Member Info for Eureka01

I thought it would be a good idea to present both the positives and negatives for investing in Genedrive.

Stroke Test: Positives

1) NICE: "Evidence from studies provided by the company suggests that the Genedrive CYP2C19 ID Kit works well. It can detect more CYP2C19 alleles than the Genomadix Cube point-of-care test. It also does not need a freezer to store reagents is cheaper per test than laboratory tests and the Genomadix Cube"

"There are likely to be considerable barriers to implementing laboratory-based testing for everyone who has had an ischaemic stroke or a TIA."

2)Sales in the UK: Initial order for the CYP2C19-ID Kit and instruments from Greater Manchester's Comprehensive Stroke Centre. From my talks with the company, I understand that they have been in discussions with trusts, stroke centres and health Innovation groups. Most were waiting until the recommendation was published at the end of July but now the company anticipates further sales coming in from September onwards.

3)EU Market: Receipt of CE-IVD certification in addition to UKCA certification would enable the company to penetrate markets which it estimates are worth in excess of £100 million per annum.

4)USA Market: I understand that the company is getting good feedback on both the speed, accuracy and closeness to the patient for the test.

Negatives:

1)NICE: "Despite Genedrive having the highest net benefit of the 3 tests assessed in modelling, the committee concluded that laboratory-based testing was its preferred method."

2)Sales in the USA: CYP2C19 testing has been in place in the USA for around 7 years so there are already many established suppliers for the company to compete with.

AIHL: Positives

1)Sales in the UK: ongoing.

2)Sales in Europe and the Middle East.: I understand that the company is 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 the company is looking at further progress coming in September onwards.

3)Sales in the USA: The company already has a partner in place that could order and undertake around 100,000 tests per annum once the test is approved.

Anticipated News Flow: Positives:

1)Further sales of the AIHL test in the UK

2)Further sales of the stroke test in the UK.

3)Sales of the AIHL test in Europe.

4)FDA start of registration for stroke test later this year.

5)NICE full guidance for AIHL: process starts in October.

6)AIHL specialist commissioning for AIHL: due April 2025.

7)CE-IVD certification for stroke test: anticipated early 2025.

8)Subsequent sales in EU for stroke test.

9)FDA registration of stroke test.

Negative:

Some of the news flow (6-9) is some way ahead and dates can change.

There we have it. I leave it for others to decide whether the company is a good investment or not. I remain a holder.

No advice intended. AIMHO DYOR

Not for the first time Stu is forgetting what he said the day before: "No point me posting further until next RNS."

I'm curious as to why he keeps posting here when he has said he doesn't hold.

The lies and distortions of Slacker. A few examples from today:

"The stroke marker test is NOT time critical!!" Not true. Someone posted this earlier: "DAPT with aspirin plus clopidogrel should be initiated early (ideally within 12–24 hours of symptom onset and at least within 7 days of onset) and continued for 21–90 days.".

"THE NICE RECOMMENDATION IS LAB TESTING....there's nothing to discuss!!" There's plenty to discuss!

"When will lab testing not be available??????????????" I previously gave the example of S E London where one laboratory was hacked in June and has caused severe disruption to testing with even some operations having to be cancelled.

"Absolutely nothing to keep this from falling back to 1.5p" Plenty of potential news to come and don't forget AIHL!!

"Uou might want yo look at level 2 Carnage!" Yet, at that time the sp bounced up, so not carnage.

He really sounds desperate.

Stu, "NICE have ... recommended LAB testing as the national preference". What you conveniently continue to overlook are the following:

1)Laboratory testing is over stretched.

2)POC offers a much quicker diagnosis.

3) GDR's POC test HAS been approved for use in the NHS. Contrast this with the Alzheimer’s drug Leqembi which, though passed by Britain's drug regulator, has NOT been approved by NICE for use within the NHS.

4)Finally this from NICE themselves: "The guidance does not override the individual responsibility of healthcare professionals to make decisions appropriate to the circumstances of the individual patient, in consultation with the patient and/or guardian or carer." So the clinician can decide to use the POC test if he/she feels it is in the best interests of the patient.

I suppose that's why the sp has just bounced up.

269 posts over the last month of negativity. Slacker clearly has serious issues.

"The NICE accreditation is an extremely stringent process". Agreed. Look what's happened to the Alzheimer’s drug Leqembi. Britain’s drug regulator has authorized saying it's the first medicine to show some impact in slowing the progression of the neurodegenerative disease but NICE has separately issued draft guidance concluding that the benefits of Leqembi “cannot be considered good value for the taxpayer. So, for the moment, it's not available on the NHS.

ON August 6th the sp bottomed out at mid price of 2.65p. It then went on to peak at 3.825p (mid) just two days later. Today the sp bottomed out at 2.675p (mid). Will this prove to be another inflection point for GDR, hopefully more sustained this time? And of course some positive news would help. For the record, I topped up today.🙂

Ok Stu, your responses leave me particularly unconvinced. So two simple questions for you:

1) Why are you posting when you promised you would not post again?

2) Why do take such an interest in a share that you say you do not hold?

Stu, As one who says he is not a holder you seem very interested in this share. Two points you have raised in your posts today:

1) "The recent NICE RNS was bad news not good!"

In that case how come the chairman, who is no fool, bought a million shares AFTER the NICE news?

2) "To suggest clinicians will not follow the NICE recommendations is insulting their professionalism"

So how come NICE in their guidance say: "The guidance does not override the individual responsibility of healthcare professionals to make decisions appropriate to the circumstances of the individual patient, in consultation with the patient and/or guardian or carer."??

