Member Info for 1DayRodney

# NICE can assess it.

We should have other news to come around early new year when the stroke assay lab tests are finalised and it CE certified. I believe this is required before NICE cannot assess it. The NHS/NICE are expecting to receive the kit Q1.

Therefore Q1 is looking very key for us, especially with AIHL receiving final judgement too!

The agm minutes will be publishedby RNS and should also be in the investor section of GDR website.
Yoy can then vote on each resolution usually by using your broker as a nominee e.g.

https://www.hl.co.uk/help/dealing/corporate-actions/how-can-i-obtain-company-information/how-do-i-attend-andor-vote-at-a-company-meeting#:~:text=If%20you%20wish%20to%20attend,by%20secure%20message%20or%20post.

HTH

This is in a similar vein to some previous postings.
But I think the fundamentals of the AIHL product's potential are being severely undermined here by the damning performance of failed sales and false horizons created from comments and predictions made by the CEO and company presentations.

However, remember that although we provided the kit and support, the AIHL test is basically the NHS's baby and this could be our lifeline.

? NHS Approached GDR for the test.
? NHS Allowed the test trial (PALOH) to continue throughout the pandemic.
? NHS consultants ran the trial (not private sponsors) using NHS staff and money. They (not GDR) produced the peer reviewed paper.
? The publishing of original paper & NICE assessment review were deliberately delayed so that an internationally known periodical could publish it at the same time.
? The consultant who ran the trial has repeatedly appeared at conferences promoting pharmcogenetics by using the PALOH trial as an example.
? Repeated press & social media releases by the NHS highlighting the test

https://twitter.com/NHSgms/status/1557622852496637953?t=eOEmiOBB7Ai9fy9yKy4lnQ&s=19

? The test continues to be used by the Manchester NHS Trusts (at the least), so the is still proving its worth and providing further data validation.

? NICE have taken it onboard to assess whether to make it 'best practice' and have now accelerated the process to finalise its decision 7months earlier than first stated!

With all this, I find it hard to believe that the AIHL kit will just fade away to nothing.

I understand there are approx 100+ maternity facilities across NHS England. Each would require more than one Genedrive.
It's a 5 month wait but if we can get it over the line with NICE, it will be a true winner.
It should lift the SP micely and provide the £s required to keep GDR on the road rather than milking us poor PI's (again!).

We also have a reputable distributor on board for this and are not soley relying on Mr B to promote it.
I agree that non-uk sales need a rocket but if adopted by the NHS, it should prove a powerful sales advert as well as providing a potentially life changing service.

The NICE assessment page has been updated accordingly

https://www.nice.org.uk/guidance/indevelopment/gid-dg10057

Reason for Early Value Assessment (EVA) quoted as:

"Anticipate the topic will be of importance to patients, carers, professionals, commissioners and the health of the public to ensure clinical benefit is realised, inequalities in use addressed, and help them make the best use of NHS resources"

Sounds encouraging.
Just hope it's not another false carrot!

Thanks for the link.

I'm probably alone in this thought but...

How do those interested in the products or investment perceive the company if its own shareholders respond to every Tweet from either GDR or a third party linked article with a barrage of negativity and sometimes outright abuse? What positive purpose do the Twitter posting shareholders think it serves?
I mean nothing personal by any of this, I just don't get it.

I get the attitude. I'm 'pi88ed too at the way the company has commercially performed, private investors have been treated and the CEO/BOD has acted. I shall probably be voting for the first time at this year's AGM (bar a miraculous sales report!).

I also agree everyone's entitled to a voice - email, DM, at the AGM or on other platforms, like this one etc., hell, form a shareholders group but 'washing your dirty laundry in public' on such an open social media platform can't surely help our situation can it? Or am I missing something?

All IMVHO

Get your finger out MR B and GL all holders!

Sorry Jay, don't have LinkedIn account, what does it say?

I was reading the the 'final scope' document for the NICE assessment. Interestingly the Genedrive is being compared to a lab test and another piece of kit from a Canadian company called a 'Genomadix Cube'.

In the document comparison table it shows the Genedrive (potentially) detecting more relevant genetic markers than the Genomadix system. The Genomadix assay also has to be stored at freezer temperatures (as opposed to room temperature for Genedrive) and only has a 15min 'best before' time.
I say 'potentially' because the Genedrive assay is not planned to be available to the NHS until after Q1 2023, so NICE must be keen to assess it to wait fir the development phase to be completed. Guess all the science/tech elves are working their hardest to meet this timeline.

I would therefore (hopefully) expect a trials result/CE marking RNS sometime early 2023 - approx 4 mths away.

Be interesting to see what Mr B has to say about it in the end of year results due in about 6wks time.

Another dangling carrot no doubt, if further funding is required :S

The same NICE project leader is also assessing the CYP2C19-ID stroke test which is due for publication mid Aug 23.

The Scope document for this appraisal is already on the downloadable documents list.

https://www.nice.org.uk/guidance/indevelopment/gid-dg10054/documents

So I wouldn't expect any shift in the AIHL appraisal timetable.

Don't forget, unlike the stroke assay though, the AIHL kit is on the market and available for purchase in UK & EU.

Late next summer really will be key for GDR.

Well on the NICE webpage they have already marked the Scope document as 'published' today, but the rest of the 'provisional schedule' timeline currently remains the same.

https://www.nice.org.uk/guidance/indevelopment/gid-dg10057

The 'scope' is not listed amongst the downloadable documents (yet?).

Re the link posted below:
Quote -
"Thomason is also optimistic about Futura, which is making a gel for erectile dysfunction."

