Member Info for Eureka01

johnlay****, i note the irony of your post. i would ask, please don't shoot the messenger! as i said i have the emails to prove my dialogue with the company and their spokesperson. i cannot speak for the communication, or lack thereof, that others have. i can only speak on what my interaction has been with the company and its representatives. if people prefer me not to pass on what i learn, then so be it.

Thanks for your kind words,Roger65. Lionel, I already have it twice now from the company spokesperson. Once from the 17th July and the confirmation yesterday and I have the emails to prove it. I'm not going to push it too far. Yes, I had noted and pointed out the apparent contradiction but I think the relevant word is "intends". Clearly, for whatever reason, they are having second thoughts. Funnily enough when I did get to speak to James before he left, that was the one question he asked ME, what my thoughts were on the matter. I suspect there is a lot of debate on the subject within the board.

Further to a previous poster's assertion that the company had chosen the De Novo pathway for the MT-RNR1 ID Kit. and that it had already begun back in July, I have now had confirmation from a company spokesperson that, as I thought, the company is still undecided. "The matter is still undecided for now, and they will make a decision based on what they think is best once they have all the information."

The sp is not yet back up to where it opened two trading days ago. So let's not get carried away!

"It was confirmed in the RNS that Genedrive would pursue De Novo pathway". The RNS says this: "genedrive intends to pursue the FDA De Novo regulatory pathway for entry into the U.S. market." The use of "intends" indicates that it's not quite done and dusted. But the interesting part is that that announcement came out on the 15th July. I received my response on the 17th. So not quite sure what to make of it.

Cheer up Roger, I wouldn't write the company off just yet. I recall when Popeye posted this back in March: ""I think that the next RNS will be to announce that the company has filed for administration." Well it didn't happen.

When I spoke to the previous CEO he seemed confident that even another raise would not be needed...ie that the company would become self sufficient.🙂

Back in July I put the question re timelines to the company and had this response re the two possible routes they could go down with the FDA:

"This depends on what we do. We are currently in discussion with a number of CYP2C19 testing centres in the USA and Key Opinion Leaders to consider if we go with a reduced solution via a 510k submission using Genomadix as a comparator or if we go via the Denovo route with all of our testing capability.

The 510k route could be quick and give us access to the USA market with 6 to 9 months but we would only be able to operate in the same way as Genomadix or the Denovo route takes 18 months to 2 years but would allow us to compete with the full range of the CYP2c19 test. Once we have gathered all of the information from the references in the USA we will make a decision."

So the decision is presumably still pending as we have had no announcement on the issue.

I've had a quick look at the posts today. A lot of gloom out there. Some are panicky holders and some are the usual derampers. Some of the latter, I suspect, have been burnt and are venting their frustrations and others are trying to get the price down so they can get in cheaper.

Why is the price declining? It may be Peel Hunt still offloading. The last announcement was on the 24th June when they were under 10%. It could be stop losses being triggered on the way down. It may be those who got in at 1.5p taking profits. Probably a mixture of all three. But clearly the absence of news concerning sales, aside from the £100k purchase by Manchester's stroke centre must be weighing heavily. With the summer holidays I was not expecting much action but I shall be looking for sales news in the coming months. If we don't get substantive sales announcements both for the UK and abroad in the next quarter I would be worried. But for the moment let's have a bit of calm.

AIMHO

Stu. I'm afraid you are just obsessed. Not being told if something will happen is not is NOT the same as being told that something will not happen!!

Roger65 and one or two others don't seem to get it into their heads that other countries want to evaluate the test first before putting in larger orders. A similar procedure was followed over here. Once again I'll remind those posters what the company told me: "We are looking to get further sales in Europe and the Middle East from September onwards, a lot of the pilots are due to finish at the end of July but with most of Europe shutting down during August we are looking at further progress coming in September onwards."

So I'm not concerned that there haven't been further orders abroad thus far. If we don't get orders September to December then I would start to worry.🙂

I did get a couple of responses from a company spokesperson on two issues which nave been highlighted recently and have been of some concern.

1)POC stroke test v lab testing:

"NICE have issued their recommended guidance for the test which suggests it will be used as a priority." That may not be how some interpret the guidance but that at any rate is the company's interpretation.

