Member Info for marik

@Rare_Groove, ODX has runway with no immediate urge to fund raise. There are multiple approvals in the pipeline. The DHSC contract states that ODX would not be paying back if the money has already been used (nothing owed). FDA application has been made for professional use. There are a numerous other products (HIV, food intolerance and allergy). Covid is spreading throughout the US and other parts of the world and people are still dying and testing is paramount to help reduce the burden on health cares around the world.

The LFT market is billions of dollars and the ODX market cap is sitting at £14m.

I would like ODX to fund raise to allow them to expand rapidly along with US FDA approval and huge non-UK contracts. i.e. raise money, grow and provide a better return for investors. That is the purpose right?

GLA

@CaptainSwag how does that concern you?

You will find I have postings for ODX before Monday you just haven't looked hard enough. But, I am very touched that you checked.

Thank you.

@TWatcher are you the same TW who wrote that rumour article?

It's a pleasure talking to you @Okehurst1. Always good to have opposing views to provide some balance.

"we knew the USA validation"

@Okehurst1 you knew, but I've realised that there are many on here and many who DM'd me on twitter who claimed that there was no FDA submission made. That told me that some PI's (not all), hadn't quite grasped the positive situation that ODX are in, as such the share price is heavily disconnected and the risk/reward weighs in favour of LTH.

GL

Great so we are all in agreement that the previously held view was wrong. We stand corrected and now know that ODX has submitted an FDA application via Mologic. The professional use test has no cost concerns and the self-test was undergoing a feasibility study (for cost and time).

GLA

@CalderKate, I am shocked that some actually believed that FDA application hadn't been made. Also the confusion between the professional use (no cost concerns) and self-test application (with feasibility on cost on time).

"could be"

Could be anything. As it turns out ODX had submitted for professional use (without cost concerns) and were considering self-test application (with time and cost feasibility). I am surprised that the confusion of the FDA application (as evidenced by the RNS's above) and I'm not surprised the company is undervalued as a lot of private investors have not been aware.

It's amazing how the AIM market works. ODX with an mcap of less than £20m but has the potential to be approved for professional use test in the US via FDA EUA. Surely has to be worth more than that?

"Defo insider getting in… Looks like it could be a government contracts" that would be speculation.

But as I've stated elsewhere, I think there has been some confusion around funding and submission for FDA and clarification today may have rerated ODX accordingly. Reviewing the comments (from LTH) and the RNS's, we now know that:

> FDA application has been submitted for *Professional Use* test for both GAD and Visitect (thanks to Mologic). There are no cost concerns for this.

> Application for *Self-test* was undergoing feasibility for timelines and likely high-level costs

Which leaves ODX with progressing the professional use test (and the possibility of progressing both!). I believe the R/R is very good.

Hopefully that clarifies the situation

GLA

"although I'll agree not in the last 3 days, which appears to be the longevity of your ODX interest."
"Who asked or mentioned your investment history ?"

Slight incongruence? Try not to get personal.

ODX is clearly undervalued if the FDA application has been made already. Todays rise is down to the market readjusting to private investors not having picked up previously that ODX had submitted for professional use (without cost concerns) and were considering self-test application (with time and cost feasibility). This isn't a pump, it's a major oversight by many.

I think there has been some confusion around funding and submission for FDA. Reviewing the above comments (from LTH) and the RNS's, we now know that:

> FDA application has been submitted for *Professional Use* test for both GAD and Visitect (thanks to Mologic). There are no cost concerns for this.

> Application for *Self-test* was undergoing feasibility for timelines and likely high-level costs

Which leaves ODX with progressing the professional use test (and the possibility of progressing both!). I believe the R/R is very good.

Hopefully that clarifies the situation

GLA

"has filed its submission to the U.S. Food and Drug Administration (FDA) requesting Emergency Use Authorization (EUA) for its rapid point-of-care COVID-19 antigen test, for use under both the Omega's VISITECT® brand and Global Access Diagnostics (GAD) brand. "

"filed its submission" = submitted.
"Omega's VISITECT® brand" = Omega's Visitect test
"for use under both" = both GAD and Omega

What do you suggest @Scharnhorst, that they should switch off the lights? If DHSC don't follow through on phase 2 then that has nothing to do with ODX.

The application to the FDA was made for "professional-use test under both the VISITECT® and Global Access Diagnostics brands."

@Okehurst1 who produces the VISITECT® antigen test? ODX or Mologic?

I've stated before, there are two parts:

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.

B. FDA application for *Self-test*:
A feasibility study as to the process, timelines and likely high-level costs associated with the submission of the VISITECT® COVID *self-test* for FDA approval is currently underway, although the cost of gaining approval may be prohibitive.

As the RNS states the professional-use test is going ahead and cost issues are not a problem, and the self-test is undergoing a a feasibility study. So option A is alive and kicking and option B is still on the cards pending feasibility study, in fact ODX could have both a self-test and professional test for the US market if the feasibility study comes back positive.

From 25th Nov RNS:

"Our technology partner, Mologic Ltd, continue to progress their submission to the 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.

A feasibility study as to the process, timelines and likely high-level costs associated with the submission of the VISITECT® COVID self-test for FDA approval is currently underway, although the cost of gaining approval may be prohibitive."

Why did Mologic and ODX make an application for FDA EUA for their test and continue to progress this?

So they could struggle to sell it?

When did he give up? If you are referring to the half year results:

"although the cost of gaining approval may be prohibitive" does not equate to "Colin pretty much gave up on US approvals - too onerous and too expensive."

If you could kindly provide a link it would help?