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Finally a reminder of where the test kit stands:

30/05/22

Point-of-Care Genedrive(R) COV19-ID Kit receives Coronavirus Test Device Approval ("CTDA")

genedrive plc (AIM: GDR), the near patient molecular diagnostics company, announces that the UK Medicines and Healthcare Products Regulatory Agency has granted a CTDA enabling the sale of the Genedrive(R) COV19-ID Kit in the United Kingdom. Genedrive's application for approval, under the requirements that came into force on 28 July 2021 via The Medical Devices (Coronavirus Test Device Approvals Regulations (2021)), was made on 21 December 2021.

Since submission for approval, the product has undergone positive external validation, commercial partners have been engaged in specific countries, and product claims have been expanded to include the testing of asymptomatic patients.

David Budd, CEO of genedrive plc, said: "We are very pleased to have received a CTDA, which now allows the UK access to the fastest point-of-care COVID molecular test. The performance of the test has met CTDA standards in all regards, which positions genedrive well to engage in opportunities as they develop going forwards in the UK."

The Genedrive(R) COV19-ID Kit is a rapid molecular diagnostic test that delivers positive results as quickly as 7.5 minutes and negative results at 17 minutes. It utilises Reverse-Transcription Loop Mediated Isothermal Amplification (RT-LAMP) and a proprietary buffer formulation to achieve rapid results without requirement for user viral extraction steps. Performed directly from a mid-turbinate nasal swab, the assay targets the ORF1ab and N genes of the SARS-CoV-2 genome, adding robustness against emerging SARS-CoV-2 variants.

Some details from the article:

"And in another sign the authorities are taking the heavily mutated strain, Pirola, known scientifically as BA.2.86, more seriously, health officials today also confirmed Covid testing and community surveillance would be 'scaled up' ahead of this winter."

"Some pharmacies in London are reported to have completely run out of lateral flow tests as demand surged and are unsure when stocks will be replenished."

"Experts warned that Covid surveillance and sequencing remains limited, while officials urged Brits today to continue testing for the virus if they begin displaying symptoms."

"Health officials are spooked by Covid strain, Pirola, that is quickly spreading globally due to its catalogue of mutations. "

https://www.dailymail.co.uk/health/article-12464831/Pharmacies-run-Covid-tests-experts-urge-Brits-test-Pirola-symptoms.html

Could Genedrive's ill fated covid test have a new lease of life? Today's headline in the Mail Online:

"Fears Pirola Covid variant will 'overwhelm NHS' sees 'concerned' health bosses bring back community testing and pull forward booster rollout - as some stores run out of tests again."

System, best wishes for your operation and I sincerely hope it goes better than your predictions!

With the share price in steady decline for the last several months there is, understandably, a lot of pessimism about. So I thought it might be worth highlighting the positive side.

According to DB, GDR is the first company in the world to provide molecular diagnostics in emergency care. That has to count for something.

I have been assured that the next 12 months should see good commercial adoption of the company products.

The company is also working to expand its footprint outside of the UK, so not just reliant on the NHS.

Whilst most of the comments on this board have focused on full NICE approval, what the company is hoping to achieve is National Commissioning which is an internal process of the NHS. Commissioning is the process of assessing needs, planning and prioritising, purchasing and monitoring health services, to get the best health outcomes. Apparently GDR has a lot of advocates within the NHS!

Finally there is the stroke test product, the launch of which is expected by December. That could be a game changer.

So will all this change the company's fortunes? Time will tell but I remain hopeful.

Gloria: " the sp is below the level to take further drawdowns". This is not quite accurate. The answer I had from the company previously: "If the Company meets the requirements under MAC (Material Adverse Change) it can call for a drawdown. If it doesn't then the Company has to ask for the drawdown and this is done by mutual consent rather than formula." From that I read that further drawdowns can be negotiated whatever the share price.

Just to reiterate what JH has said, I have it from DB himself that sales ARE taking place!

Whilst most have been focusing on NICE guidance announcement for the stroke test, there is also another announcement we can look out for later this year: UKCA approval. This is most likely to come before the NICE guidance.

From DB: "“The Company remains focused on achieving release and UKCA approval of the Genedrive CYP2C19 ID Kit in advance of the final NICE guidance publication date. Our product has a number of performance and workflow features including ready-to-go room temperature reagents, rapid turnaround time, extended genomic variant coverage and integration capability with hospital data management systems that will foster its adoption and uptake compared to alternatives.”

A good article in the Pharma Times from May of this year:

https://www.pharmatimes.com/news/nice_green_light_for_genedrives_cyp2c19_candidate_1491793

I've noticed one or two unfamiliar names on this thread in recent days who show some familiar signs of classic pumpers and dumpers.

Multiple posts over a short period, all positive for the company.

Use of hyperbole designed to lure in the naive: "easy money", "wouldn't want to be out of it",

Predictions based on...pure speculation: "expecting an RNS within the next 2 months", "what ever your position, the future looks bright."

Deriding anyone with opposing views

Making out they're for the long term with statements such as "I'm staying for the ride north" when, make no mistake, they'll be out at the first opportunity to make a decent profit from the next spike.

