Member Info for JimiHendrix

I think this is the Spanish partner David mentioned in the presentation that they had recently signed up. He made it clear that it is not the same distributor they had for the covid poc test.

No quote to buy anything at the moment.

Something related to the 2 distribution partners is my best guess, or possibly FDA related.

I had 8p as a technical bottom, and we’re also expecting news of the two new European distribution partners imminently. David said there were 2 partners they were expecting to sign up very soon, as they were in the very final stages of some thorough due diligence which they are carrying out with all suitable partners to basically make sure the partners know what they’re doing and will be able to actually sell the product, they have learned from past experience that they can’t just take on any distributor and expect them to make sells.

We might well have European sells before the NHS.

Also worth remembering that AIHL will save the trusts money every year.

Yes they’ve said that before in last years presentation (or the one before) and they decided to go with a placing.

So many trades getting hidden and then popping up later. Maybe mm’s trying to hide the volume…

Sounds like they're more focused on a strategy of innovation and research rather than commercialisation. Anyway, AIHL looks good though the lack of budget in the NHS is concerning... there doesn't seem to have been any further uptake since the initial Manchester rollout.

Cash today will be £2.6m, enough to last until June 2023 however a fundraise will be needed well before that, my guess is a big fundraise around February/March.

Less in the bank than I was expecting…

“Our unaudited cash balance as at the end of October 2022 was £3m, reflecting a monthly burn rate of £0.4m since the year end.“

So today they have about £2.7m in the bank.

and now it's down -16.36% according to Bloomberg.

I’m expecting an enormous contract win or buy-out offer from a large US diagnostics company over the weekend to be included in Mondays RNS, as why else would they release it after the weekend. Lol… #positivevibes

They need to release a Notice of Results RNS first before actual results, it’s very late this year.

Thought we would have had notice of results by now, reckon we will in the next 7 days

It’s been a while since I checked in on Powerhouse, originally bought here almost 10 years ago now! Good to see things seem to be progressing.

Is it possible the company may need to do a placing?

The 510(k) and the De Novo processes are similar in that they are both pathways to market for medical devices with low to moderate risk, which is Class I and Class II. The biggest difference between the two is that the 510(k) heavily relies on the concept of "substantial equivalence" to an existing medical device.

…well there isn’t a substantially equivalent medical device is there? Lol, one of the big selling points is that this is a novel test with no competition.
…

The De Novo request provides a marketing pathway to classify novel medical devices for which general controls alone, or general and special controls, provide reasonable assurance of safety and effectiveness for the intended use, but for which there is no legally marketed predicate device.

I think that’s only if the FDA confirm that the 510k route is suitable for our test I think. It’s not clear at all, because the more I’ve read about it the more it sounds like we can’t go the 510k for the reason being the FDA hasn’t approved a similar or equivalent test in the market.

To clarify, from a recent RNS…

Genedrive's new CYP2C19 Kit is targeted for completion in Q1 2023 and will require approval under the new IVDR regulations.

SO as per that article in my previous post we can deduce the approval will take around 6 months after completion (for it to possibly be available August).

It sounds as though the Stroke test might not be available until next August at the earliest, having read this article from today.

I thought launch was supposed to be Q1.

https://t.co/40OVIy14Qq

Costs depend if they’re able to go 510 (k) route or the other one. 510 k can be very low cost if testing and approval has already been carried out in another country (see link I posted).

The big question is whether they can go 510 route or not as that’s a much quicker and cheaper way into the market. I’ve read various conflicting things online this afternoon, so I’m not sure and I guess neither is the company.

Reading the RNS again, doesn’t these 2 paragraphs suggest that 510k will not be possible because there is no equivalent comparable test?

“ genedrive has submitted via the FDA's Pre-Submission process ("Pre-Sub") because there is no exact comparable test in the market already….

“ A 510(k) is a premarketing submission made to the FDA to demonstrate that the device to be marketed is safe and effective, that is, substantially equivalent, to a legally marketed device that is not subject to premarket approval (PMA). The De Novo pathway provides a vehicle for establishing new predicates that can reflect modern standards for performance and safety and can serve as a basis for future clearances. De Novo classification is a risk-based classification process used when there is a lack of predicate device already cleared by the FDA.”