Member Info for 1DayRodney

Good read. Seems a lot of burden on further proof and I suppose that depends on how prevalent your chosen target condition is.

Hopefully things may go a little bit smoother for GDR.

We do have the following going for us, but who knows?!

* Full NHS trial results (which subsequently continue)

* In real use with NHS

* NICE recommendation (30/03/23)

* CE-IVD certificated (29/09/21)

* Internationally peer reviewed (22/03/22)

* Partners for FDA application USA trials in place (24/04/24)

As to the current actual progress with the application, we've no idea- it's been 2 yrs since it was first officially mooted!

The next RNS will probably be notification of results which are due by the end of month.

With luck they may also do a live presentation using the usual 'Investor meet company' platform where we could find out what's actually happening with the prospective roll-outs.

The results for SHTG appraisal of the Genedrive AHIL kit has also now been published....

https://shtg.scot/our-advice/genotype-testing-to-guide-antibiotic-use-and-prevent-hearing-loss-in-babies/

Their conclusion is much the same as the ongoing NICE studies i.e. because the gene variant is so rare, further data is required before standard practice implementation (probably down to the relatively low amount of babies being brought into the study hospital with signs of infection)

Thanks for that link Lionel.

I don't if it's been highlighted before, but they (SHTG) seem to carrying out a similar appraisal of the AIHL genetic test also and it too is due to be published tomorrow...

https://shtg.scot/our-advice/genotype-testing-to-guide-antibiotic-use-and-prevent-hearing-loss-in-babies/

I know NHS Scotland Tayside have carrying out routine stroke genetic profiling for the last year or so but I believe they were using lab blood tests.

https://www.genomicseducation.hee.nhs.uk/blog/reducing-stroke-risk-with-a-genetic-test/#:~:text=NHS%20Tayside%20introduces%20UK's%20first,600%20stroke%20patients%20each%20year.

Does anyone know of any evidence that they've now trialled the Genedrive too?

I'd take £2m/share technick 😉😆

🟢🥕 - if GDR were to release £multi k + sales news or FDA approval with USA partner news, 6p would be gone in a flash. Not everyone has a sub 3p average!

We are a long away from any buy outs IMO - GDR needs to be a proven proposition first. I'd be looking more at a future capital raise scenario than a buy out scenario at this point in time.

.

You have to realise (as I understand it) most of the stock here is owned by sticky handed PI's, of which many have averages way above the current price.

I would think the price would need to be much farther north of where it is today to get any buy out approved.

A 30% threshold (approx 159m shares) is relatively cheap to a potential suitor, but the float here seems low, so would need a little time to accumulate and at the moment there's seem little evidence of anyone accumulating such a holding 👀 - but don't quite me on that!

But no doubt, eventually the sale of GDR will be the end game here....

Lionel wrote

"Genedrive POC

https://youtu.be/CmFtVHflLmc?si=TEdl5SrAOxUwPS9x "

That was a good watch, thank you.

The drive to implement POC genomic testing is gaining speed, slowly but surely. It seems there's enthusiasm for it and Genedrive is the pioneer being used to lay the path for the future (hopefully not to the detriment of Genedrive itself!).

Worldwide QA assessment from EMQN will only help prove and give confidence in the technology.

As well as the confirmation that the test is now used in 9 hospitals, the "overall conclusions" slide towards the end shows they are pushing through the AIHL test accreditation to international ISO standards starting sometime last month.

Roger 65

"I sadly ended up being right when I said the sp would drop to 2p by the end of last week. I see nothing, literally, to stop the drop"

You're perfectly entitled to do so but, it becomes a bit of self fulfilling prophecy if you're the one who's not helping by dumping millions of shares. 🙄

"Just sold 499,999 shares at 2p." 

"I’ve got another 1.6m to dump"

Filling the threads with your continual contempt and disdain towards the company is not helping you.

I wish you all the best in your other investments but hope you leave in peace when you're done here. ATB.

Slacker246

"Why would a hospital by a machine if they don't think they're going to need it? i.e if lab testing available"

It's not about 'needing it', it's about improving the care path for a patient and making a more efficient department.

If a patient can be dealt with safely, more quickly, it improves the depts capacity, particularly in an A&E environment.

Like the AIHL test, if a patient comes in with a suspected stroke (or a potential one), then the test can be administered straight away as part of the admission routine and without interrupting the current care pathway. The doctor will then know definitely what the situation is in less than an hour and the patient can be medicated correctly.

It's all about advancement in care with an insignificant increase in cost (if any cost deficit at all).

"Maybe I should give up"

This 👍

Carrot, your inability to comprehend my reply is only matched by your apparent nescience and overwhelming enthusiasm for spamming this message board.

You might wanna pull up them horses a bit there 🟢🥕!!

We need to complete CE-IVD certification first and then get some UK/EU/middle east sales before we can even think about financing an FDA application.

We already have a US partner for the MT-RNR1 kit application. See RNS 24th April.

"Genedrive enters into a Clinical Trial Agreement with a leading multi-state physician organisation for clinical research studies of the Genedrive® MT-RNR1 Product Range in the USA".

This agreement may even

prevent a takeover during this period to protect the partner's investment and may also include a distributor/parent company.

I have no knowledge or know the details of the agreement but would suspect being the US that they have a very 'comprehensive' contract. If not, then the approval with a recognised partner should attract a commercial distribution partner.

If GDR is still independent when it comes to putting the CYP2C19 kit to the FDA, we would likely partner again. However, as I see it this time, only the assay itself would need approval because the Genedrive device itself would have (hopefully) previously been approved as part of the MT-RNR1 application.

In my opinion, based on time, money, established connections and how far GDR are along the regulatory path, it would probably be far cheaper for a competitor to takeover the company rather than develop their own product.

Well, the voting (for this round anyways) is closed and the voting will be officially recorded at 6pm tonight.

So, we'll probably find out which way it went by RNS, hopefully before Friday's court and general meetings.

Be Aware ⚠️

Shareholders' votes on the takeover proposal have to be lodged before 10am Weds or probably by sometime today/tomorrow if you use a broker as your proxy (please check).

It's your voice, so remember to vote - it is your right! 🗳️

I have a slightly different outlook on this.

My view is when the Genedrive test is used regularly, and seen to be reliable, the main lab test will become the test of last resort.

The main labs can then reallocate the current resources used for this particular test to other tests which have to go through the lab e.g. non-genetic marker tests like bacterial/viral/cancer and thus speed up their test results and increase their volume for these.

So rather than being a 'temporary' solution, this POC type test becomes the main method and frees up the lab for other tests rather than compete against it.

The test kit is straightforward to use/implement plus takes minimal space and time to operate. It is also configured to slip into the treatment path and user IT system. It is the way forward for this type of test and will not only aid the patients but allows the clinicians to deal with people effectively and quicker.

It's just my view and opinion, but have a look at the 'directors dealing' tab and couple that with the job offers from Deterra and draw your own conclusions....

Plus, of course, the views/arguments stated in recent RNS and offer publications.

Aww, you missed my winky emoji in your quote lol!