Member Info for RegulatorUK

"PK1 - If you could just let me know the winning euromkllions numbers for this evening, that would be much appreciated."

Soz - you're too late. He's already given them to me.

"So the worst case scenario is MHRA CAN take up to 90 days -- so we are 85 days now and in the middle of a pandemic ! Great 5 days away from the maximum time in the middle of a pandemic and still waiting!!!"

What TyreTam has quoted is the process for medicines - not medical devices. Medical devices are subject to a different regulatory regime, for which there is no set timetable (other than 48hrs for an individual humanitarian use application).

then I'm going to have to start an opera thread.

"Omega is the 24th and final letter in the Greek alphabet. The word literally means "great O" (o mega, mega meaning "great"). So Great O... let's get this party started!"

Nice to see a classical education put to good use! :thumbsup:

"Sold some of my favorite shares odx reinvest here. Got in at .85"

Sold some of my BHR but didn't manage to get into until 0.9... :-(

Can someone please slap Punit? His needle seems to be stuck...

;-)

“He?”

Last time I looked...

OK - there is a bit of moobage that may confuse folks. ;-)

Don’t forget to ‘Wear it Pink’ for Breast Cancer Awareness today!

"RegulatorUK you patronizing prick, go and read my message properly"

I did - I even quoted it.

"Bit splitting hairs the logo and trademark part of the packaging"

You call it 'splitting hairs' - others call it understanding the basics...

"UNVR - MHRA is public sector... no way they would be working after 4.30pm the night before or before 7am to give the approval for an RNS. Very much 9-4.30am assuming it is within their core hours and not flexi-time, or lunch break, or union meetings, or 35 days holiday!"

Can we please knock the public sector bashing on the head? I have worked in both the public sector and the private sector (and still have a foot in both). My life in the private sector was/is far cushier than my life was/is in the public sector: fewer hours, more pay and more holidays (and even a better pension than my NHS pension).

I know the Daily Heil and The Torygraph columnists like to public sector bash... but they're the first to rely on those same workers when something goes wrong.

"Approval will come when they have enough stock to over supply the govt boris knows he’s had a great deal at the prices proposed to them .they would not have gone to the bother of the fabulous packaging which they are patenting for US sales if they didn’t intend this to be a retail shelf product when it is remember at least 1 in 4 will be boosting your sp dyor gla"

They are not patenting the packaging. Patents apply to IP - copyright applies to logos/trademarks.

"I don't get why it's taking so long to approve a gold standard test that can enable mass testing of the entire population, it's almost two months now. Still the government relies on slow PCR antigen tests, if they wanted antigen why did they set up a antibody test consortium in the first place?? Its just one bizzare decision after another"

Oh Lord...

Just for those who really seem confused, a reminder: PCR (molecular), antigen and antibody tests are three different things, have different functions and all three are necessary for any successful strategy to tackle a pandemic.

PCR and antigen testing (which, I would remind you are two different things) look for active infections - antibody testing looks for antibodies arising from prior infection.

If you don't understand the basics folks, ask yourself if this is really the sort of stock you should be investing in.

I am one of the first to criticise the complete mishandling of this pandemic by the incompetents in the Cabinet - but you really can't knock them for establishing and supporting the UK-RTC. It was one competent decision in their monumental flustercuck...

"Regulator some thing has definitely happened to the product as they ciga are unable to sell this privately and now they expect private sales end November."

And how is that linked to MHRA approval?

CIGA is managing the sale of professional POC tests. These are CE marked and not subject to further MHRA approval - that is only required for self-test use.

I would suggest the reason professional POC sales are not being processed by CIGA is fairly obvious - DHSC has not yet agreed that third party sales can be made as it wants all the production capacity in the short term.

No conspiracy...

"It appears that MHRA approval could be being blocked by the government for the reasons discussed previously, "

And those reasons are? Something substantive rather than conspiracy theory please...

"I highly expect it to be innova that’s being rolled out??

http://bidstats.uk/tenders/2020/W43/737214508

“ INNOVA are providing Lateral flow test kits to support the UK Covid-19 testing strategy and to enable mass testing for C-19 through rapid testing and to supplement diagnostics capacity.”

Highly likely we’d get MHRA update before national roll-out!"

The Innova test is an antigen test. It's also a company that is part of the £1.3bn procurement challenge launched by the Good Law Project in the High Court. This could get messy...

"That was short lived. Oh well, see you at the next one!"

You need live prices...

This explains why AZ has been noticeably quiet over the last few weeks...

Almost 3 bagged on this but I think I'm going to see this as a LTH.

It was on here yesterday...

"i find it strange / artfully vague why the rns doesnt say something along the lines of ' following delivery the sum due to vast is xxx amount payable within 30 days ' or whatever"

Why on earth do you think they'd put that on an RNS?

"The only thing he needs to do is buy more bloody machines..simple.At least he will have the plan on how he’s going to achieve this by month end...that’s if he’s allowed to tell us..lol
Buy more machines...hopefully this was done months ago."

If you watched the last presentation, he told us they were doing just that...