Member Info for Muminr

I don't know about 2030 roger. Give it's a non invasive diagnostic test with huge upside and no obvious downside, the requirements shouldn't be that stringent I would have thought.

I remain confident that full approval of the AIHL will materialise soon. Unlike others however, I am not as optimistic on the Stroke Test.

It seems absurd if NICE did not inform GDR, only giving conditional approval not full and not stating why or what could be done to remedy that.

Like you bighammer, I was convinced that the clear health and economic benefits would result in wider adoption despite a conditional recommendation. It appears not to be the case.

Yes, GDR must know. The fact they haven't shared the requirements and the poor share price suggest they are onerous.

@ Jo Bloggs, I don't think your prediction of full approval for AIHL within the next 2 months is unrealistic.

@ Starresentoff, your 18 months prediction is pure speculation and the mention of 3-4 yearly review is also agenda driven speculation. Don’t forget the EVA is an entirely new regime designed to speed up access to diagnostics!

Full approval could be as early as October. The PALOH study was conducted in 11 months, between Jan – Nov 2020 across 2 sites with a sample size of 900. The results obtained gushing praise from all quarters of the NHS and conditional NICE approval – the best outcome in the circumstances.

Yesterday’s article states that there are at least double the number of sites and a sample size of 1700. Accordingly, similar data could be reproduced in half the time.

I don’t know exactly what was required in terms of further info but I would have thought 6 babies saved from deafness and same number of results replicated in real conditions are more than adequate.

Starresnstoff, good to see your return to a more balanced post. I agree, FDA would be a real catalyst to the SP.

However, at least AIHL may not cost anywhere near £2M. We’re of course waiting for news of that confirmation which may come at any moment. Indeed, it is overdue.

Yes, unfortunately the NHS monolithic structure makes it a difficult market to sell to but I’m not sure the rest of Europe will be as difficult. I must confess I am disappointed in the NICE outcome for AIHL, although it was the best possible outcome given that evaluation regime.

I am personally aware of the huge interest in AIHL at consultant level and am convinced that following the current data collection a NICE review could happen in around 6 months. Cambridge University Hospitals Trust have had a demonstration of the test and are very interested, but funding and best practice status is the issue. We’ve all seen the congratulatory hype from all levels of the NHS and I’m sure NHS bureaucracy and inertia will be overcome for this product.

Thanks bapuk. I was not aware of this. It could really assist GDR and it shows to be false those on this board who aver that no funding is available for those trusts that wish to purchase our tests.

That's great Executioner, the nurse did confirm they were getting results in 26 minutes. This addresses one of my last doubts about the test - that in practice nurses may not be able to conduct it in good time.

No self-respecting clinician will ignore this test. There simply is no plausible reason why this will not become best practice very soon.

However, 2110 subscribers who are likely to be professionals in the field.

Many thanks for the posts Roger. I must say I like your long and reasoned posts.

I don’t think it’ll be that long a wait. I agree we might see “further guidance…in the coming months” on AIHL. Otherwise, what is the point of an Early Value Assessment if it just results in kicking the test into the long grass for 4 years!

Other trusts will also take up the tests as it really is a “no brainer”. Cambridge University Trust have stated to me that they “plan to make the test available in the future”.

Of course, FDA news and or overseas sales could be announced at any time.

The CYP2C19 test beginning the NICE process will likely lead to renewed interest and a SP increase as that is a much larger and established market.

I am in it for the long haul. However, I do not think it’ll be that long and I will add more if the SP decreases significantly in the coming weeks.

What are your thoughts on how to vote at the AGM?

I have benefited from your research and posts in the past starrensstoff which is why I went to the report. I did find the report to be positive and I couldn't find any negative takeways.

Thanks for the tip starresnstoff. I found the report balanced and reassuring. Were you thinking those invested would be too lazy to register and read the report?

How about this under Outlook, only positive here also:

Outlook.

