Member Info for Okehurst1

Helpful post Dan

Hotel Choc ?

IF we managed to secure a contract off U.K. Government and the Omega BoD took quality legal advice so we didn’t get stitched up again and they can make a decent margin same time / generate cash then that’s a good use of the space at Alva / kit

Omega have kit for 2.6M LFT’s a month
DHSC kit could well be 6M LFT’s a month

Working on 2M a week capacity that Omega advised on - this could be wrong, we need clarification on this point

IF correct, then DHSC kit / establishment take up 70% on a like for like basis - guess storage of inventory comes into play as well

Appreciate it’s a crude method but just to give us some idea of what we could do with the DHSC kit volume wise

Good points TW

Speculating here…

Factors in Omega’s favour ;

- DHSC have £17M of Kit installed at Alva
- Many of the 50 tests below are imported
- Maybe some political benefits

Appreciate we have raised the above before and it got Omega nowhere, however we didn’t have a test cleared anywhere for Home Use before.

Captain, agree on the free tests for the U.K. public
Thinking NHS / Care Homes etc

Captain, new broom with Jag , EU HUA in the bag
DHSC £17M ?

Not a done deal as you say but a chance?

For debate; What we know ( think we know )
Previously discussed

- Mologic Biotech was one the best performing antigen tests identifying Covid 19 up to CT25 according to numerous worldwide independent trials

- Their LFT kit itself however was bottom of a recently disclosed trial that incorporated ‘ease of use ‘ we think this has now been rectified however GAD would have engineered the kit for Mologic not Omega.
Quite possibly Mologic failed at Porton Down as a result of GAD kit not the Mologic bio tech?

- Omega submitted their kit not GAD’s to a User Ability trial in Ulster, which they told us was the last ‘ piece of the jigsaw’ when they submitted the results back in September as part of their EU HUA application

Now that Omega have secured Home Use to the EU we can assume the EU was satisfied that it was suitable for its 440M population to use at Home , as such could we secure Porton Down validation for same U.K?

We have possibly £17M DHSC kit at Alva , Toshiba installed it at DHSC expense ,now that we have test that is cleared for home use EU I wonder if Omega could resubmit to PD but with their kit this time and in their name not Mologics?
Plus we are paying rent on the units housing their Kit

Innova / others secured £1B of LFT orders this month, there is still a requirement for testing connected with public services .

Any views?

Credit where it’s due

This is EU HUA, they can sell manufacture sell direct to 440M people in EU - home use

Avacta via Medusa secured same but withdrew their test - not for this board why

Blu,

We have to look forward now.

Omega are the only U.K. LFT diagnostics manufacturer that has Home Use Authorisation across the whole of the EU and a market of say 440M people and has a test to sell to them today.

Questions about the BoD and their ability to commercialise the opportunity will linger and it would be helpful if Jag could lay out his vision / guidance for the business, but today is a good day for Omega Shareholders, let’s enjoy it.

Marik, good debate

Let’s hope there is some good news in the pipeline nice jump today

Their last RNS on the FDA submission is telling more trial data is required

TW, agree

It is a grey area but experience - costly experience for me - is not to assume anything to the upside with Omega

They thought the EU requesting more information then dealing with that ….. was worthy of an RNS
They told us last piece of the jigsaw

That was 6 months ago next month

Surely they would do the same and advise us via an RNS that everything is now submitted to the FDA ?
It’s as big if not bigger market than the EU

Marik

As Captain said we knew the USA validation was for professional use only - it’s been discussed many times

The grey area ?

Like with EU HUA and the additional information that was required by the EU - being the Ulster trial - when this was completed and filed we received an RNS

The fact FDA themselves have requested additional information as such we should expect an RNS confirming this has been completed but as it stands the last RNS on the subject says the FDA required more information

A. FDA application for *Professional*:
US Food and Drug Administration for Emergency Use Authorisation, for use of the *professional-use* test under both the VISITECT® and Global Access Diagnostics brands. We understand additional US trial data is required in support of this submission and that this is in process.

Marik , this is the same what happened with EU HUA
Yes it was submitted and it didn’t clear , we can speculate it was because a User Ability trial was required

As such like with EU HUA , Mologic and Omega have had to invest in further trials to satisfy the FDA

It’s a choice of words I know but we don’t have a test in the USA that is under consideration according to the info in the RNS above, as like when we were ready for EU HUA which was after the Ulster Trial then I am sure we will get an RNS that the additional information has been submitted

Easy
Look at the RNS below ?

What’s your take ? It’s there black & white

TW, can’t see it

The info on the RNS confirms it

I think it would be worthy of an RNS if it was - like EU HUA

Captain
How long will it take even after submission ?
Who knows ?

A. FDA application for *Professional*:
US Food and Drug Administration for Emergency Use Authorisation, for use of the *professional-use* test under both the VISITECT® and Global Access Diagnostics brands. We understand additional US trial data is required in support of this submission and that this is in process.

It’s not submitted …

Omega does …

But it’s not submitted in the USA

That would be RNS worthy

But still not submitted Marik

That’s the point here … Omega don’t even have test submitted to the FDA , never mind waiting for approval like EU HUA or CTDA - for what the latter is worth

Thanks for feedback Slacko