Member Info for RegulatorUK

"Regulator - what does it matter what stage their test is at you muppet??"

If you have to ask that question then you clearly don't have a clue.

Aren't you supposed to have your phone in your bag when you're in class?

"BRH have partnered with Sheffield University, this would make a lot of difference to the validity of the application."

Not really. All of the various UK test developers are partnered with universities. It's a bog standard step - it doesn't mark anything out as special.

"Government should take a look at this 5 minutes test and ditch 20 minutes test.
I am hoping matt Han**** will at some point notice BRH and university of Sheffield efforts to help me 5 minute tests to come quickly before the winter starts."

Given the government sh*t-show to date when it comes to purchasing tests and the criticism that engendered, they're unlikely to want to fund anything that isn't even at the design freeze, never mind validation, stage.

BRH is a long term hold for the wise investor - not a get rich quick stock for the day trader...

"Good Progress here, should get UK government funding at some point".

It's not UK-RTC and it's not in the CONDOR Scheme at present, so unlikely to get government development funding. That said, I'm quietly confident of the potential and am keeping tight hold of my shares, which have already 3 bagged (and more).

Seemed rude not to top up at 58.2...

"... I’m starting to think /worry that the AVCT test is further ahead than we are being led to believe."

Not according to their last RNS, which let slip it was further behind than many people suspected.

"Ton1c that's just an article.... 99% of orders across the sector have been antigen"

Err... no they haven't. Certainly not in the UK.

"There won’t be any bounce until any orders are confirmed!!! Same old crap story here!"

Are you and DumbleD a double act?

"and who says they are not running some wp in parallel?"

They are.

"I see the ramping brigade are out in force again. The Odx bod need to announce orders. Not more tests for the shelf."

And, as if by magic, DumbleD the Disinvested Deramper appears with his usual tired and childish spiel.

"There are 9 work packages, we are just entering WP4. It’s likely early next year."

No - we're entering Work Package 5.... hence the heading: "WP5 Development of Optical Detection system".

"UKGOV are probably dragging their heels signing as 'they hold all the cards' and it will be ' the easiest deal in history '"

It's being delayed as the UK-RTC is having to deal with the most incompetent and corrupt ministerial team ever to 'grace' the DHSC...

whilst the executive agency that would advise said ministers is be demolished and the deckchairs rearranged in an attempt to cover the arses of those minister for their disastrous policy decisions...

and DHSC has been hollowed out, with most of it's most experienced and competent staff gone.

...and dropped a nice RNS. :thumbsup:

"Newvestors posts read better when they are in green print"

As do Affirmer's... are they perchance related?

"3rd September there is a webinar for India.(India only ).. wonder if we will have an rns with regards to orders for India...soon ???"

That's my birthday....

...an India order related RNS would make a nice pressie! :)

There's some worrying clinical illiteracy on display here...

"P1
Investors are entitled to call the company into question when they set dates and don't meet them.
As for a 10k investment try nearly 10 times that"

What dates have Omega set and not met then? What has impressed me is that where Omega has set a date (i.e. it in control of the timetable) it has met that date. Every time...

We are now in the position that the Consortium is dealing with a part of the timetable it has not set and does not have control over. It's dealing with an incompetent and corrupt administration, that's rearranging the deckchairs in the middle of a pandemic, which is supported by a hollowed out and inexperienced team at DHSC.

News will come... and I am sure that those parts of the future timetable Omega have set and have control on they will meet.

"Why would they tech transfer "immediately" if BBI hadn't produced a batch yet and these test will require no further validation? The BBI process has started. ISO13485 accreditation likely already achieved. Everything ready to go apart from CONDOR approval. Hopefully they pull their finger out!"

From the RNS, ICYMI:

"Avacta aims to begin clinical validation of the test as soon as possible using the first pilot batches."

"The Affimer reagents that we have generated are very specific to SARS-CoV-2 antigen and we are confident of meeting and exceeding the clinical performance requirements for identifying the most infectious people."

"I look forward to updating the market on progress in that regard, and will keep the market informed on the key next steps of clinical validation and regulatory approval."

This is clear. There is not yet a clinically validated product, never mind regulatory approval. What they're doing is, sensibly, ensuring that they have sufficient compliant manufacturing capacity to call down, as and when a clinically validated and regulatory approved product is ready to manufacture.

The key sentences are this ones:

"Avacta aims to begin clinical validation of the test as soon as possible using the first pilot batches."

"The Affimer reagents that we have generated are very specific to SARS-CoV-2 antigen and we are confident of meeting and exceeding the clinical performance requirements for identifying the most infectious people."

"I look forward to updating the market on progress in that regard, and will keep the market informed on the key next steps of clinical validation and regulatory approval."

These demonstrate that, despite being part of the CONDOR programme, they don't yet have a clinically validated product - never mind regulatory approval for the product. Which is very different to the picture being painted by some posters on their BB.

We're going to get lots of trolls from the Avacta board today I reckon. They've had an RNS this morning and, for those who understand the development process, it's quite enlightening. It seems to suggest that Avacta are some way behind where many PIs may have thought they were.

Hey unsteadyeddyguy.... aren't you supposed to be back to school today?