Member Info for Okehurst1

Let’s focus on the positives here …

No negatives , Omega Visitech are on paper is one of the best - if not the best - Self use antigen test the world by default of Mologic and Omegas engineering diagnostic skills

Granted we need sales but we going into the ( sales ) process with 100M annual capacity and the best antigen test around abs we can offer volume and quality

As mentioned this morning , Colin had to put the capacity in place first, you need to offer volume/ guarantee of supply , Omega offers both.

Let’s look at that TW

PD didnt think at the time there was any difference, this later and arguably more comprehensive study - which is similar to the Welcome Trust study - in identifies Mologic as one of the best antigen tests in the world -

‘Some tests showed impaired performance when using freeze–thaw material and/or Amies media. These findings highlight the importance of understanding assay specific performances and the need to select the appropriate sample matrix and the right test for each intended use, particularly for laboratories and evaluation programs that seek a rapid validation of Ag-RDT using frozen stored samples and ‘off-label’ specimen preparations. The LODs obtained in this comprehensive assessment of analytical sensitivity are consistent with rapidly emerging clinical performance data9,11,37 demonstrating the high clinical accuracy of Ag-RDTs for rapid detection of individuals with high viral loads, which can be very impactful for initiation of isolation and tracing measures’

Without doubt PD’s original specification regarding freezing is now looking flawed.

‘The effect of storage at - 80 °C and one freeze–thaw cycle was evaluated, with eleven Ag-RDTs showing a loss of sensitivity by up to 20-fold. A small decrease in sensitivity has been reported in in SARS-CoV-2 RT-PCR testing (
Nice to see Mologic appears to be the best home test in the world as well, this evaluation was a real boost today, I think we can see why Omega are so bullish

Mentioned Rhodes this morning, converted 15p options into the Tweet fest and sold at 90p
I voted him down, looks like others did the same

ditto Harbison who was in charge of the Tweets
who did the same then left the business with his loot

I am supportive of Colin/ Omega and I hold shares but we have to bring Directors to ‘Book ‘ so the BoD understand this was not good governance

The new non exec chairman looks a decent guy he wouldn’t have given permission for the above shenanigans
for Ref it’s the Chairman who has to pass permission for a Director to sell shares not the CEO

Point made by shareholders today … we move on

This paragraph is quite interesting

‘Six Ag-RDT were not compatible with Amies media and a decreased sensitivity of 2 to 20-fold was observed for eleven tests on the stored dilutions at - 80 °C for 7 days. Here, we provide analytical sensitivity data to guide appropriate test and sample type selection for use and for future Ag-RDT evaluations’

There has been much speculation that PD stored the original Mologic ( and Avacta ) buffer / reagent at top low a temperature

Mologic will understand this and highlighted in advance to PD this time through.

No way on these results that Mologic will not have resubmitted to PD

No reason if these results are replicated at PD that Mologic shouldn’t be a sovereign test
If the Userability trial in Ulster shows the test is easy to conduct (home use DIY ) it’s just down to PD

This comprehensive clinical trial shows Mologic the best overall for Home Use - be it dry Swob or direct culture
This is key as the public can’t mess up the result

EU Home Use has to be when not IF as well

Excellent independent review of all the main LFT test

Well worth a read - published date is for tomorrow

https://www.nature.com/articles/s41598-021-97489-9

Mologic right up there, with the best in the World

‘In conclusion, the most sensitive tests with an LOD?=?5.0?×?102 pfu/ml (˜ 1.2?×?106 gcn/ml) on dry swabs and direct culture supernatant were Espline, Mologic, Sure-Status and Roche’

‘The LOD using dry swab was poorer in all tests when compared to direct culture supernatant with the exception of Mologic, where the LOD was the same using direct culture supernatant and dry swab’

Innova & Orient no where near as good

Mologic / Gates may well just have the best test in the world and by default Omega

No issues with Colin who bought shares @ 53p
the man didn’t take advantage

These 2 directors - was Keiron in charge of Social media ?

Exercising at 15p selling close to 90p into the ‘ Tweet’s

I am giving Colin the benefit of doubt but some of the directors worked it for their benefit ,especially the guy in charge of marketing, naughty.