Over the balance of the 2023, we expect to see widespread adoption of the MT-RNR1 test in existing launch hospitals. In addition, we expect genedrive to (i) sign additional distribution partners for MT-RNR1, (ii) establish additional sites in the UK, (iii) launch the MT RNR1 assay in other EU countries and (iv) launch CYP2C19 in the UK. NICE is also expected to complete its review for Genedrive CYP2C19 and launch in other territories subject to IVDR registration. We also expect a response from the FDA as to the Pre-Sub application processes for MT RNR1, which will determine how to proceed (funding permitting) to access the large US market.

Here it is, nothing negative at all in my view, quite the opposite:

GENEDRIVE (GDR): CORP Interim results and up to £5m funding

Half-year results to December 2022 reflect a period in which the company continued to transition to its two new point of care (POC) genetic tests. genedrive reported revenues of £21k (vs. nil) and an adjusted net loss of £2.7m (vs. -£2.8m, -4%), with cash of £2.1m at the end of the period. Cash at 14 March, following a £0.96m R&D tax credit, was £2.0m, which together with a c.£2m investment (as part of up to a £5m funding package), provides the company, based on the current £0.4m monthly burn, with a minimum runway at least into mid-2024. This should give genedrive the time to demonstrate market acceptance and traction for the MT-RNR1 ID Kit (Antibiotic Induced Hearing Loss or AIHL test; recently recommended by NICE) and the CYP2C19 stroke genotyping test (to be launched in Sept/Oct with NICE recommendation anticipated in Q4 2023). We are leaving forecasts and target price under review until we have greater visibility over orders and hospital NICU utilisation rates.

Bankruptstock, selling and buying back cheaper sounds like a no brainer. Unfortunately, I have tried this before and ended up with fewer shares. It does need a good dose of luck. LTHs might have their own ideas about how lucky they’ve been so far with this stock!

If my past experience is anything to go by, I will sit tight until news flow of orders etc.

@System. More than Mr Budd! This is the only share I hold and have been holding since 2020. I had an average well over a pound. Fortunately, I decreased my average over the past year and this week I am even!

I am now considering averaging up in April with my ISA allowance, or waiting for any placing to pile in one more time.

I thinks there may be some confusion judging by some of the comments re. signing off and approval etc. The test is fully approved for use in the NHS, there is no doubt about that. Trusts are currently allowed to buy it.

What we’re waiting for is NICE to says it is ‘best practice’. This would enable trusts to obtain funding from NHS England to buy the tests rather than neonatal departments currently having to make a health economic case to purchase it. GDR were assisting neonatal departments make the case to trusts but this is an uphill battle in the current economic climate.

‘Best practice’ status would compel trusts to buy it if the test cost less than £20,000 per quality adjusted life year. Our test obviously qualifies - it’s a one-off cost of about £80 (?) and the benefit is for life.

Best Practice would really be a game changer for us. What I am slightly uncertain about is the legal force of the Early Value Assessment; will it still be required to be implemented within 3 months? If not, we’d have to wait for the full guidance in September.

By the way, the recommendation end March may well be conditional; but there’s no need to panic. It may well include the condition that on-going monitoring is required to ensure that the test doesn’t jeopardise the 1-hour window for administering the antibiotic. (This has already been demonstrated successfully in the PALOH trial. But they’d need to see it in mass practice).

My own neonatal department has stated that once it’s best practice they will adopt it as a matter of priority.

Patience is the key here.

It's interesting that we have a new partner in Greece. Wasn't there a pilot AIHL study in Greece last year? Perhaps the results of that are coming through; perhaps sales to soon follow?

Manxiety, was Cambridge University Hospitals one of the two interested trusts?

Hi Sledgey121, that’s a very reasonable question. The reason the alternative isn’t routinely given is that a) they are very expensive b) they don’t have quite as wide therapeutic effectiveness as the older ones, and c) there is a policy reason that scientists globally don’t want these newer antibiotics to be overused because there is fear if strains become resistant to the newer ones we’ll create superbugs resistant to everything.