Whether this is for the long term time will tell. I remember one occasion when I actually got to speak to DB. He expressed amazement that apparently there are shareholders still holding from 2013 when the sp was around 600p. With the sp having lost around 98% of its value since then, that doesn't exactly make for sensible investing!

I love the irony Gloria!

Systemzero, Will you stop trying to mislead everyone. If you look at the pricing and the balance of buys and sells it was almost certainly a sell. You seriously come across as a teenager who has nothing better to do all day than post nonsense on this board.

If that late million trade is RF offloading it's final share holding as I said might happen in view of the preponderance of buys to sells yesterday, then hopefully that will relieve the relentless downward pressure on the sp that we have seen over the past few weeks.

With buys outweighing the sells by more than a million this would be a good opportunity for RF to finish offloading, if they haven't done so already. without damaging the SP.

Hopefully this is a re-rate and not just a spike. The bits I like:

"...has now been extended to North Manchester General Hospital (NMGH) and Wythenshawe Hospital, part of Saint Mary’s Managed Clinical Service at MFT in July 2023."

"....has so far prevented the hearing loss of six babies in Greater Manchester since the pilot in 2021 through to the implementation of the test in 2022."

"...it is important that we do not delay antibiotic treatment. The new swab test technique replaces a test that traditionally took several days and is the first use of a rapid point of care genetic test in acute neonatal care. "

"While MFT is the first trust to routinely use the test, other NHS trusts in Greater Manchester will soon follow. Bolton NHS Foundation Trust​, Northern Care Alliance NHS Foundation Trust, Tameside and Glossop Integrated Care NHS Foundation Trust​ and Wrightington, Wigan and Leigh Teaching Hospitals NHS Foundation Trust are also set to introduce the revolutionary test in 2023."

johnlay****, "when did the company tell you that fda news was due by end july? they didn't." what i was told by the company back in mid may was that there was one more "iteration" with the fda and the company would then have to decide whether it was worth going ahead. this decision, i was told, would probably be in july. there would only be an announcement if there was a positive decision. so, by the absence of news i would assume there has not been a positive decision or that things have been delayed which would not be a surprise for this company!

I note some comments on D B's previous pronouncements and with the share price sub 14p I thought it worthwhile to see what he has said in recent RNS's:

1) Access to the Acute Medicine Unit in real time has considerable value to genedrive as further funding would allow us to progress ongoing product development quickly and efficiently. 16/06/23

2)Genedrive's CYP2C19 ID Kit is one of three exemplar projects to be included in the (Devote) programme...the total amount of funding to be made available under the programme will be determined in due course. 16/06/23

3) The Company remains focused on achieving release and UKCA approval of the Genedrive CYP2C19 ID Kit in advance of the final NICE guidance publication date. The Company is anticipating UKCA marking of the Genedrive CYP2C19 test prior to NICE's final report, currently scheduled for October. 19/05/23

4) The Company has made significant progress in establishing its commercial channels, engaging end-users and growing the awareness of our Genedrive MT-RNR1 test in particular.... our next 7 hospitals are expected to be up and running or implementing in the next few months....All of this combined with our participation in a separate NICE Diagnostics Assessment Programme for CYP2C19 makes for very exciting times ahead for the Company and our stakeholders. 31/03/23

5)This recommendation is expected to act as a catalyst for wider NHS adoption and, further, with NICE's reputation it is expected that the endorsement will also be beneficial to the assays commercial prospects as we seek to penetrate international territories. We are seeing the commercial traction resulting from our focus on pharmacogenetic testing and investment in the development of new products and are optimistic about our ability to succeed in the future, by creating value for our shareholders and by improving people's lives. 31/03/23

6) The Company is in ongoing dialogue still with the FDA to ascertain the requirements, and consequently the funding estimate that would be required to conduct and manage the evidence generation and submission process. 31/03/23

7)The Board is confident that the Company will see an acceleration of revenues through 2023 and going forwards...We are seeing the commercial traction resulting from our focus on pharmacogenetic testing and investment in the development of new products and are optimistic about our ability to succeed in the future, by creating value for our shareholders and by improving people's lives. 31/03/23

My Conclusions

1)D B has a history of making optimistic pronouncements and of using buzzwords and phrases which do not necessarily come to much. Examples from above: "remains focused", "is anticipating", "in due course", "exciting times ahead", "anticipating", "acceleration of revenues", "commercial traction", "creating value for our shareholders".

2)Time lines in particular are often far off course.

3)Finally, there is much that COULD happen. Only time will tell.

Systemzero. Say it often enough and you might one day be right. Even the broken clock is right twice a day! How about sticking to facts for a change!

It looks like RF have dumped at least 300,000 shares so far today in three 100,000 tranches...their trademark selling. So much for the theory that they can't sell if the sp is under 16p!

Re the debate on drawdowns, just to repeat the response I had from the Company spokesperson some weeks ago:

" If the Company meets the requirements under MAC (Material Adverse Change) it can call for a drawdown. If it doesn't then the Company has to ask for the drawdown and this is done by mutual consent rather than formula."

Make of that what you will!

Just after I posted I received a message from GDR on Linkedin:

"Were pleased to announce yet another successful audit of our Quality System and ISO re-certification for the Company. Its a very positive benchmark of effective product development and design processes, customer engagement, robust manufacturing capability, and overall company Quality culture."

So there's the first bit of positive news!