TW,

Colin had to put in place the capacity - to produce 100M LFT’s a year - before sales of note

Not going to list what that entailed, no argument over this side of things, from a pure capacity point of view Omega are now one Europe’s largest, it’s impressive what he has delivered ( capacity wise) on a £4M m/cap

We have to give Colin credit on this point

We just need sales now and utilise the production facilities in place.

TW
That must be a record of likes for one of your posts 27?

I am still long but fully agree we need to see orders, don’t think anyone can argue with that point.

Not sure if there is anymore research to do on this one, we just have to wait for the orders.

We debated yesterday, don’t think we expected firm news today, suggested timeline/ opinions on thread below.

Colin can’t do much more, he’s done well getting Omega into this position today, but he is now in the hands of others.

Waiting for.

Porton Down … IF Visitech has been submitted
Porton Down , IF not ,its recommended biotech to commence the £374M contract
EU - re submitted , we think 3 weeks to hear
USA - down to Mologic for professional use.

We should secure news within next 2 to 3 weeks on at least 2 of the above, we have waited this long its now very close.

Scardey,

Taking the view if they are going for Home use it has to make sense they target DHSC ? They have £17M of their kit?

Tweet from 25/8/21

CE marking for self-test usage
• We're making real progress in the data submission process (but we can't say too much quite yet!)

#ODX 08/21

Realistically/ probability, they are inside PD

Blubutton
Personal view
End of September/ early October latest depending on how many diagnostic tests are at PD

Scardey,
Realistically that’s my view as well - facts based on known data

Pointless us saying otherwise, it’s there black &. White by the Government

Personally I think Colin has done really well to get it us to the position we are in today, now down to the Biotech within Visitech, again I’ve got faith in Mologic pulling off their bit

Bangbang
This is proper research
Posters are knocking Colin, there is nothing more he can do, the man has done his best, he’s set everything up.

We can’t change Government protocols, it’s there in black & white

It’s now down to PD - for us to be sovereign test
If not we manufacture and make good profits maybe £100M a year

So from PD 4000 person trial it’s back to Oversight Committee /DHSC then (guess) ministers to make the final call

Phase 3
Only if the Oversight Group agrees that a product has passed phase 2 and 2A will it proceed to phase 3. DHSC will advise the relevant manufacturer accordingly and request them to ship at least 4,000 kits directly to PHE Porton Down.

Phase 3 will be carried out against a larger sample set, namely 1,000 true negatives and 200 true positives, which will be sourced by Oxford University Hospitals. The negatives will be fresh samples, transported within 48 hours, the positives will be frozen. This follows recent work at PHE Porton Down to support the development of this protocol which found there to be no discernible difference in performance when using frozen samples.

Additionally, samples from people from PCR-confirmed positive cases identified by the Lighthouse Laboratories will be tested both ‘in the field’ and subsequently by PHE Porton Down. Wherever possible, at least 2 products will be evaluated side-by-side in phase 3 to ensure most efficient use of time and resources.

Phase 3 findings will be reported to the Oversight Group, with DHSC and ministers using this information and any recommendations to inform potential purchasing decisions.

TW
Thought that myself tbh, re read the updated protocol below , it’s pretty clear though.
We are back in PD

TW

So £100M a year profit ? Potentially if full capacity to DHSC?

Where does that put the share price at in your opinion ?

# correction / typo
‘Fair to say it’s going to take a few weeks ‘

Assume we are now ‘inside ‘ Porton Down and we are on week 2 of a 4000 person trial
I have no idea how long this takes but I think it’s fair to say it’s not going to be a few weeks just based on the volume of people required and possibly the multiple diagnostic companies applying same time as it’s a new protocol.

https://www.gov.uk/government/publications/assessment-and-procurement-of-coronavirus-covid-19-tests/protocol-for-evaluation-of-rapid-diagnostic-assays-for-specific-sars-cov-2-antigens-lateral-flow-devices

And following last weeks RNS , same EU validation
Realistically we could be another 3 weeks before we hear from the EU?

Ditto USA via Mologic , no idea but on securing professional use status we can then apply for Home Use ?

Being positive it does look our best chance is DHSC end of the month and in meantime Colin hopefully publishes the Ulster data ?

So not a lot Colin can update us on that we don’t already know, he’s now in the hands of others outside the business?

Does this look a reasonable short term - 2 week -time table?