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The Preliminary report from the Joint PHE Porton Down & University of Oxford SARS-CoV-2 test development and validation cell: Rapid evaluation of Lateral Flow Viral Antigen detection devices (LFDs) for mass community testing
https://www.ox.ac.uk/sites/files/oxford/media_wysiwyg/UK%20evaluation_PHE%20Porton%20Down%20%20University%20of%20Oxford_final.pdf
explains some background to their role as distinct from the usual approval route
"DHSC Ministers therefore commissioned PHE Porton Down to establish a time-limited SARS-CoV-2 LFD test
development and validation cell in collaboration with the University of Oxford. In this document, we report on the
systematic and rapid evaluation of LFDs over the past three months, which have been used by HM Government
to inform decisions on increasing rapid COVID-19 testing capability in the United Kingdom."
@peka
Thanks for that, very promising - let’s hope pressure ramps up now and we get rid of these things.
Come on BBC, pick it up and run with it....
The Times, Torygraph and Grauniad have published articles about the FDA's recent statement on the Innova lateral flow tests:
https://www.thetimes.co.uk/article/us-raises-alarm-over-innova-medical-group-covid-test-kits-used-in-britain-fqvqwpcwz
https://www.telegraph.co.uk/business/2021/06/11/blow-test-trace-scheme-asus-watchdog-queries-rapid-covid-tests/
https://www.theguardian.com/world/2021/jun/11/us-health-agency-gives-innova-lateral-flow-covid-tests-scathing-review
But if there was mis direction, or deceit, by said supplier, such as false info, or it was insinuated all was ok, then said persons approving it, could be exonerated, and decide to re think their approach! #thinbutplausible?
Great be see some getting involved and trying to do something to raise the profile of this scandal.
Make no mistake, if this story doesn’t break then there is a good chance nothing will change. So, please donate 15 minutes of your time today towards helping UK society AND positively support our SP. Just make one call, or write one e-mail cheers, that’s all.....
Let’s DO something positive.
@Porky9
'The process is not totally clear'
I actually think that's intentional so that the Govt can pull the wool over peoples eyes and deflect the blame when things go awry somewhere else. I can't recall all the new advisory groups, scientific or otherwise they've set up in the short time they've been in power nor the number of people who have resigned and been replaced etc.....
I would also question their independence as this Govt literally wants to control everything as they are paranoid about anyone diminishing their power which enables them to line their own pockets at our expense.
@Kaeren
Just noticed your earlier post.
Nobody has responded I believe because the process is NOT totally clear, it looks like the DHSC COULD go against scientific or validation advise from PHE Porton Down, but I would think that highly unlikely, but both DHSC and PD are part of the “Oversight Group”. If DHSC approved something not validated and it caused damages a legal claim could be substantial…
From my research IF you are a business with an LFT device, in the first instance you apply to the DHSC. They will then undertake a desk-top review, including the submitted details of manufacturers’ claimed performance and instructions for use, to identify tests which may perform with sufficient sensitivity and very high specificity to enable them to be used to detect and direct responses to emerging outbreaks.
IF they do not like your application, or do not think your product is of sufficient standard the application goes no further and you are rejected.
IF they consider your product is of sufficient standard it is then passed to PHE Porton Down and they continue the validation process steps we previously outlined which starts with the manufacturer sending 500 of their test kits to go through the validation process.
At this point the product goes through all the evaluation process stages 1 to 3a.
Meanwhile, The Medicines and Healthcare products Regulatory Agency (MHRA) provides ongoing regulatory oversight, it is not able to directly grant a licence as far as I know without the product clearing the DHSC “Oversight Group” process.
So, regarding Innova, as it previously passed the evaluation process it COULD be possible that DHSC grant an extended license without further checks BUT would they really do that? Especially with the information they now have to hand. Also, the PD evaluation process is much more advanced now than it was back in sept 20 as such the Innova test should be properly re-evaluated. Anyhow we will know one way or another by Tuesday.
If anyone has more knowledge / experience on the above happy to stand corrected - Thanks
Pork’s
Apologies if already posted but this video provides good account of Delta variant on our shores. https://twitter.com/bydonkeys/status/1404822229939113989?s=21
Thanks to Simon Conway. ODX shareholders must also be up in arms over Innova. Hope you guys manage to get this episode out in the open and those responsible are made to face the music. One for Good Law Project to consider?
I have also sent this to the GB news team , feel free to use or tweak to send to any other media outlet .
Dear sirs/ madams .
May I firstly congratulate you on your new show , it is what the U.K. needs an unbiased , less politically linked broadcaster .
