Member Info for JimiHendrix

Right that's good, so we can assume the FDA submission via De Novo for AIHL MT-RNR1 is still on track as per their RNS regarding achieving breakthrough device status.

Roger, yes I'm quite sure about the differences. The 510(k) pathway is around 90 days and the De Novo pathway anything from months to over a year.

This is potentially excellent news. If as you report, that they are debating which route to take then it means they’re considering the 510k route instead of the De Novo route. De Novo requires clinical trials where as 510k doesn’t and is much faster. So presumably are thinking that the data gathered in the UK may be sufficient to satisfy the FDA. If so we’re looking at 90 days for the approval process.

Important to remember that testing (lab or POC) is more cost effective than not testing at all. It’s literally impossible to use lab testing any time soon nationally for the stroke marker gene, it would take years to build the facilities able to handle the numbers. Genedrive POC will be used, I have no doubt.

It hasn’t, what it’s recommended is the following which is looking pretty good for Genedrive considering that lab testing is not feasible at such a scale…

“NICE has proposed a way forward to help limit the strain on services while testing capacity is increased over time. A phased rollout is suggested, with tests offered to those at higher risk of stroke recurrence, or point-of-care testing within the community “as an alternative if laboratory-based testing is not feasible at this scale, or while capacity for laboratory-based testing is increased”.

I think the Genedrive stroke marker POC test will be used nationally for minor strokes, which is a far larger market than non-minor strokes ...lab testing is being proposed for the smaller non-minor strokes market as there simply isn't capacity to cover all strokes.

Roger... Brighton has adopted the test routinely and is not in Manchester. I've also spoken to somebody quite recently who confirmed rollout is happening in parts of Surrey, Sussex and Kent.

Intraday it reached 2.7p... which is undoubtedly close to 3p ...lol

Stroke marker test sales orders expected this month, fully cashed up, exciting times!

It also elaborates with the following…

“however, the chance of a bullish confirmation that will change the signal to BUY is quite high.”

“This is a three-candlestick pattern signaling a major bottom reversal.”

It'll be confirmed as a buy signal today, it's usually better to increase a position before the confirmation though to get the best price rather than wait for the herd ...imo.

BB also says "...but the chance of a bullish confirmation that will change the signal to BUY is quite high." "...This is a three-candlestick pattern signaling a major bottom reversal."

That was Manchester so expected, first sales outside Manchester are expected this month.

The company is expecting sale orders for the stroke marker test to begin this month. Now is not the time to be selling imo.

I’m not so sure because after a major stroke, clopidogrel is started later (I don’t know why).

“Anticoagulants should be started within 48 hours after a minor or moderate stroke, or 6-7 days after a major stroke - this will be advised by a stroke physician.”

Upcoming sales will not stop directors from being able to buy shares, we've been told the market can expect more sales for both tests will come as NHS adoption continues. Knowing that sales are coming does not constitute inside information, it's already out there.

There may be more director buys to come.

Emerald, they're starting a pilot study for the stroke marker test now...

"Further testing will be carried out at Greater Manchester’s Hyper Acute Stroke Unit (HASU) at Salford Royal Hospital, part of Northern Care Alliance NHS Foundation Trust, to establish the benefit for patients across Greater Manchester. HASU is the largest dedicated unit in the region and provides care for people across Greater Manchester. This work is part supported by the Geoffrey Jefferson Brain Research Centre through the Edward and Victoria Bonham Carter fund and NHS England Network of Excellence in Pharmacogenetics and Medicines Optimisation.

This pilot is an important step in understanding the set-up costs, workforce and other requirements to roll out this innovation wider.

Dr John McDermott, Clinical Geneticist at MFT and NIHR Fellow from The University of Manchester said: “Genomic medicine is changing the future of healthcare and we are delighted NICE has recommended the use of the test in the NHS."

https://www.manchester.ac.uk/about/news/manchester-leads-implementation-of-lifesaving-genetic-bedside-stroke-test/

Just to clarify, I’m referring to the stroke marker test. It’s possible the POC pilot about to begin in Manchester has nothing to do with the national pilot referred to in nice guidance - the national one might be a lab testing pilot.

As always, transparency is lacking!

I’d like to know how long the trial in Manchester is going to take and whether the NHS are holding back on further adoption until completed. This will give us a clear idea how long until further sales. Some pilots are as long as 12 months, so I’m hoping this is not the case.

* “This will be followed by testing at Greater Manchester’s Hyper Acute Stroke Unit (HASU) at Salford Royal Hospital, part of Northern Care Alliance NHS Foundation Trust, to establish the benefit for patients across Greater Manchester”