better results than Mologic used to CE mark their own test. The previous RNS on the subject covers it without the need for another. Its a non issue. When we come to sell we will have it!"

So you think that a CE/UKCA mark is a "non-issue".... riiiiiiiiiiiiiiiight.

"Re PHE validation (assuming AVCT decide to go with the government) this imo will be already in hand. You will recall we discussed this previously."

If Avacta wants its test to be considered as a sovereign test, then it will have to go through the PHE validation process. There is no other route.

And, if the current consultation proposals go forward, it'll need to be subject to independent validation to be sold in the UK, even if not put forward as a potential sovereign test. Avacta might have a test ready by the time the new regulations are in place...

"You ARE wrong RegulatorUK and you have repeated your "understanding" despite having been corrected by me!"

So... do we (Avacta) have a CE marked test yet? Or one that's made it through the PHE evaluation process.

Errr... no.

"If thats the case Regulator then my knowledge is outdated."

I may be wrong - but that's what I understood.

"The lack of a QMS backing the design was a big red flag to me when that product went to trial. Ive seen too many R&D companies with too much focus on the R if you know what i mean."

Oh yes...

I though PHE reran the test with fresh collections and they still failed?

The Government is holding a consultation on requiring all Covid tests offered for sale in the UK to be subject to independent validation: https://www.gov.uk/government/consultations/private-coronavirus-covid-19-testing-validation/private-covid-19-testing-validation

The idea is to weed out the less accurate tests being offered for sale in the UK, i.e. ones that have been CE marked but are not reliable enough. Personally, I think it's a good idea - anyone wanting to sell tests should demonstrate they meet minimum criteria via independent assessment.

ODX would be OK, as would the likes of Mologic and Abingdon. Some of the others might struggle a little...

“ Colin needs to show numbers soon, or im out. ”

Don’t let the door hit ya where the good Lord split ya...

It'll be repackaged under the EUA for surveillance testing.

A new one. Contract was concluded in March 2021.