Member Info for JimiHendrix

The FDA must review the 510(k) and "clear" your device before you can legally sell or distribute it in the United States.

The FDA timeframe for 510(k) review is calendar 90 days (60 days before they respond with main decisions).

The 510 (k) route sidesteps all the waiting from the typical FDA process. There is some controversy around it in the US, but the upside for us is we may well be looking at revised income figures for next year. With this news today and fast tracking the NICE process we can reasonably expect decent orders Q1.

Potentially £35 million + from both the UK and US markets, in which we have no competitors. The market will respond soon enough, I can actually see a reasonable chance that the share price will be over £1 again in the next 6 months.

The news today is huge in my view!

Potential income to Genedrive from the US market is £30m per year I meant lol (from my recollection, I’ll read back through the RNSs later).

I’m still researching 510 (k) but my initial understanding is that we may be able to begin selling (not only marketing) with 510 approval.

If so that is massive news, the US market is £30-40m I think?!

I was thinking we were in September for some reason lol.

Anyway we should hear substantive review decisions within 60 days… so December.

*late December not November!

However we should hear something after 60 days…

Generally, 510(k) applicants can expect submission acceptance review decisions within 15 calendar days; substantive review decisions within 60 days; and final decisions within 90 days.

Sorry yes 90 days, 2 weeks to hear that it was accepted for review. So approval probably around the end of November.

Very exciting news! So in 2 weeks time we can start marketing AIHL in the US. Things will really kick off then, with no other competition, it’s going to get a lot of publicity over there which will fuel even more interest worldwide and back in the NHS… likely speeding up rollout over here like a snowball effect. We know there is growing interest here already, 510 (k) clearance the US in 2 weeks should turbo boost that.

This is regarding IHC’s interims today…

“ Also, Inspiration has changed the way it manages its distributed infusion therapy business to target areas that had previously been more marginal, such as pain management and chemotherapy. Management also notes growing interest in the neonatal community for Genedrive’s point-of-care test to screen infants in an urgent care setting for a genetic variant that causes life-long hearing loss. The product has been launched in both the UK and Ireland where Inspiration is the distributor for the product.”

I think it’s inevitable that we will do well with AIHL. It sounds as though marketing efforts are beginning to pay off.

Hopefully some orders for the POC COV will transpire too as a nice bonus as Winter approaches, and the the Stroke test launching in the new year.

Over the weekend I read an article about the new covid variants and how many organisations have started bulk ordering covid tests again in preparation for a possible surge in cases. We know lamp tests are still being used in certain circumstances in the NHS, so there must be markets out there for it and ours is still the best lamp test at there.

One thing to bare in mind is that companies don’t always announce orders (even large ones) until they release results. If you read IHC’s results they’ve mentioned 2 new large orders previously unannounced… 1st mention of two rather larger orders (each around £1.3m) to Iraq & Egypt respectively.

Covid infections have doubled in Bristol over the past week, hospital admissions and patients on ICU are increasing too. New variants are taking hold and immunity (and efforts to protect) are low.

Potentially the beginning of a new waive in the UK.

Before the end of the year usually.

It’s extremely encouraging to see AIHL being fast tracked through the NICE review process. The NHS clinics want to get onboard but need the NICE recommendation for decision makers.

NICE is well respected, credible and trusted by the public, clinicians and other stakeholders.

It wouldn’t surprise me if European clinics see the fast tracking as a green light to begin rolling it out too.

NICE’s Early Value Assessment for Medtech will help do just that. By offering a rapid assessment of digital products, devices and diagnostics for clinical effectiveness and value for money, the service and patients will be able to benefit sooner.

Early Value Assessment is being designed to draw in the most promising and impactful medical technologies where the evidence base is still emerging, starting with digital products, in areas where there is greatest need. Whether its empowering patients to better manage their own health and seek clinical advice, reducing admissions and waiting lists or supporting clinicians and other front-line staff to provide better quality care this new programme will help to alleviate system pressures as the NHS recovers from the COVID pandemic.

They won’t fail to sell AIHL, it’s being fast tracked for a good reason.

I don’t think there will be a placing now - this fast tracking has drastically speeded up the timescales for expected income from AIHL.

Fantastic news! I noticed the NICE dates had changed yesterday. Now we have both the AIHL NICE guidance and stroke test expected Q1.

I’m not sure there will be a fundraise now either. With all the publicity AIHL has been receiving recently and now the fast tracking, it’s clear there is significant demand and pressure coming for full NHS uptake. I’m now expecting sales and further rollout this Autumn.

Expecting the NICE provisional schedule to be published at some point tomorrow outlining the AIHL timeline.

It could easily rise 100% back to 25p over the next month if sentiment returns.

I had a good informative email reply from genedrive last week outlining the benefits of the Cov poc over seemingly accurate LFT tests. That, on top of reading the recent government article talking highlighting where molecular tests are still being used in the NHS has changed my view. I think there’s a strong chance of sales as there is clearly a market out there.

There’s also the stroke test launching in 3-6 months.

This was published last month…

https://www.gov.uk/guidance/covid-19-testing-during-periods-of-low-prevalence

There are definitely still circumstances where molecular tests are being used. They mention care homes and hospices amongst others situations too.