Member Info for roger65

Do you mean 'some short term flow' outwards?

No one knows how long it would take for lab testing to be scaled up but it was stated that it would take ‘a significant time’ To do so. There have also been no estimates given by anyone as to the potential cost.

Addressable market valuations per year by the company for AIHL

Uk £8.5m US £34m EU £46.8m and R of W £13.8m

Customer cost per test is c£80

Addressable market valuations per year by the company for CYP2C19

Uk £8.5m. US £67.6m. EU £93.5m and R of W £51m

Customer cost per test c£100

Mcap of c£100m in another year? Easy

Absolutely not far off affrm. Only question for me is how soon the mcap cd reach £100m and would GDR be taken over before then. Exciting times ahead but everyone invested is I’m sure still a little nervous about the exact wording of the NICE guidance to be published on Wednesday. GDR has worked closely with the NHS in developing the AIHL test over the years and been heavily involved in the DEVOTE funding programme, as well as receiving funds from other Grant giving bodies. I don’t think any of these organisations will want to see GDR go to the wall or be sold to a foreign pharma, which is what will likely happen should GDR not be granted FULL recommendation on Wednesday and not have significant sales of its CYP2C19 test as of Sept.

Full roll out of AIHL in the UK, followed by approval from FdA in the US all within the next 7 or 8 months, as well as sales going in many territories abroad, will put GDR well and truly in clear water and the ship will sail fair for decades to come. Personally I think it will be bought out for in excess of £100m though within the next year. If that happens I and many lths will finally walk away happy, if not a little bruised by the ordeal of the GDR ride over the last few years.

Sorry I’ve again Eureka, I read ‘provisional’ s as conditional. You’re right in that the definition of provisional is the same as Draft. I’ll shut up now. Been awake too long today already.

Eureka - sorry but just to avoid confusion I think the Stroke test CYP2C19 has DRAFT approval, not conditional.

AIHl test was granted conditional approval because of was in EVA process and so couldn’t be given full approval straight away without a lot more data gathering being completed. ‘Conditional’ recommendation (approval) only existed for EVA subjects. If the EVA is being scrapped then this conditional rating will disappear too.

Https://www.nice.org.uk/about/what-we-do/our-programmes/nice-guidance/nice-technology-appraisal-guidance/types-of-recommendation

Looks like there are 4 possible recommendations according to this link that would be relevant to GDR’s CYP2C19 test, although GDR’s MT-MRN1 test received a ‘conditional’ approval due to the fact it was appraised via the newly formed EVA scheme (Early Valuation Assessment - which I think has already been dropped by NICE? ).

84% of assessments carried out by NICE since 2000 have been successful.

1 Recommended

2 Optimised - approved but for use in smaller numbers than originally applied for.

3 Use for Cancer drug fund - Not applicable

4 Not recommend

5 Only in Research.

Obviously GDR want option number 1 but even if it was granted number 2 that would still give GDR some serious income compared to anything it has managed to date.

If you look through the link it also confirms what Stocksaint said yesterday which is that if a product is Recommended then it Must be available to any NHS doctor wishing to use it within 3 months. For reasons of legal liabilities once one Trust uses it then all would have to follow suit. GDR’s AIHL test (MT-RNR1) is already used in hospitals in the Greater Manchester area and in Brighton so once the approval is upgraded to a Full recommendation that will soon have to be rolled out nationwide in order to avoid legal recourse from patients not offered the test. In the litigious focused US in particular this aspect means MT-RNR1 once approved by the FDA will be used everywhere, and the US market value for this was estimated to be worth over $20m (I can’t recall the exact figure but for the UK alone it was £8m).

GDR will soon receive full approval for AIHL and within 7 or 8 months approval from the FDA in the US. Together with sales of CYP2C19 in the UK and the US, not to mention elsewhere eg the EU, GDR will have a mcap of way in excess of £100m…at least 5 x current value.

Yeah but Gino put in £15k and Russ Shaw £25k and neither of them are on anything like Cheek’s salary. Russ Shaw the CFO likely to be throwing away a wedge like that out of choice? Nah don’t think so. He knows or has a very clear idea of what’s coming.

It could also be argued that it would have looked extremely suspect if Cheek, in his first year as CEO, oversaw the sp drop from 30p to 1.5p a put an absolute shedload of his own money in and then watched it fly…? Think he’d have been on the receiving end of a loud knock on the door from someone at the FCA. He was likely advised not to put more in than £10k which for him is a very modest amount. Likewise Gilham, the Chairman. Miele and Shaw were in a better position and so were probably permitted to take larger stakes.

Wednesday we’ll know Prof, Stock and Slacker. Then we can all breathe a sigh of relief that we don’t have to waste any more time on this flipping bb!

