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In my view the NICE full recommendation, whilst almost certain, is not yet priced in the SP. The recent rise appears to mostly attributable to the FDA news.

What is not priced in the likely involvement of the Genedrive POC test given the laboratory test limitations. In the latest presentation the CEO was very bullish about the CYP2C19 test and alluded to its potential that the company was very aware of. Cheek seems like a very business savvy CEO as evidenced by the PH placing deal and the strategic release of the latest RNSs to shore up the SP. I’d imagine he would release details of or give indication of imminent sales with the NICE confirmation RNS, or soon thereafter - Manshester trusts are a dead cert.

Thanks for insightful posts Jimi. The quotes form the draft recommendation very telling especially: “considerable amount of time and resource required in order to upscale capacity to meet this demand.” As Roger has previously posted, such considerations cannot be overcome in the 3 week delay. The testing strategy to be revealed on 31st will undoubtedly include a POC. ie. Gene drive, component.

Exactly Legalwolf, Cheek was very optimistic about CYP2C19. But you don't have to take his word for it; look at the competitor product by Genomadix Cube. The Genedrive test beats the Genomadix Cube on every level - that's undisputed.

I don't believe it's a public company and I can't find much financial information about them. However, this source suggests that their 2023 revenue was $12.5 million: https://www.zoominfo.com/c/genomadix-inc/563623776.

Thanks Cubeinvester. Yes, I check the BB in between working and I must say the name calling and tit for tat comments can be annoying. ( Although, someone posted a link here which highlighted that even those juvenile and amateurish posts may sometimes have well-organised sophisticated people behind them).

I think all the available relevant information regarding NICE and the CYP2C19 test has been posted and linked on this board. And naturally rampers and de-rampers are trying to spin it to suit their interests.

It is correct that the expected NICE recommendation is not solely about the Genedrive test per se. Rather, it is about whether there should be testing or not and what form that should take.

I think the two best sources to objectively understand the situation in the company's latest presentation

(from 22:24 minutes https://www.youtube.com/watch?v=gUjy3cAjV5M&t=2136s) and the Draft NICE guidance itself.

There is nothing that has come to light, in the public domain or privately to the company - which it would have to disclose to shareholders if it would make a material difference, to suggest that the final recommendation will be any different. So what did the Draft guidance say? It said that the lab based test should be used. But if that was not available then the Genedrive POC should be used.

It must be understood that currently the 7 genomics labs do not do any CYP2C19 testing (listen to the presentation and read the consultation docs). It is not a question of them ramping up testing as suggested by some, but rather delivering a new test and service from scratch. Currently, even the most ultra rapid, urgent genomic testing can take days. This is against NICE advice to start clopidogrel within 24 hours.

Full recommendation will mean funding will be made available for the tests and commissioners will be able to order the tests. The draft guidance clearly allows for commissioners to use the POC test instead of lab tests due to unavailability or unfeasability of the lab test.

Confirmation of the draft guidance on 31st, will realistically result in orders for the Genedrive test by the NHS and open up the likelihood of international orders also.

In my view, the SP at current levels does not reflect that likelihood and potential and therefore there ought to be an increase in SP with the confirmation. I'll leave it for others with more financial knowledge to critique what the SP could be. My lay opinion is that a MCap of 50-100M (9 -18p) is not unreasonable.

Hmm, I think 20p (110M MCap) in only likely if along with the confirmation of full recommendation, there is an RNS for sales. I don't rule that out as I think Manchester is highly likely to adopt CYP2C19 testing from GDR.

Btw, something else about the tests that is overlooked by people is that the lab tests require a blood sample whereas the gdr test is a single buccal swab (or should that be Cheek swab!). In actual practice, the advantage in convenience and reduced safety risks to staff and patient is massive.

The reason GDR first focused on AIHL and then the stroke test is that obtaining a diagnosis in these cases are time critical. 1 hour for AIHL and 24 hours for CYP2C19.