We could with some of this on the share price lol!

Thanks for the link but unfortunately it means little until the Thackers Pass mine gets a favourable decision from the Nevada courts and actually commences. The judge has been deliberating for over a month now while we patiently wait.
Nevada is vast but with a sparse population of less than 3m. As a comparison, the UK would only take up about 85% of the land but this one remote disputed 'historical site' seems to be a real sticking point.
Even now, opponents are readying their next move.

https://www.earthisland.org/journal/index.php/articles/entry/opponents-of-nevada-lithium-mine-thacker-pass/

As investors, we hope it gets the go ahead, taking this company to the next level but we aint there yet... Keeping fingers and toes crossed!

The AIHL NICE guidance committee should provisionally be moving to the next step on Tues 20th by publishing its 'Scope'.

This may give us a better idea of how the kit is to be assessed and what criteria NICE need in order to recommend it as 'best practice' and may also firm up any future dates in the process.

https://www.nice.org.uk/guidance/indevelopment/gid-dg10057

In the meanwhile we can only assume that is being actively used by the Manchester Trust still here in the UK.
It would also be interesting to know how the EU trials went and if they had the same positive effect as the UK trials did.

I wonder if any GDR update is being timed around this?

Here's an interesting recent article from NBC News which goes the appeal story and gives views from those tribes and locals who both oppose and are in favour of the mine.

https://www.google.com/amp/s/www.nbcnews.com/specials/the-cost-of-green-energy-the-nation-s-biggest-lithium-mine-may-be-going-up-on-a-site-sacred-to-native-americans/amp-index.html

It seems we aren't the first to be assessed by NICE for a similar assay with a POC device. Another company has recently (2020) had a NICE MIB assessment

https://www.nice.org.uk/advice/mib223

Although it's expensive at £10k per machine and £175 per test (originally quoted in another doc).

The released device has just been approved in Canada using a cheek swab.

https://www.prweb.com/releases/2014/10/prweb12276814.htm

However, as with almost all med-tech there'll always be some competition somewhere and this may have no bearing whatsoever on what GDR may offer.

Both this NICE assessment and our AIHL assessment are due to be published near the same time next year - could be an interesting Aug/Sept 2023!

Mr & Mrs Incognito:
(Panicked parents) Will my baby be ok doctor!!?

Doctor:
I'm sure little Timmy/Tammy will be fine after a dose of antibiotics. There is however a chance they could go profoundly deaf for the rest of their life and will need electronic implants to ensure a 'hearing' life.

Mr & Mrs Incognito:
OMG doctor! So I have to decide whether to risk Timmy/Tammy's hearing in order to save their life? Wow! Well no question really! Antibiotics it is!

Doctor:
Well there a cheap and quick test available and developed by the NHS that tell us if we need to use an alternate antibiotic. This will just about guarantee Timmy/Tammy will get better and retain their hearing but here at Saint Save-a-Penny Hospital didn't think it was worth the £4,068/yr just to save 5 or so potential children born here each year the inconvenience that they may have to have a lifetime of medical hearing care, even though we probably spend way more than that making sure the garden and reception plants looks nice. So fingers crossed then folks!!...

Mr & Mrs Incognito:
That sounds like a very sensible financial decision to me. Nevermind, good luck Timmy/Tammy!!

(entirely fictitious scenario and characters. Any similarities to any event or person is purely coincidental)

Not everything is about saving £s (albeit not an inconsequential £5m). Just to remind you, this says what it really means to people..

https://youtu.be/eELuv69pRnk

The NHS provide many, many services, OT, palliative care, cosmetic surgery, IVF etc. etc. all which cost with no return except quality of life.
Remember, the NHS have told the world that this is their test!
As frustrating as it is waiting for the golden goose (NICE) to lay the golden egg, we'll just have to wait it out.

@jay
Even if they have sold their direct investment in GDR, it doesn't prevent their charities from purchasing GDR products.

@roger65

Re your comment yesterday about DB - "Budd won't be selling anything. He's a scientist isn't he?! "

His career path appears to have been in marketing and management, so you would have thought commercialisation and all that involves would be 2nd nature...

https://uk.linkedin.com/in/david-budd-28a25612

@systemzero

I understand it, the NICE timetable for the AIHL guidance appraisal is published here...

https://www.nice.org.uk/guidance/indevelopment/gid-dg10057

The study's remit is published in a document found here...

https://www.nice.org.uk/guidance/indevelopment/gid-dg10057/documents

So a decision from NICE based on your timetable looks (at the moment) a little premature.
I stand to be corrected and I hope I'm wrong and it is sooner :)

However, as has been said here before, NHS trusts do not have to wait for this guidance. They are able to purchase the kit now if they wish, so you may indeed get some sales news by end of Q3.

I read several posts recently about needing to get AIHL to the US, incl roger65's today .
I believe a cost strategy for this was put forward by the BOD at the last autumn's Placing & Open Offer -

RNS 10th Sept:
"The US market is considered to have an attractive legal and clinical landscape for the Group's AIHL assay but any launch there would require FDA approval. FDA approval and US registration is not funded by the Placing however, should the Company raise a minimum of £8 million via the Placing and the Open Offer, the Company's intention would be to accelerate the commencement of US studies, and expects that £2 million would be the total cost for the FDA submission and approval process."

However, by shareholders not fully subscribing to the Open Offer, we did not achieve the required target.
Maybe this has now come back and bit us in the a$$.
The last raise price was a body blow (40% discount!) but that lack of subscription (£3.4m short I believe) has inevitably resulted in a delayed FDA approval application .