Member Info for Computer909

@Sharebel: In reality no one knows what they will do, we will all find out in a couple of weeks i suppose.

@Sharebel: "under the EUA regs a report has to be made one year after in order to carry on use under EUA "

Worth checking out the DHSC's opinion on that

https://questions-statements.parliament.uk/written-questions/detail/2021-06-14/15211
https://questions-statements.parliament.uk/written-questions/detail/2021-05-24/6254

@Gman753: The DHSC contract allows for 8-11 weeks for Tech Transfer of any test after it has been selected and phase 2 demand raised, (But as you know ODX haven't really covered themselves in glory with rapid tech transfers recently !)

The government though seem in no hurry to make a test selection, realistically they have placed themselves and ODX in a crappy position, whilst the free issuance is maintained and the numbers needed are still beyond the UK capacity they have to continue to buy from the Chinese suppliers.

They really don't want to be using multiple suppliers for sending out to Joe public with different instruction etc, its taken months for people to get used to the innova tests, and if they start getting a different test through the door each week, there confusion will be catastrophic, so they stick with what they know and whilst they aren't as good as others they are now the accepted norm.

There are three main streams of LFT use in the UK at the moment (or were before schools broke for the summer), Health professionals and Social care, Schools and Colleges and the Joe Public free issuance. They look to have targeted Orient Gene to the educational settings, so that leaves Health and Joe public, I expect Joe public free issuance to be withdrawn (and hence the new approval rules for private sales), and I hope that then leaves Health Care which the government will switch to the UK sources test, when stocks get depleted, but this is probably into 2022 (based on the usage figures and published supply numbers)

This is why Visitect sales is so critical for ODX

@Sharebel: "The terms of circumnavigation of using emergency use contracts cannot now apply here as they have contracted a contingency and new provision with us"

How is that any different on today than it was on the 27th June when they extended it last time ?

@GMAN753: You need to consider that position the MHRA have put themselves in, they have publicly stated:

"Our priority is to ensure patients and the public have access to safe and effective medical devices and tests. Following our normal process to investigate any product concern, the MHRA immediately began reviewing all available information. A full risk assessment was undertaken by DHSC as legal manufacturer of the LFDs in the UK and the MHRA has undertaken a thorough review to ensure that we were satisfied with the assessment and any action proposed.

We have now concluded our review of the risk assessment and are satisfied that no further action is necessary or advisable at this time. This has allowed us to extend the EUA to allow ongoing supply of these LFDs over the coming months. People can be assured of the MHRA’s work to continuously monitor the tests in use; as is our standard process."

So if nothing has changed with the test and the disease, there would be no reason to not renew the EUA if the DHSC requests it, and whilst they have stockpiles of the test already paid for, the DHSC will obviously request it.

The only change will come when the DHSC decide to stop issuing free tests to the general public and instead limit them to health professionals

"The EUA for Innova expires on the 28th August - What then ?"

It will simply be extended, there has been no significant change (apart from the further adoption of Orient Gene) that will give the MHRA no option other than extend it.

Konsung and Goldsite both Chineese manufacture

From the ABDX information released today its clear that at the beginning of the pandemic the government were running around like headless chickens, throwing around figures for antibody tests in the order of 10M and even 40M, its clear that this drove the formation of the UK-RTC, as ABDX stated no single UK manufacturer was positioned to supply that many tests at that time, So it was ABDX that drove the UK-RTC formation rather than the government or John Bell.

ABDX were clearly operating in good faith, they have said they sidelined two other projects to respond to the governments "call to arms" but the DHSC have shafted them royally, I have no fear they will get the payments they are owed from the DHSC (How can they refuse if they have used them for the job they were purchased for), but the GLP seem free to shout unsubstantiated crap from any rooftop they want without the fear of any legal retribution.

Interestingly we do now have some figures for what the government was expecting to pay for antibody tests at that scale and even the some figures around how much royalties ADBX are expected to pay the DHSC for sales to third parties

The ABDX statement at the end of the RNS

"That we have been caught in the cross-fire of a battle over transparency and accountability, which has meant this British developed and British made rapid diagnostic has not been substantially deployed here in the UK."