I’m emailing you all to make you aware of the innova lateral flow tests that our government continue to use with DHSC approval .
The accuracy of these tests are very questionable regarding sensitivity and specificity ( false positives and false negatives ) yet our government have spent over £2 billion of tax payers money on them and plan to open a new site in the U.K. mass producing them .
It may be worth you running a story on this ?
Your story may save lives .
Below are some links you may find of interest .
https://www.bmj.com/content/373/bmj.n1514
https://www.mddionline.com/covid-19/dont-use-covid-19-rapid-test-fda-warns
https://www.fda.gov/medical-devices/safety-communications/stop-using-innova-sars-cov-2-antigen-rapid-qualitative-test-fda-safety-communication
https://www.statnews.com/2021/06/10/fda-accuses-company-of-distributing-unapproved-covid-test-using-falsified-data/
I hope you at least raise awareness of this and if possible / allowed run a story as this cannot go on .
Thank you in anticipation
Pharmacy direct ....test and trace ...innova ....ian hislop ...likes a good story ...too many fingers in the pie .. ..genesig. will always be wanted worldwide ....as will pathflow .....
@MS
The "American" company BS was really just a smoke screen, a fronting sales office, so that government could say they were dealing with an American company rather than China.
The entire product down to the packaging has been developed, manufactured and packed onto pallets for collection in China. We even had to sort out the air freight to ship the crap back to the UK, orders COD you just couldn't make it up..
If government grant the license they can continue to buy more of it direct from China
I have just emailed mrs Churchill .
@vanv
Many thanks
Thanks Van, will use that.
Doubt many will try, but a concerted effort might tip it over the edge. Got to be better than talking amongst ourselves.....
A lot is made of being positive and supporting what you’re invested in on this bb. Whilst I always try to look at things as positively as possible, positivity itself on a bb makes zero difference to SP or the Covid situation in general.
Spending 15 minutes to try and flag this up to the media might, just might work. Your call. You can sit at your keyboard and make positive noises tomorrow, or you can take simple, positive action instead. Which do you think stands the best chance of success, regardless of whether you are seeking financial gain, or simply have a desire to see government to do the right thing? Have fun.
How do you petition Parliament?
Create or sign a petition that asks for a change to the law or to government policy.
After 10,000 signatures, petitions get a response from the government.
After 100,000 signatures, petitions are considered for debate in Parliament.
Petition Parliament and the government - GOV.UK
https://www.gov.uk/petition-government
@MS
As far as I'm aware, its now the 'indestructible' relationship according to our so-called PM.
@Porky
Your part post:
"Further, we are not supporting trade with the USA if they are saying the tests that Innova produce are not fit for purpose and should be immediately "thrown in the trash"
**********
Would that than also mean that the test cannot be manufactured in the US (for export only) and would that then mean that, if the UK gov still wants innova, they have to buy it directly from wuhan, as manufacturing in UK is not available yet?
Would that go down well with the special relation partner....
MS
@VanV
It's also the duty of a true patriot to protect his country from its Government.
Troublesome, sadly all the questions are prescreened before they’re asked. The PM knows which questions are coming and they have tight guidelines for what they can ask, the press conferences are pointless these days. For all piers Morgan’s downfalls at least he held MPs to account and didn’t follow a narrative.
Van
We probably all have a similar view on easy, logical and ethical actions should be taken. At this time, I do not think our government share those views.
This simply has to get serious airtime, or it’ll wither and die, along with all the other scandals before it.
We know, very few people do. We cannot complain down the line if we knew, but did nothing.
Radio, TV, online, print media etc etc. Just one call or e-mail each. Simply put the FDA findings out there, loud and proud....
@VanV
Do you think the PM understands all that.
I couldn't even understand what he said, especially during the first half of the briefing.
Why weren't they asked any difficult questions about testing etc.....
They are literally 'getting away with murder' and it appears that nobody truly cares.
When the footballs over, I'm sure that will be confirmed.
@RBMInvest
Think you're correct re: public awareness of the matter or its seriousness.
Most of the media suppress news that might reflect badly on the Govt and don't give it the longevity it deserves.
They are generally more concerned about celebrities, holidays and weddings etc.. with the occasional tale about some funny animal with the so-called beautiful game given top priority and everything associated with it including all the terms which fit neatly into the nationalistic populist agenda.
Wrong thread, weirdly it posted in this one. Meant for the ctea ramp bait, not for regular posters here
Troublesome
All the more reason why we should all undertake to make one call, or write one e-mail. We’re all preaching to the converted in here. Why not do something of real importance, as a group, and just TRY to make a difference?