7-14 days just wont do! That's our USP. No clinician would ever be prepared to wait for days when he could confirm the diagnosis in an hour! There is no way on earth that genomic hubs will be able to compete on timing with a bedside POC test. (And our CYP2C19 test is cheaper to boot - the clinician is happy as is the accounts manager).

I agree Stephen 15p would equate to a market capitalisation of only around 80M. That's next to nothing for a company with unique products, and clear and imminent revenue, not to mention the IP and its potential future use (eg. tests for antidepressants effectiveness etc.)

It should be clearly understood by investors, that the possibilities of future tests are massive. (just google which drugs are metabolised by cytochrome p450).

"if possible"

Last paragraph of page 5 (this is the committee's summary rather than individual opinion):

"There are likely to be considerable barriers to implementing laboratory-based testing for everyone who has had an ischaemic stroke or TIA. If laboratory-based testing is not available, or it will take a long time to develop capacity to provide it, then point-of-care tests could be used. So, the Genedrive CYP2C19 ID Kit should be used when laboratory-based testing is not available."

Some are dwelling on all the possible negatives rather than being objective.

Reading the draft guidance, at the bottom of page 5, the 3rd bullet point states that the Genedrive Kit

• is cheaper per test than laboratory tests and the Genomadix Cube.

At page 4 it states:

When implementing testing, commissioners may wish to consider:

• point-of-care testing as an alternative if laboratory-based testing is not feasible at this scale, or while capacity for laboratory-based testing is increased.

That's exactly correct BigAl. Lab test cannot be an alternative to our AIHL test because of the critical 1 Hour time period in which to administer the gentamycin.

NICE guidance for CYP2C19 testing in IS/TIA is 24 hours. There are currently only 7 genomic hubs in England.

Here is a link to a page from one of these hubs (North Thames - the same trust running the workshop in September):

https://norththamesgenomics.nhs.uk/genetic-test-ordering/turn-around-times/

You will see that their fastest "urgent ultra rapid" service has a turnaround time of 3 days! Other "urgent" tests take 7 to 14 days. You can see why they’ll be relying on our tests. This seems to the same situation nationally.

I highlight this because some posters are saying that although FULL recommendation seems to be in the bag, lab tests will still be preferred. But realistically, the lab tests just can’t be done in the required time frame. IF we get full recommendation, 8.5M annually is pretty much guaranteed.

"12p would be about 66 million mcap. What justifies that?"

A: an annual revenue of 8.5M from one test alone in one country.

Thanks Latentvalue, a good pragmatic and sensible post.

Fantastic find Lionel! This is great, it shows that behind the scenes NHS trusts are already gearing up to implement CYP2C19 testing. Also, North Thames are not one of the ones currently using our MTRNR1 test - indicating that the CYP2C19 test will be used more broadly - across the wider NHS?!

This is great; roll on 31st July!

That's a nice top up Lionel - given what's still to come, that will be viewed as a very cheap price in two week's time. I've been doing lots of last top ups over the last month!

You’re right bighammer, maybe I should be dreaming bigger! Indeed, reading that RNS, it suggests timescales will be reduced from the previous expectation.

What’s more is that this is not just a flash in the pan Covid opportunity - as we dreamt of before!

Indeed a very good day! Now that the day traders have disappeared we can reflect more soberly.

Although, it may not have come as a surprise to LTHs, the RNS is very welcome news. This effectively de-risks our FDA application. This new status means the FDA will hold our hand and walk us through the process, with no surprise rejection or more evidence needed at the end of it! Plus it will be quicker. And because the USA doesn’t have a cash strapped and short-term-thinking NHS bureaucracy, in due course, we’re near enough guaranteed 30M a year for our unique test.

The AIHL was why I invested in GDR those years ago - it just seemed a no brainer. No we’ve got 2 no-brainer tests. In a couple of years from now, we could be earning around 47M annually (8.5 UK, 30 USA, plus 8.5 UK for stroke)

For the first time, I can genuinely see GDR being bought out for 100s Million in a year or so.