Clearly indicates they feel that it is this case that has help back government orders for the test

“Please tell me Omega will be manufacturing their tests -“

Flowflex is an Acon labs test, manufactured in china

https://www.aconlabs.com/about

“Nothing positive to say, computer?“

We aren’t in the 40s !!!!

“and who has a govt contract to manufacture these LFD's?”

Surescreen?

“how many lateral flow tests for covid-19 are available for (a) August, (b) September, (c) October, (d) November and (e) December 2021.”

“The Department is unable to release this information as it is currently being used for the formulation of government policy on lateral flow testing”

Surely the government policy should define how many are available not the other way around, looks like the policy is defined by how many are left to use up

"I'd be more concerned if those directors were actually leaving the company which clearly isn't happening."

Exit Kieron Harbinson, stage right !

"Personally I think it's to speed up wrapping the stuff they are making for a 3rd party on behalf of HMG"

When I queried Wallbrook about the new equipment it got back

"The original equipment provided by the UK Government on loan allowed ODX to be able to produce cassettes for LFTs via a manual process, this is set up and there was no failure by ODX to meet any deadlines as part of the contract. This new equipment now allows this process to be more automated."

Personally i thought this a little worrying, as we had led to believe the company had the capacity to produce 2M test a week in April, and to produce 2M test a week (working 7 days a week 24 hours a day) they need to produce over 3 test a second, a challenge for any process that involves any manual input. Multiple lines maybe based on the inventory list (https://questions-statements.parliament.uk/written-questions/detail/2021-06-04/10268) but only one additional automation machine.

"and if this deal is gone what is happen to share price?"

Supposedly the company has considered this possibility

https://www.omegadiagnostics.com/Portals/0/Omega%20Diagnostics%20Group%20plc%20Annual%20Report%20and%20Group%20Financial%20Statements%202021.pdf (Page 27)

At least they are comfortable they can keep paying Colin and his cronies until 31 July 2022, even if they have to use the overdraft !

To reiterate the governments support for UK manufacturing they have dispatched another critical piece of equipment to ODX as part of the DHSC contract (Expect another its legit tweet from Colin later today!)

https://images.app.goo.gl/85b7acMB8B6aTE6w8

This is coupled with another Job advert from ODX for a skilled operator,

We need someone to keep the cobwebs away

@Gman753: why would they buy on the open market when we keep giving them at a knocked down rate as options

@Gman753: Don't get me wrong, if individuals are awarded options no one can blame them for making the most if them, the issue i have is that ODX seem to be expecting its investors to me paying a large proportion of directors remuneration rather than paying them out of generated revenue,

This approach is all well and good if the company supports the shareprice, but ODX investors are seeing the double wammi of the share price collapsing and option after option being issued,

@Gman753: Usually with share options you would expect these to be a reward for the success performance of the company, ODX seem to be in the mentality that the directors deserve a reward from its investors for actually achieving nothing, keep in mind that any share dilution is affecting the value of your holding, since april 2020 Omega have extracted nearly £16m from the market, and are yet to justify that investment.

By way of illustration of ODX activity in the Options, look at the following page

https://find-and-update.company-information.service.gov.uk/company/05017761/filing-history?page=1

Each one of those allotments has an impact on investor value, and for what?

With regards to expected news, and new timelines, this is the feedback i have from Walbrook today

"Omega provided an updated timeline in their recent results statement and said that they planned to submit data from the study to their Notified Body by the end of July and explore how they can fast track approval – they have not provided any specific new guidance on when that approval would come through. They have begun that submission process and are running the review and evaluation process in parallel to ensure timelines remain on track. When approval is forthcoming ODX will update shareholders."

When asked if they have sold a single own brand test yet:

"Omega would need to provide any update on product sales via RNS rather than to shareholders via email, if there’s an update on the commercialisation of the VISITECT antigen test beyond what has already been stated in the results RNS and presentation then they will provide that. As you will have seen the company has said that they are seeking self-test approval, are seeking FDA EUA status to be able to sell in the US and expect demand in Q2."

"Jag Grewal will focus on Health & Nutrition and John Bannister, Global Health Business Development Director, and his team are responsible for the commercial roll-out of COVID-19 related products."

So its John Bannister (@banny204) that has taken over the poison chalice, of looking to remove the "Couldn't sell a test in a pandemic" reputation from Omega. Lets hope he's more switched on than his predecessor