Stock is correct on this. It’s also the reason for the delay imho. They can’t make the announcement and have the NHS say ‘sorry, we can’t’ . That’s why they are frantically implementing a ‘resource’. It’s my firm belief that that ‘resource’ is simply putting in place a plan as quickly as possible to get the machines ready for use and train staff in how to use it. It’s a very simple machine requiring just a cheek swab so doesn’t require extensive (or expensive) training programmes for operational use.

This is GDR’s time. I’m sure of it. But you just never know. Only put in what you can afford to lose but I’m super confident if I put in a final £10k on Monday at about 4p I’m going to have at least £15k come end of play on Wednesday. 50% profit in just three days once the markets open first thing on Monday. I don’t often say this but I really do think this is a no-brainer.

An *income of

Effectively yes. At least that would give GDR an off at least a couple of £m a year for one or two years until such time as lab testing is fully implemented. That said, I believe there is a strong chance once the speed and efficacy of the gdr test becomes apparent the NHS might Just stick with it for longer. Don’t know.

This wouldn’t stop other territories using it though and AIHl once adopted in the US nationwide will provide GDr with some serious income and that alone would have the mcap much higher than it is now.

Adverse reactions to drugs costs the NHS £2.2b each year!

The cost of expanding lab testing is also huge. At the very worst I am hoping GDR’s CYP2C19 test would be used for a year or two whilst the saving is made from the adverse drug reaction bill and then the NHS pays for the expansion of lab tests out of that. Takes a year or two longer to get lab testing capacity up but much cheaper in the long run for the NHS and they still get the cyp2c19 tests going full tilt straight away using GDR product.

I would be amazed, really amazed if the NHS can suddenly find the necessary funds to expand lab testing immediately to the required level and don’t use any of the GDR tests. For one thing it would send the wrong signal to the biotech sector in the UK that the NHS, having worked closely with GDR for years, then make a decision that would likely either see the company fail or be bought up for peanuts by a US pharma.

Having said all that, I’ve learned as a long term share holder not to count any chickens when it comes to GDR! My waters tell me it’ll be positive on Wednesday but I’m also half expecting the unexpected. Things are never clear cut with this company and its dealings with regulatory bodies.

Beg pardon, that Q was for Guy Incognito. Obvs NOT anyone called Gino!

Gino, may I ask what you are expecting this week pls? I think, like me, you are a lth and have been largely critical of GDR senior mngt when they’ve clearly got things wrong - David Budd in particular - but now that things have finally been lined up well and going in the right direction, how do you see things working out over the next few months? I’m interested as I take your silence as possibly a nod of approval??

Personally don’t think the herd have arrived yet.

Anyone looking at GDR’s last 2 or 3 years would be forgiven for stalling before hitting the buy button. It’s been fairly shocking tbh. The RF deal seemed to be David BUdd’s parting gift to GDR share holders and I’m still amazed he got that through. I’m always a bit of conspiraratorial thinker and have a nagging question over why he put it in place. Surely someone was advising him and the BODs? They must have known it be hugely damaging to company prospects. I’m still half thinking he was working on behalf of a larger fish /shark that had GdR in its sights and the long term ploy was to devalue GDR to the point where it could either be taken over for peanuts (they certainly managed that) or it wd actually go into administration and someone cd pick up the pieces for even less. My theory continues that Gino and Russ rumbled Budd and manoeuvred him out. With the advantage of hindsight one can see that Cheek has turned things around, albeit more slowly than share holders would have wished, but he’s on the brink of seeing GDR become a grown up little company and hopefully still of interest larger fish/sharks now with some street cred and serious level of approvals behind its products.

All Ona days work of being a GDR lth!

Hope today continues in this current vein of form.

Come on Slacker, pedal faster :)

Earliest date for announcement was July 31st. not before ie Monday

Just a little more patience

No! It’ll be on Wednesday July 31st at the earliest. ffs

Stephen, not in any way attempting to knock your post but do you think the RNS on April 24th was what Cheek was referring to?

April 24th genedrive plc (AIM: GDR), the point of care pharmacogenetic testing company, announces that it has entered into a Clinical Trial Agreement with a leading multi-state physician organisation ("Research Partner") in the USA to support clinical studies required for engagement with the U.S. Food and Drug Administration ("FDA") to progress the regulatory approval of the Genedrive® MT-RNR1 ID Kit into the USA via the FDA De novo submission process.

I still have no idea why they are being so secretive about the identity of this partner, but my guess is BC too. There is history there even though last time it all came to nought.

Hopefully this time it’s going to be a very different outcome.

Hmmm just hope it’s nothing like last FOMO Friday!

No idea if mms are controlling this or holding back or whatever but in some ways I feel a strong move upwards is far more likely on the 31st if we do remain at these levels. If we suddenly jumped further north then I’d be inclined to think there would be a sell-on-news event.

Perhaps staying where we are for now is no bad thing. Just trying to see a bright side…

Slacker has rendered this bb inreadable, which is exactly what he wants. Why?