Cobus Loots, CEO of Pan African Resources, on delivering sector-leading returns for shareholders. Watch the video here.
@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 .
I can't believe some of this written 'publicity' is any good.
I've noticed that in a lot of the articles about the AIHL test that the NHS seem to 'claim' full credit for the equipment and test but the actual designers and builders of the equipment/assay i.e Genedrive seem to a 'throw-away' one word mention! Very few of the articles also mention that the equipment and assay are has gone through a fully documented trial, is CE marked and is commercially available, yet alone where it can be bought from (or weblink).
Frustrating :S
I wondering what news other holders think we should hope for or expect next - the upgrade of the study on Ti02 production, details of take-off discussions or something else?
Also, what do think about potential timescales now that the BOD schedule seems to have slipped?
@Franky
"RNS underscores how painfully long this will take. 2-3 year journey ahead"
There seems to be no definitive mention of timescales at all in the RNS.
In fact, the only mention of 'time' is the phrase "has started an evaluation", which suggest the process is already underway.
The RNS also suggests that the process may have been instigated by NICE hence "grateful to NICE for their engagement" and "pleased that the Genedrive MT-RNR1 test was selected for this programme". Bearing in mind NICE has already completed its Medtech briefing and we've had extensive NHS backed trials, the process may follow a 'fast-track' path.
In the meantime, the test is still available for NHS trusts to purchase off their own backs.
This is the next necessary step to getting the AIHL adopted across the whole of the NHS, which would essentially guarantee GDR's continued operation.
NHS adoption (if approved) along with the current EU trial results (progress?) may also help towards EU sales and the provide the necessary finance to possibly apply to FDA for USA market entry too.
So as I see it, it is a very positive RNS but a lot will depend on the follow-up RNS.
So it's over to you NICE - hopefully the report won't take too long (out if our hands again!)....fingers and toes crossed !!
GDR just tweeted that they will exhibiting at the event...
https://twitter.com/genedriveplc/status/1536653069018071041?t=FHGfw8L0QHAsfEHxOhFmUw&s=19
I doubt any sales related announcements will be made though, but would love to be proven wrong!
~ NHS, GDR & AIHL~
I can understand folks being a little tense waiting for confirmed sales news for the AIHL kit and sales are extremely important, but have a little think about this...
The AIHL assay (with the original Genedrive unit) was CE approved in Nov 19 after which it was given approval to be trialled by the NHS in Oct 19.
The trial, as we know, was a success.
However, a major outcome from that trial was that the NHS asked Genedrive (the company) to redesign certain aspects the Genedrive machine.
Genedrive took onboard their comments and went through the expense of redesigning, re-manufacturing and re-submitting the machine for CE approval.
The NHS also invested approx £900k of tax payers money in the trial and it was deemed important enough to continue throughout the covid pandemic
So,
1. Do you think that the company would have gone through the post-trial re-design etc. (complete with the expense) to the NHS's spec without some form of favourable indication from NHS that there would be 'significant' take up/sales?
2. The Manchester trust(s) have adopted the system and expended time and money training approx 300 nurses. Do you think they will be the only ones in the whole of the UK to have it? Another case of 'post code lottery' maybe?
Most would probably agree that even though we are already 'PHE National Framework Agreement for Diagnostics Goods and Services' approved, trying to get the NHS to make a quick decision/procurement is like trying to push string.
Let's hope IHC are doing the business with regards to UK sales and GDR are with NICE.
~ NHS, GDR and the future ~
I'm hopeful that the AIHL assay can be seen as our foot-in-the-door, so to speak. We now have a successful NHS trial under our belt and also 'the ear' of some influential NHS associates, all of which which bodes well when we wish to trial further assays with the NHS e.g. the stroke drug genetic compatibility test recently mentioned.
If we get AIHL adoption with the NHS 'over the line', I believe the future could be very bright for GDR.
@roger65 re 10:09 posting
"I'm surprised and disappointed none of the London children's hospitals have taken the machines on."
A definitive statement. Do you have proof of this or is this speculation? I doubt anyone here knows yet which NHS authorities have enquired about the product.
"Something else obviously is needed to advance AIHL's potential in the eyes of the NHS."
Again what proof is there of this. The NHS have been positively vocal about the assay including how much they have been personally involved in its development within press and tv releases e.g.
https://www.england.nhs.uk/2022/04/nhs-develops-world-first-bedside-genetic-test-to-prevent-babies-going-deaf/
"We've obviously not sold any in Spain, Portugal, Oman or the UAE in any great numbers or else we would have seen an RNS celebrating the fact"
Again, do 'know' this? You may be perfectly correct but equally negotiations may be ongoing.
"I think Budd may now be holding back on submitting AIHL for US approval because AIHL is proving slower than anticipated in generating income and it's too risky to spend £2m on the application with no guarantees it will be successful."
It is my understanding that FDA application for the AHIL test was dependant on the amount raised in last years RI. The required amount was not raised, so the application will be delayed unless, of course, it is 'sponsored' by a third party.
Also, have you had advanced notice of AIHL distribution figures to back justify your declaration that "AIHL is proving slower than anticipated in generating income"?
Look, this not a personal point about you roger65.
Yours and anyone else's opinions or speculations ("I think, I believe, it of my opinion, IMHO etc.") are all perfectly valid and I enjoy reading them all.
