Member Info for RegulatorUK

"Infection cases up, death rate down or low, it is wonderful news for us all."

You're talking bo11ock5!

As has been pointed out a number of times, it is too early to ascertain what the death rate for Omicron is - it will take several months before anyone can say with certainty.

However, the initial signs are not good. The infection rate is very high and it appears that hospitalisation rates are high - most worryingly in younger age groups (although that may be down to vaccination rates). What we know is that if hospitalisation rates are high, then mortality and morbidity rates tend to be high.

"what a load of rubbish CaptainSwag"

Did you expect anything else from him? I filturd him ages ago...

"CK is a liability to ODX….not fit for purpose..
What’s the point of having a good asset but can’t sell it in this high demands environment…
Someone is not doing his job properly….and if he doesn’t go immediately then he is hampering the company success …he must do the honourable thing and depart for the sake of the company and all stakeholders…
He gave the shareholders and the market false hopes repeatedly and no one will trust him again..

Again - do tell us about your vast experience in managing a listed biotechnology company and in dealing with central government during a pandemic.

So far, Colin's not the one lacking credibility...

"The agreement between DAM and ODX, whereby company (ODX) supplies DAM exclusively Is in favour of Company. Company has the right to enter into an agreement to supply its product to any other business."

Is it? I would draw your attention to the wording of the relevant RNS:

" Under the agreement, Omega will exclusively supply its VISITECT® professional use COVID-19 Antigen tests ("LFT") to DAM Health's clinics throughout the UK and Europe...

Additionally, this agreement with DAM Health allows Omega to honour its existing contractual commitments with the Department of Health and Social Care ("DHSC")."

This wording suggests that the exclusivity is in the favour of DAM Health (i.e. ODX will only supply to them for 12 months), with agreement to supply to DHSC if required.

"Great products but managed by muppets…
I am holding from current low sp hoping a change in management and CK removed…and also M/A activity and ODX at this low MCAP could easily swallowed…
Sp is moving in right direction from here and look strong imo.
CK is responsible for many mistakes for the lth misery but luckily I am not one but really feel for you..
GL"

Gosh... do tell us about your vast experience in managing a listed biotechnology company and in dealing with central government during a pandemic.

"Submitted paperwork Sept - no news.
GDR say they have submitted paperwork and expect an answer within 10 days.
Their stock rockets while ours plummets.
Can you see the impact a difference style of PR might have ?"

A rather poor attempt at a deramp - or ignorance of what you're posting about.

GDR have submitted an application for professional POC registration, which is relatively quick (as those who understand the medical devices rules know).

ODX *already has* professional POC registration in the EU. They've applied for HUA - a very different process that takes much longer.

Yes - latest addition is R-Biopharm Rhone Ltd, a company HQed in Germany with a base in Scotland.

Wouldn't be surprised to see further updates tomorrow.

"I was more thinking about the early findings of the Omicron virus being less deadly and the maturity of the virus finding a level where it isn't killing its host."

The are no such early findings. What has been pointed out by epidemiologists is that it is far too early to ascertain the mortality for Omicron - never mind to compare it to other variants. The mortality rate won't really be understood for a number of months.

What is clear is that in southern African countries, hospitalisation rates have shot up - in some places 8-fold. And where hospitalisations increase, we tend to see an increases in mortality and morbidity.

Not really...

The Bloomberg article is based on some analysts' view of the pandemic which are very biased, and many would suggest baseless given the evidence to date. Anyone basing the investment decisions on that 'analysis' need to to get their bumps felt.

"Government has ordered another two years supply of Covid vaccine, this pandemic is not ending soon and testing will become the norm for years to come."

If you check back through my posts you'll see I have repeatedly said the average length of a pandemic is 4-5 years. We're not even half way through this...

An interesting statement from the ABHI around the CTDA process (https://www.abhi.org.uk/resource-hub/file/13042), in particular:

"ABHI acknowledges concerns over the existing validation process for, and the quality of, some COVID-19 tests that are currently being supplied, and support action to remove poor quality tests from the market.

However, implementation of CTDA has disproportionately and unfairly damaged the UK diagnostics industry.

An industry survey of products that were approved, or temporarily listed as exempt from the requirements of the process, showed that three quarters of large companies appear on one or both lists (approved or exempt), but fewer than half of smaller companies appear on either. Only one in ten large companies have no products listed, compared with two thirds of smaller ones.

The confused and confusing implementation of the legislation has restricted the UK supply of COVID-19 tests to a few larger companies at the expense of smaller ones. Smaller companies now feel restricted in their ability to quickly bring new products and ideas to the market. By disproportionately affecting smaller businesses, this legislation has undermined confidence in the aim of the Life Science Vision to build a robust UK diagnostics industry."

I wonder how many of the large companies that got approvals or exemptions have links to the Tory Party?

New CTDA approvals are normally published on a Thursday and Friday. CTDA is under pressure to speed up the approvals process, particularly in relation to those products which have already been CE marked.

I would not be surprised to see something today or tomorrow (but won't feel devastated if there isn't, as I know how htese things can drag on...)

Keep an eye on this page: https://www.gov.uk/government/publications/covid-19-test-validation-approved-products

"Morning first green box pops up full of negativity I would imagine."

I wondered who it was but @GregStottie answered the question:

"Okehurst....what are DAM selling? Its not fresh air."

Seems someone has gone full over to the TWat crew...

Nice World AIDS Day tweet from ODX. Reminding people it's about more than just Covid...

https://twitter.com/Omega_ODX/status/1466068840375271430?s=20

Except that's not actually what the experts are saying... Reuters is quoting an 'unnamed' WHO source (in itself a red flag)and then other media outlets are cherry picking a few words out of context.

What the clinical experts are saying is it is too early to tell. It will be a few weeks yet before data around death rates will be available.

What is clear is that in some southern African countries Omicron has led to a significant increase (up to 8-fold) in hospital admissions - particularly amongst younger age groups.

"Or a company questioning the legality of a contract the day before the presentation. Very proactive."

They didn't question "the legality" of the Contract - they clarified whether the Contract remained in force or not, which is exactly what they needed to do.

The TMS analysis is in line with my views. It's what you get if you remove the hysterics and hyperbole...

"Regulator- Reading my posts, well blow me down with a feather thought you had filtered me ?"

Not sure why you think that...

... you're not really that relevant.

"How on earth can you defend that people invested were being told the absolute opposite of the actual facts"

No-one is doing that.

What we have is a group of people who don't understand how these sorts of companies work, or these sort of contracts operate, speculating about what they have or haven't been told, misunderstanding documentation, over analysing simple statements and whipping themselves up into a frenzy, egged on by people who have an agenda and who, only weeks ago, they'd not have listened to... and we mustn't forget those accounts that only appear at certain times and only post negatively.

Frankly, some people need to take a deep breath, switch off their computer and not look at this share for a few weeks.

"It is simple to show that CEO cant do the job and making very bad for shareholder too. How can shareholder form an action group and request extra meeting to kick him and all BOD off then we are looking someone can command this company . It is all lie and tweet all the time about contact and now they said all Covid contact is gone."

Another semi-illiterate moron to add to the green bin.