REMINDER: Our user survey closes on Friday, please submit your responses here.
"Once you get MHRA, you can sell to anyone in the world. Fda will not even be needed"
That's simply not true. MHRA approval does not replace the requirements for approvals in other jurisdictions - even in the EU. However, it will make life a hell of a lot easier, particularly where there are levels of reciprocity of approvals agreed.
Funny - they all seem to have disappeared suddenly...
"Will be over a £1 by the end of the week after ODX is forced to also admit the order, makes me angry how these companies think they can hold back this type of information, its tantamount to market abuse."
I think BBI have jumped the gun, rather than ODX wilfully withholding. I guess there was an announcement due very shortly - any RNS will now have to be moved forward, as the cat is out of the bag.
2p more and I'll bag....
I have a copy as an image which I've tweeted...
https://twitter.com/UKRegulator/status/1302953033903599616?s=20
"Finally bloody finally!
Rising like the Falcon from the ashes!
Covid19 here we come!"
Like a phoenix even...
"Where’s DubleD?..."
Who cares?
"I have emailed ODX PR asking why no RNS, suggest others do the same.
omega@walbrookpr.com
Omega and their PR, need to be a bit more proactive.
Aberdeenman"
I've emailed them. I'll be interested to see if I get a response.
"It should be RNS'ed yes I totally agree, but that is at the discretion of the government. So governments fault not Omega's IMO."
That's nonsense. The responsibility for informing the market via RNS is the company's - it's nothing to do with the government.
If this tweet is correct there there should be an ODX RNS shortly, as this is market relevant information.
Anyway, we'er at risk of wandering off topic.... which is ODX. So I shall return to that topic.
"Oh and the benefits bill is far far lower than the cost of furlough at 80% of salary at up to £2500pm"
The majority of those furloughed were in the groups who salaries wouldn't get anywhere near the furlough top cap.
And the costs of unemployment are far higher than simply the JSA/UC (or whatever it's called at the moment) costs.
In the longer term, furlough was a better response than seeing large numbers of people being added to to the unemployment lists, where the benefits bill (and related costs) would be considerably higher.
Fall's across all my Covid related shares this morning - apart from ODX and SYME. The news is I'm still up significantly over all.
‘Confidential’ document warns second Covid peak could hit NHS five times harder
https://www.hsj.co.uk/coronavirus/confidential-document-warns-second-covid-peak-could-hit-nhs-five-times-harder/7028380.article
"It’s clear you haven’t a clue what “validation” entails. Bottom of the class."
Really? Given your posts to date on the subject, I'm willing to place money I probably have a better idea than you.
"On sale on Amazon at £9.99.
Million going to 2 million a week income, mostly profit. £4 a share."
No they're not:
"The Government has asked Amazon to partner with them - alongside other retailers, life science companies and academic institutions - to aid in the fast-track of testing for the Coronavirus (COVID-19). You can find the official press release here.
These tests will not be available over the counter or for purchase online from any retailers.
We are using our logistics network to support the NHS with their plans. Further details will be set out by the Government in due course and we will update this page with more information as soon as it becomes available.
We believe our role serving customers and the community during this time is a critical one, and we are committed to working closely with the Government to identify ways in which we can support efforts to respond to the crisis.
For more information on COVID-19, please visit: https://www.nhs.uk"
https://www.amazon.co.uk/b?node=21103026031
"The last RNS :
This test will be used in the primary care settings, such as GP surgeries and for other professional use and has been subject to successful independent validation by the Liverpool School of Tropical Medicine and St George's, University of London.
No mention of result from this usability study?"
That's because validation and CE marking for professional use isn't a "usability study".
The usability study was required this time because HMG changed the UK-RTC test requirements from professional POC use to self-test at home. This meant the question that had to be answered was 'Can a member of the public, rather than a healthcare professional, use this test reliably and do things like the accompanying instructions make sense?'
If you don't understand this sort of stuff, should you really be investing in these sorts of stocks? After all, the stock phrase is "Do Your Own Research".
"Don't know why mhra have allowed another home user antibody test kit go on sale.Don't know why mhra have allowed another home user antibody test kit go on sale."
MHRA's job is to decided whether or not an individual product meets the technical and safety requirements for entry to the market - and that's it. It has no role in deciding which products, if they meet the requirements, are "allowed" to go on sale.
"Am I missing something?
They announced the completion of the usability study but haven’t published the outcome."
That's because the usability study only concluded yesterday. UofU will have to collate results and publish them formally. I'd suspect either later this week or early next week, by the time it's worked through internal governance and sign off procedures. That will trigger formal MHRA approval.
“ then we would get an RNS tomorrow to say the Ulster test is complete.”
And that’s all you’ll get. No product... just an update.
"Seriously those bell ends think they know more than Cambridge? More than Addenbrokes....they think Addenbrokes is like their GP surgery. Take a moment out you idiots and google what Addenbrokes specialise in. They are one of the leading hospitals in their field in the WHOLE WORLD!!!
Addenbrooke's, the Trust provides emergency, surgical and medical services for people living in the Cambridge area as well as being a centre of excellence for regional specialist services for organ transplantation, cancer, neurosciences, paediatrics and genetics."
I should declare an interest.... my partner is a consultant at Cambridge University Hospitals NHS FT ('Addenbrookes').