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The unravelling of Popeye2

I thought it would be useful to take a look at Popeye2's previous posts to understand his rationale.

"There's a lot of rampers on here that are in for a rude awakening." 20/07/24

"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

But we need to go back to last November for the possible motivation.

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

Sp then around 8p. So forced to sell at a loss and now another disgruntled ex shareholder??

Popeye: "There's a lot of rampers on here that are in for a rude awakening." The recent response I had from NICE re stroke test doesn't sound to me like we're in for a rude awakening.

"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."

A lengthy article in Investor.com. The key points:

1)Genedrive has been at the forefront of delivering rapid and accurate testing solutions, a critical need in today's healthcare landscape.

2)Throughout 2024, Genedrive has made remarkable strides in expanding its product portfolio and market presence.

3)Genedrive® MT-RNR1 ID Kit, ... has been pivotal in preventing antibiotic-induced hearing loss in newborns,

4)Genedrive's innovative product pipeline and strategic initiatives position the company well for long-term growth, despite short-term headwinds.

5)Genedrive has been proactive in its strategic initiatives to ensure sustainable growth.

6)The company has focused on expanding its geographical footprint, particularly in emerging markets where the demand for rapid diagnostics is high.

7)A key highlight of 2024 has been Genedrive's collaboration with global healthcare institutions.

8)Genedrive is well-positioned to capitalize on the growing demand for point-of-care diagnostics. Their focus on innovation and strategic partnerships will be key drivers of future growth.

9)The company's innovative products, strategic partnerships, and commitment to expanding its market reach are promising indicators of future success.

10)Genedrive is poised to make significant contributions to the healthcare industry, potentially driving substantial value for its stakeholders.

https://uk.investing.com/analysis/genedrive-plc-a-2024-analysis-and-future-outlook-200611794

For the avoidance of doubt, I repeat what I have learnt from the company re the stroke test:

1)They are confident that FULL recommendation will be given on the 31st July (or later if it is delayed again).

2)They are not concerned about lab testing as that is very time consuming, whereas GDR's stroke test is very quick.

3)Commercialisation of the stroke test in the UK has already started. The company is in discussions with trusts, stroke centres and health Innovation groups. Most will wait until the recommendation is published at the end of July but the company is looking at first sales coming in from September onwards.

Bearded Dragon, If you care to listen to the last IMC (Investor Meet Company) on YouTube that will provide you with all the evidence you need.

As I posted previously, following my feedback from the company:

Commercialisation of the stroke test in the UK has already started. The company is in discussions with trusts, stroke centres and health Innovation groups. Most will wait until the recommendation is published at the end of July but the company is looking at first sales coming in from September onwards. The company regards FULL recommendation as a given.

Yes!! We just had a £6million fund raise!

I've said it before...the company certainly regard full recommendation as a given.

Systemzero:

"Not expecting price to rise today" 18/07/24

"Retrace today" 17/07/24 Price up 11%

"Retrace today" 16/07/24 Price up 8%

"No movement in price , as we had the rise last week" 15/07/24 Price up 19%

It looks like the avatar is appropriate. The system really is zero!

Hi Big Al, Apologies for the mix up. The reference to lab testing does indeed apply to the stroke test, not to AIHL.

A lot of new names posting here. Good to see the the revival of the share price and the huge interest (transactions and posts here). Anyway, I've had some recent updates from the company, some of which I have already individually posted but I thought it would be good to gather them together here.

AIHL

Sales in the UK. Ongoing. Lab testing has been mentioned as a preferred alternative but this is not regarded as a problem as it's very time consuming compared to GDR's point of contact test.

Sales in Europe and the Middle East. 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.

FDA regulatory approval. The process can take anywhere between 18 months to 2 years. With the support they have, the company is aiming at the lower end of 18 months.

Stroke Test

Commercialisation of the stroke test in the UK. Commercialisation has already started. The company is in discussions with trusts, stroke centres and health Innovation groups already. Most will wait until the recommendation is published at the end of July but the company is looking at first sales coming in from September onwards.

Commercialisation of the stroke test in the EU. The company needs to obtain CE-IVDR and this is scheduled for completion by the 2nd quarter of 2025, so sales should be due from roughly September 2025 onwards.

Regulatory approval In the USA. Two possible routes. The 510k route could be quick and give the company access to the USA market within 6 to 9 months but the company would only be able to operate in the same way as Genomadix. Or the Denovo route which takes 18 months to 2 years but would allow the company to compete with the full range of the CYP2c19 test. Once all the information is gathered from the references in the USA the company will make a decision.

Commercialisation in the USA. The company can sell as soon as it gets the approval. They already have a partner in place that could order and undertake around 100,000 tests per annum.

Funding

The company does not anticipate for further fund raises before it reaches break even.

So the future for the company is IMHO looking very hopeful. A lot of positive news flow to come in the coming months!

" they're still saying lab testing is the most preferred option for this." In my recent discussion with the company, they don't regard this as a problem Lab testing is very time consuming, the GDR test very quick!

For newcomers, the response I received from NICE:

""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."

Bonzo, I contacted NICE and the response was 31st July at the earliest.

On a quiet day we might get a handful of posts but today getting on for 200 thus far. But lots of ramping going on. With posts such as:

"Should double today at the very least."

"this is the best RNS GDR have ever had."

"Today’s RNS is transformational"

"I think America will take this to 50% Up today"

Make no mistake, this is good news on top of anticipated good news (NICE full recommendation at the end of the month). However there is a way to go yet. Substantial sales for a start. But hopefully now the sp will continue it passage north albeit there will be some bumps along the way.

Now I see one of the reasons why the company was so optimistic when they told me that they did not anticipate the need for a further fund raise until they reached break even in 2026 (see my previous post).

Hi Muminir, That would be nice but in their previous guidance they specified by mid 2026.

Hi BigAl, "My hope is that they believe we can pay for this extra cost through Increasing Product Sales ?!!" I've talked to the company and that is indeed their belief...that they will not need to come back to the market for more funds before they become self sufficient in 2026. Optimistic? Time will tell.

SPQStrader, NICE was via email, but not my contact with the company which was verbal. All will be revealed on the 31st...unless there is a further delay. Remember 31st July is the earliest publication date. And btw the company doesn't know more than us investors. They are frustrated by the lack of communication from NICE. Remember they learnt of the delay from the NICE website, not via any communication from NICE. In spite of that they seem very confident.

SPQTrader, I posted it previously but I'll post it again. The response I had from NICE when I enquired about 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."

I have also confirmed with the company that they regard full recommendation as a given.