Member Info for Eureka01

Time to look at the upside and downside of GDR at present.

Positives

AIHL

1)The company now has a research partner, a leading multi state physician group within the USA "to support clinical studies required for engagement with the FDA to progress the regulatory approval of the Genedrive MT-RNR1 ID Kit into the USA." In the interims we were told that this organization has "broad coverage of neonatal intensive care units nationally". So ideally placed.

2)GDR also has a distributor agreement with International Biomedical Ltd "to support the FDA study and future sales in the United States ". So a 2 pronged approach to progress to approval in the US.

3)Can be used in the NHS with the NICE conditional recommendation.

4)New sites already announced in the IMC presentation.

5)Potential £100m market in the UK.

6)Specialist Commissioning being pushed for.

Stroke Test

1)Public consultation which started in May 2023 finally ended today after multiple delays. Publication date is scheduled for the 10th July....though NICE approval could come earlier James Cheek in the IMC presentation: "Cannot see any reason why anything will change to the final recommendation".

2)UKCA certified which permits sales within the UK.

3)DEVOTE study anticipated completing in May with submission shortly thereafter.

Negatives

AIHL

1)The de novo submission to the FDA is anticipated to start in late 2024, subject to funding, according to the CEO in the IMC presentation.. So some way off and the caveat of "subject to funding". But the new partnership should help!

2)Specialist Commissioning might not be before April 2025 though earlier approval is being pushed for.

Stroke Test

1)The review process following the DEVOTE study is anticipated to take 5 to 7 months, so some way off.

Finances

Positive

1)No Riverfort overhang at present.

Negative

1)Urgent need to raise funds.

So there we have it. Lots of potentially positive news flow but the elephant in the room is the urgent need to raise funds.

Genedrive plc, a leader in point-of-care pharmacogenetic testing, has partnered with a major U.S. physician group to conduct clinical trials for FDA approval of its Genedrive MT-RNR1 ID Kit. This revolutionary test aims to prevent antibiotic-induced hearing loss in newborns, which has significant health and economic benefits. The test is particularly relevant for the U.S. market due to its birth rates, litigation costs from antibiotic side effects, and favorable diagnostic testing environment.

https://www.tipranks.com/news/company-announcements/genedrive-advances-fda-approval-for-hearing-loss-test

I see MAJWandCo. is at it again. He seems very determined to push the price down. He forgets that the need for a fund raise was clear long before the IMC last Friday and the interims last month. He also forgets that counter balancing the need for funds is the potential for positive news in the coming weeks and months.

Ok, price already up 5.8% today. Let's see how it pans out.

MAJWandCo, You're assuming the price remains at 6p. IF it goes up then that could still be a good buy. Otherwise no one would buy if a placing was in the offing.

Some seem disappointed by today's presentation. But I was reasonably happy with it. First I did not expect anything dramatic. As I pointed out earlier we would have had an RNS if there was something dramatic to report.

Secondly there were many positives, albeit some of them a repetition of known facts.

1)Tests are low cost, rapid (as little as 26 minutes), touch screen operated, no need to send to labs, no need for fridges or freezers.

2) CYP2C19 has the UKCA, permitting UK commercialisation.

3) AIHL, Total addressable UK market £100 million.

4)AIHL, Waiting for US strategic partner to sign.

5) CYP2C19, They can't see any reason why anything should change between draft and final submission in July.

6) CYP2C19 could be used outside the realms of strokes, for anybody being given clopidogrel, to test whether the patient will have problems metabolising it or not. So potential market for the test could be much higher than currently forecast as JH pointed out.

7) AIHL, Two new UK sites coming on this week.

8)They believe Riverfort has no more shares to offload.

9) They still have £1.5 million on Riverfort funding. They would like to offer the investors a chance to participate. Not wanting to draw down further at present. So hopefully Riverfort not off loading millions more shares on the market, depressing the share price but it is there in case!

So all in all I'm reasonably satisfied today.

Logic would dictate that any fund raise would be on the back of a positive piece of news so that the price of a placing/ open offer (if they go down that route) would be maximized. IMO

"Still got £1.5 million on Riverfort funding. Would like to offer our investors a chance to participate. Not wanting to draw down further at present."

Q "Have there been discussions to take the company private?"

A "Not something I would want to discuss".

"We believe Riverfort have no more shares to offload!"

"AIHL, two new UK sites coming on this week"

"CYP2C19, can't see any reason why anything should change between draft and final submission in July".

"AIHL, Total addressable UK market £100 million".

"CYP2C19, UKCA, permitting UK commercialisation"

Https://www.investormeetcompany.com/investor/dashboard

"Tests are low cost, rapid (as little as 26 minutes), touch screen operated, no need to send to labs, no need for fridges or freezers."

I see the rampers such as David6576 are out in force today, Wild assertions such as going to 50p in a few weeks or 100% today are likely to be well short of the mark. I expect the IMC to be positive but tempered by the need to fund raise. So let's not get carried away. If there was an important announcement we would have seen an RNS.

Familiar pattern emerging today. MMs raise their prices to get sales and after the short termers have taken the bait more buyers pile in and the MMS raise their prices again.

Slacker, do you have to shout? That smacks of desperation.

:=)

"Could this be the equity placing that was talked about?"

Definitely not.

From the Half Year Results:

""The Board intends to provide a mechanism for retail shareholders to participate in any equity financing and a further announcement will be made in due course."