Slacker, ",there are 125 hospitals that offer laboratory tests!" Where do you get that information from? If there were so much laboratory capacity as you and certain others maintain then why does a cyber attack on one laboratory have such an impact to the extent of forcing some operations to be postponed and to have a continuing effect more than 2 months later ??

June 17: "Owing to a cyber-attack affecting an NHS pathology service provider known as Synnovis, all non-urgent primary care blood tests have been paused until further notice across south east London. This affects all blood tests that happen in community and primary care clinics, requested on a non-urgent basis by primary care/GPs....Unfortunately, some operations and procedures which rely more heavily on pathology services have been postponed, and blood testing is being prioritised for the most urgent cases, meaning patients have had phlebotomy appointments cancelled."

Latest message just received from my surgery: "Unfortunately the restrictions on the number of tests being taken is still ongoing but it is hoped that improvements will start to happen in the near future."

Stu, A few weeks ago you posted this:

"My last post, why ?

It’s becoming more apparent to me that some genuine LTH’s are suffering both financially but more importantly mentally. Unfortunately my posts appear to antagonize which is not my intention.

So I’ve made clear my opinions and shared independent third party papers to substantiate.

I will not be responding further with the exception of ;

1. I’m proven wrong.

I would then return only to publicly admit my error.

2. Upon future RNS with subsequent request by any forum member for my comment."

Neither apply as of now, yet you are still posting.

On another note, my surgery is experiencing delays in blood tests:

"Phlebotomy (blood tests) services are still restricted until further notice. This is due to the ongoing impact of the cyber attack on Synnovis, the provider of pathology (test analysis) in south east London."

Another reason for having more POC testing or at least the option of having POC tests available when needed?

"The trade was mine. I sold out.".

That's slightly at variance with your post from a week ago: "in two months the share price will be much different. A lot of patience is required"

Yes, it looks like it. 21 posts today following on from 30 plus posts yesterday. But for the last hour and a half not a word. He said he had more than 400,000 shares. A large sale, 450,000, went through this afternoon. He works hard for his trades!😁

Gloria " totally agree with a few here who have been asking for more PR". When I spoke to them last month they only had one salesman for the UK and one for the rest of the world. Maybe they could invest in another salesperson.🙂

Stu, "NICE is the organization who ultimately call the shots on what is or is not used by the NHS.

It is not a group of local clinicians to decide on national recommendation."

Two key points in the NICE recommendation:

!)"There are likely to be considerable barriers to implementing laboratory-based testing for everyone who has had an ischaemic stroke or a TIA. If laboratory-based testing is not available, or it will take a long time to develop capacity to provide it, then point-of-care tests could be used. So, the Genedrive CYP2C19 ID Kit should be used when laboratory-based testing is not available."

2)"The guidance does not override the individual responsibility of healthcare professionals to make decisions appropriate to the circumstances of the individual patient, in consultation with the patient and/or guardian or carer."

So if the clinician considers speed of results to be the priority he would use the POC test whatever the guidance.

Stu,

1)Of course they would want the POC test to continue to be monitored. It is a new product. The product would already have undergone lengthy testing over many years for NICE to have given it FULL recommendation.

2)At the moment we don't have the lab capacity and IMO it would take years to build that up.

3)Most importantly, there is often a need for speedy results which the POC test gives and labs do not. So even when they have built a National Lab testing capacity there will still be a need for the POC tests!

So just focus on two words, SPEED and AVAILABILITY. But I guess you can lead a horse to water though you can't force a horse to drink. 🙂

Stu, " the most important aspect of nice following scotlands lead to develop national lab testing over poc, when having considered poc cost and time savings is undoubtedly the elephant in the room !!"

You miss the point. NICE prefer lab testing but sometimes there is the necessity of speed. To quote Professor Bill Newman: "To ensure that patients receive the correct treatment to reduce the risk of them having a further stroke after an initial episode, we need to use a rapid genetic test. The development of this new point-of-care diagnostic has the potential to significantly improve care for tens of thousands of patients after a stroke."

Then there is the question of availability. From the NICE final recommendation: "Use the Genedrive CYP2C19 ID Kit point-of-care test for CYP2C19 genotype testing when laboratory-based testing is not available"

"There are likely to be considerable barriers to implementing laboratory-based testing for everyone who has had an ischaemic stroke or a TIA. If laboratory-based testing is not available, or it will take a long time to develop capacity to provide it, then point-of-care tests could be used. So, the Genedrive CYP2C19 ID Kit should be used when laboratory-based testing is not available."

And NICE make it clear that the guidelines do not overrule the judgement of the clinician. "The guidance does not override the individual responsibility of healthcare professionals to make decisions appropriate to the circumstances of the individual patient, in consultation with the patient and/or guardian or carer."

You're also forgetting GDR has the AIHL test of which you make no mention.

I've posted them before but as Popeye is continuing his deramping crusade, I'll post them again.

From today: "The company is still well overvalued. Market Cap should be closer to £10M." "Genedrive is just one huge disappointment..."

Here is a selection of some of Popeye's previous posts:

"I very much doubt they will raise the necessary minimum £6M." 14/05/24

" I really can't see how they're going raise cash via a placing." 26/03/24

" A raise at this stage would not be available to GDR."13/03/24

"I think that the next RNS will be to announce that the company has filed for administration. 13/03/24

His motivation? His post from last November gives the game away.

"I've started to build a sizeable position" 14/11/23

Sp was then around 8p. So I suspect he was forced to sell at a loss and has now become another disgruntled ex shareholder.