Member Info for Eureka01

Ok, it's worth reminding newcomers some of the events we can look forward to in the coming months.

Additional sites in the UK for AIHL....any time

Commercial progress for AIHL in Europe and the Middle East....any time

Completion of DEVOTE study (stroke test)....this month

Full recommendation for stroke test by NICE....31st July

FDA, start of submission process for AIHL....late 2024, subject to funding

CE IVD submission for the stroke test....2nd half 2024

Certification for stroke test....early 2025

Specialist commissioning for AIHL....April 2025

Mraverage trader: "Is there any other key milestones in the next few months to be aware of?" The DEVOTE study by the University of Manchester is due to complete the review process soon.

At this point NT to buy even in small quantities. MMs are clearly short of stock.

Drnash, "Eureka the tone of that email reply is very positive it almost seals in that the approval is granted and the delay is only because they want to publish associated guidance to help implementing this" Agreed. I'm not worried if there is a further short delay. The important thing is that full recommendation seems to be in the bag and that is the view of the company as well.

Hi Big Al. Point taken. I also spoke to the company recently. They are frustrated by the lack of direct communication from NICE (they had to learn of the delay through the NICE website). The good news is that they regard full recommendation of the test as a given.

Big Al, the email I had from the project manager at NICE in response to my questioning the delay:

"RE CYP2C19 genotype testing to guide clopidogrel use after ischaemic stroke or transient ischaemic attack

NICE is working in partnership with colleagues at NHS England and NHS Improvement, to develop a resource to support the implementation which will publish alongside the final guidance. To allow time for the implementation resource to be finalised, the earliest anticipated publication date for the final guidance will be 31 July 2024."

Hi Big Al, As it was my first enquiry to NICE re delays I am not in a position to answer that question. It could well be a standard response which doesn't always get followed up on but you would think they would keep the company at least informed of delays.🙂

I have received a similar response to an enquiry I had made to NICE following the previous email from another site that I highlighted and am thus able to confirm that that email was genuine. This response to me ended "We thank you for your patience on this guidance development and will notify you if we expect any further delays with publication." Which raises the question as to why the company had to rely on the NICE website to learn of the delay to the publication date when NICE is prepared to keep a casual enquirer informed of developments.

Yes, I've had a look at the volumes. Around 340 million shares were traded in the 13 trading days from the 6th to the 24th giving an average of 26 million per day. Around 170 million shares were traded from the 25th to the 28th giving an average of 42.5 million per day. So it's possible PH have now sold out but given the fairly restrained sp action of the last few days I'm not entirely convinced.

There has been some wild speculation about Peel Hunt's present holding. I'm not going to speculate but just point out their previous disposals and what that would mean if carried out at the same rate now.

On the 5th June PH held 20% of the company or 108 million shares. By the 24th June they held 10.5% of the company or 57 million shares. So in the course of 13 market days they had disposed of 51 million shares or an average of 3.9 million shares per day. At that rate of disposal they would take a further 14 market days to complete their disposals... so by around the 12th July. Of course there is nothing to say that the future rate of disposal would match the previous disposal rate. But IF the disposals were to have been completed by that time , it would make an interesting run up to the new publication date on the 31st given that previously the sp rose by 15% in spite of PH selling nearly 10% of the company in that earlier period.

PadRock, As a previous poster has indicated, it's on the advfn website, time stamped 11.19:

https://uk.advfn.com/stock-market/london/genedrive-GDR/share-chat

On another website I came across this email response purportedly from the project manager at the National Institute for Health and Care Excellence :

"RE CYP2C19 genotype testing to guide clopidogrel use after ischaemic stroke or transient ischaemic attack

Resolution has now concluded, so we plan to publish as soon as we can. NICE is working in partnership with colleagues at NHS England and NHS Improvement, to develop a resource to support the implementation which will publish alongside the final guidance. To allow time for the implementation resource to be finalised, the earliest anticipated publication date for the final guidance will be 31 July 2024."

So if genuine, the actual delay is NOT on account of the CYP2C19 ID Kit but so that NICE, in conjunction with NHS. can develop a resource to support the implementation which it will publish alongside the final guidance.

In that case the delay would turn out to be very positive.

I, for one, topped up today.

The most recent document from the advisory committee wanted comments from registered stakeholders, healthcare professionals and the public on the following:

Has all of the relevant evidence been taken into account?

Are the summaries of clinical and cost effectiveness reasonable interpretations of the evidence?

Are the recommendations sound, and a suitable basis for guidance to the NHS?

The closing date for submissions was 26th April. IMO those submissions have taken a little longer than anticipated to analyse (maybe the response was greater than anticipated?). I certainly don't regard the short delay as negative.

The RNS came out, followed by a few panicky sells and then the buyers moved back in and the sp edged up again. All fairly predictable.

Hmmm, System zero, I don't normally resort to personal insults. With your almost daily predictions which 99% of the time never materialize, I hardly think you're the sharpest tool in the box. "if all was going well there would be no delay" As others have pointed out it could actually be a positive sign. They could just be making sure that everything is ok and it's taking a bit longer than anticipated.

what a load of *******s gets spouted here. comments like "what this means to me is we are/were not getting full recommendation", "of course gdr fully aware of this during the last raise", "cheek and his crew new it was nearly over for gdr then i believe", "i expect this to fall below placing price" are all wild speculation. people need to chill out a bit. yes, it's a delay of 3 weeks, not the end of full approval!

As I pointed out yesterday, the fact that the market had been able to absorb 10% of the company being sold by PH and still manage a rise of 15% over the previous 3 weeks is very positive and IMO bodes well for the outlook for the sp at least in the run up to July 10.

Just to clarify, 10% of the company!

The positive I take from this is that in spite of PH having disposed of 10% of its shareholding since the 5th, the share price has actually gone up. Closing mid price on the 5th 1.475p. Mid price now 1.675p., and increase of 15%

Interesting. Last week Peel had 102 million shares, Then at 11.11am 79 million, at 11.12am 61 million and finally at 11.13am 57 million. So disposed of 22 million shares in the space of 2 minutes! Another RNS coming up for the buyer?