2)Kelliop:

"Genedrive became aware of Kelliop a few months ago after some PR they released, but they don't have any additional information to add over and above what's in the public domain and has been picked up on already. There are no publications relating to their device/test and their website does not provide any details. If the company get any new information from their US collaborators, we will release this news accordingly." From the lack of publications, peer reviews and other accreditations I don't think we need to worry too much about that one for the moment at any rate.

AIMHO

Roger65: " Anyone selling below 10p will look back with major regrets in a year’s time imv" 19/08/24

Ten days is clearly a long time in share dealing. 😁

Much is being made of this Kelliop device on this board. But let's look at the facts.

1)Kelliop is a company with one employee founded by a Chinese lady, Amanda Binbin, who previously worked in China.

2)The FDA granted novel breakthrough device designation to GDR, not to Kelliop. The designation is given to NOVEL medical devices that have the potential to provide more effective treatment or diagnosis.

3)The GDR device is much further along the road regarding testing and accreditations.

4)"Kelliop plans to seek FDA approval later this year". I read that as starting the process for seeking approval, similar to what GDR is planning, not obtaining the approval itself.

5)The Valley Children Hospital article is old news...from the 25th June.

6)The chairman bought a million GDR shares on the 15th August. Hardly likely to have purchased if if he had fears about a foreign competitor.

Alright, I said it would be my last word to you on the subject but since it's so blatant I will respond. You have taken the word "significant" from another post of mine which clearly says it does NOT imply significant sales. I can only assume that you have some sort of mental blockage or are being deliberately perverse. So for total clarity I have NOT been advised of significant new sales. So, please, now leave us all in peace!

Stu, You really are flogging a dead horse and this will be my last response to you on the subject. Nowhere in my post have I used the word "significant". I used the word "further" several times which could indicate any number. As you admit yourself, you are paraphrasing yet you avoid quoting my exact words . If you twist my words to suit your agenda then that is your problem. As you don't believe in the company or its products I suggest you quietly move on to a company you can believe in.

Just further to my last post I checked back and the exact words used were "We are looking to get further sales in Europe and the Middle East from September onwards" and "we are looking at first sales coming in from September onwards". Both of those phrases to me indicate an expectation.

Oh dear, Stu ferreting here again in spite of assuring us on more than one occasion that he would not be posting again and that he was not a holder. He has yet to state why, in that case, he takes such a keen interest in this share.

In relation to sales I have not used the word "significant", I have used the word "further". What company would not be expecting /hoping for "further" sales?? I would hardly regard that as price sensitive. It is an expectation which is a hope or an anticipation, not a firm proclamation. And, yes, Stu, maybe you could also give it a rest whatever your agenda is.

As I mentioned already. a number of pilot trials on AIHL have been taking place in Europe which were due to finish in July. So the hope is that these pilot trials will lead to commercial orders in September after the summer shutdown.

For the stroke test, CE-IVD certification is the necessary accreditation for EU sales and there is a huge potential market out there.

Hi Stocksaint, Don't worry, I was not given any price sensitive info but I did have feedback from the company last month as I had previously mentioned on this board. So, to clarify, "looking to get" does neither imply "significant sales" which you refer to nor, from my understanding, is it a given. It is a company expectation which hopefully will materialize!

Gloria, Thanks for your comment and have a great weekend too. Thanks also Big AL for your feedback on CYP2C19 testing in the US . The comment re established suppliers in the US was feedback I'd had from the company themselves but maybe they were referring to lab testing being well established in the US as well as to the more recent arrival of the Genomadix Cube. The GDR test, as you point out, is preferred by NIICE over the the Genomadix Cube. From their final guidance: "The committee also noted that several features of the Genedrive test could offer advantages over the Genomadix Cube . For example, its reagents do not need to be stored in a freezer and it can detect several additional alleles including those that occur in greater frequency in some ethnic groups. The committee also noted that the estimated cost per test for Genedrive is less than for Genomadix. So the committee concluded that Genedrive was its preferred point-of-care test." So, agreed, I'll take all that as a positive for the US!