Some are thought provoking and some are just absolute cloud-cuckoo-land and funny but please stop framing such thoughts things as 'facts'.
@stephen11
You are correct about the original article but if you scroll down there is also an update section from 22nd May 2022 entitled "How it is doing"
@jayhayes
Unfortunately it's not a recommendation though!
They are quoting Genedrive (amongst several others) test as being 'expensive' and 'slow' (although the quickest of the comparison tests also mentioned in the article).
The publication seems to be about a new HCV POC test method using LAMP and Microfluidic chips but seems more a test method rather than a complete product. I've not gone through all the other figures (accuracy etc.) and I don't think it demonstrates a direct cost comparison either.
But nothing stands still in science - there'll always be someone who stand on the shoulders of others from before and produce an improved product or idea!
It's about the study of common age related hearing loss and the possibility of genetically re-engineering cells to regain the hearing that was lost, so nothing whatsoever to do with genomic testing or Point Of Care diagnostics.
Stop trying to spook people just because the words 'genetic' and 'hearing' are in the article. An article you yourself implied you have not read, hence the "I suppose" in your post.
@Roger65, I agree with your last paragraph but....
"He’s yet again showing that he’s inept in terms of commercialising any products and his sales team are hopeless too. Such a tragedy that probably another50 babies have been born and then lost their hearing since"
We have no evidence either way for the 1st sentence.
The 2nd sentence is unfair. You make it sound like GDR a personally responsible for babies losing their hearing. The product is out there and in use within the NHS. It is up to individual Trusts as to who now takes up the opportunity until (if) NICE make it 'standard' practice.
IHC results were only up to 31st Jan this year, prior to AIHL launch, so I would not expect any figures at this time. It's only been just over a month since sales were able to start.
However, as Wantmeahouse has highlighted, GDR AIHL does get a specific mention.
Just need the man from NICE to say "Yes!" and there should be no further barriers.
Thanks for the link BurtonD.
That's quite a refreshing and honest outlook from the man at the top.
Only a small investor who's been in since January and had been pleased with SP progress but rather think the drop was overdone today. I did manage a little bit of a top up a smidge above the low point this morning though, so thank you sellers for that :)
Looking forward to hanging around for a little longer and see how this progresses - sounds like it might have legs! GLA
When they say 'all the hospitals' , I believe they are just referring to those within the Manchester Trust. However, it's a positive sign though!
Hopefully we won't have to wait too long for other Trusts to also adopt :)
"Where have you been for the last two and a half years?"
I've been here, money tied up and frustrated with the Covid-96 sales, probably the same as many others.
But how long has AIHL been on the market? Effectively less than one month, yes less than one month! Yet certain posters wanted confirmed national and multi-national sales contracts now - daft!
We still haven't even got the 'required practice' status from NICE yet. The recent NICE report was just the 1st stage.
Sales of AIHL will come and this will be reflected in the SP.
If you've held for 2yrs, you and I both know you had chances to redeem your '£1.50' investment and re-enter lower. If you keep "seeing the same weakness" why have you not de-invested in that time? Probably, the same reason as me...that 'massive potential' you mention.
Look, we all know the products are great but sales have been a real weakness with previous products. DB says they've learnt their lesson - let's see shall we?
Remember, GDR are a tiny,tiny company in this massive sector. What they've managed to develop, trial, certify and eventually market in those two years during a global pandemic shows this company's potential pedigree.
I severely hope that Genedrive's attitude towards sales is better than yours!
You complain about their commercialisation and sales performance and then promptly declare "Forget about the Covid POC kit as clearly no one wants or needs it."
It's only been a few months, jees!
Are you seriously saying you would 'drop' a product so soon after spending all that time and money in research, design and qualification?
Quite bizarre!
Shouldn't you be actively helping the distributors you've established rather than abandon them? This will show other potential distributors you have faith in your product and provide good backup.
I cannot see "Throwing everything" at one product, as you say, is the way forward. It will make Genedrive look extremely one dimensional to future investors (particularly II's) and will make them look no better than say 'a covid' play.
I think a small amount of patience is required here, rather than the constant baying for sales figures.
All IMVHO of course.
I think you'll find it's just because today is the start of a new ISA year, so people are investing new fund allowances.
For this share to maximise AIHL value in the UK market this needs to be 'recommended into clincal guidelines which may take upto another 12mths, so a little patience may be required.
Until then we will only get revenue from early adopters, but this early adoption may help increase pressure on NICE to push it through to the 'recommended' status earlier.
This will then bolster commercial sales in Europe in the near future and hopefully over the next couple of years it will snowball globally.
In a couple of years time the Stroke assay may be at the same commercial stage, repeating the revenue/clinical improvement cycle again :)
I know we're here to realise an investment but who knows, one of us may in the future benefit from such a test. Be it a newly born child/grandchild or ourselves/loved one after an unfortunate stroke. These tests don't just benefit the recipient but all those around them too...
Wolfsbag2 wrote
"Reads to me like once NHS are using even a single device that further assays can be flogged to them for a whole range of genetic linked afflictions (whether existing or still in pipeline) at £80 a pop (or more ?) - is this really as MEGA as I read it ?"
The Genedrive device itself is generic, however it is specifically customised to suit each application/assay. Therefore the same device cannot be used for multiple or different tests, you'll need separate machines.
Apologies if I've misunderstood your implication.