Roundtable Discussion; The Future of Mineral Sands. Watch the video here.
Excellent post from Stephen11 on Special Commissioning. Just to add a bit more meat to the bones, some pointers from the NHS website on Specialist Commissioning:
1)Specialised services support people with a range of rare and complex conditions.
2)These services include a range of treatments, from interventions that most of us have heard of, such as chemotherapy...through to pioneering procedures that are currently only carried out in small numbers.
3)We have a legal duty to fund certain new medicines and devices recommended by the National Institute for Health and Care Excellence (NICE), but we also make available additional funding each year for other new treatments.
4)For these new treatments, we have to make complex decisions about which represent the best value for patients and taxpayers. We have a duty to ensure that new treatments are supported by convincing evidence of safety and effectiveness, that they are affordable and offer value for money, and that decisions about them are fair and transparent.
5)All the proposed new treatments are independently assessed by the Clinical Priorities Advisory Group (CPAG) on their likely relative clinical benefit and relative cost.
IMHO, going by the above criteria, Genedrive's MT-RNR1 ID Kit would seem to be a no brainer for acceptance.
There was £3 million available for the draw downs, £300k over a 10 month period starting 30th May 2023. Drawdowns of 300k were made in June, July and November and now the latest of £600k so that leaves half the amount, £1.5million still available but with the time limit set at 30th March of this year.
Drawdowns are continuing, this one for 600k:
Equity Prepayment Facility drawdown
genedrive plc (AIM: GDR), the point of care pharmacogenetic testing company, today announces a further scheduled £600,000 draw down under the terms of the £5m Equity Prepayment Facility, which was previously announced by the Company on 31 March 2023. Investors have been granted 3,093,915 warrants equal to 40% of this drawdown divided by the Reference Price of 7.7572 pence. The exercise price of the warrants payable to the Company will be 140% of the Reference Price equating to 10.86 pence.
The focus there is December. The rest of the year is summarized in the Final Results:
-- Genedrive(R) MT-RNR1 ID Test receives positive final recommendation in NICE's Early Value Assessment programme
-- Genedrive(R) MT-RNR1 commenced rollout in Greater Manchester hospitals
-- Commercial distribution agreements for Antibiotic Induced Hearing Loss (AIHL) test in place covering Spain, France, Austria, Greece, Saudi Arabia, Kuwait, Turkey and the Netherlands
-- UKCA marking achieved for new Genedrive(R) CYP2C19 pharmacogenetic test
-- Benefiting from GBP1.2m multi-partner grant awarded for the validation of Genedrive(R) CYP2C19 ID Kit in time critical NHS settings. The Company is expected to receive cGBP0.2m directly
-- The draft NICE guidance recommends CYP2C19 genotyping for clopidogrel treatment and Genedrive(R) CYP2C19 ID test modelled to be a clinically and cost-effective option. Final NICE recommendations pending
-- Investor Placing Agreement of up to GBP5m secured with GBP2.3m drawn down during the year and a further GBP0.6m drawdown post year end
-- Pre-submission process ongoing with the Food and Drug Administration ("FDA") to determine regulatory process and requirements to place AIHL into the American market
Good Morning....from where I am. Just received a nice summary of the Company's achievements this year on Linkedin:
"We finished the year strongly at Genedrive this month!
Royal Sussex County Hospital, in Brighton, went LIVE, implementing the Genedrive® MT-RNR1 ID Kit in their neonatal unit for routine clinical use. The simple, non-invasive point of care pharmacogenetic test will be used to guide treatment prescription to avoid antibiotic induced hearing loss.
We supported our partners, EUROCARE SAS, in Paris at the Journées Francophones de Recherche en Neonatologie. Dr Peter Reynolds spoke on how bedside screening using a pharmacogenetic test can prevent aminoglycoside-induced hearing loss.
Our Greek partners, ANTISEL, exhibited at the 22nd Panhellenic Congress of the Hellenic Society of Perinatal Medicine (HSPM), where Dr. Stamatia Staikoudi presented about how rapid, point of care testing can guide treatment in time critical settings.
Finally, we received international orders for the Genedrive® MT-RNR1 ID Kit from France, Austria, Greece, Saudi Arabia, Turkey, and the Netherlands!
Thank you to the whole Genedrive team, our partners and #NHS for making this happen! Much more ahead of us, but we are looking forward to getting started in 2024.
That concludes our 2023 Year in Review. We at Genedrive wish you all a happy festive period and wonderful new year!"
Personally I am looking forward to a brighter future for the Company in 2024 and best wishes to all for Christmas and the New Year!
I did post back on May 15th after discussion with DB himself: "We have heard about distribution agreements but not about sales. The delay between getting a distribution agreement and getting sales is because most countries need to register a product which can take up to 6 months. Then there is the business development cycle where new funding for a product needs to be applied for. However I was assured that sales ARE HAPPENING in the background." And again on 14th August: "I have been assured that the next 12 months should see good commercial adoption of the company products."
So great to see that sales have now been confirmed in an RNS and the relevant countries named. The sp has soared over 20% on this news. This should, imho. be just the start of positive news flow ahead. Yes, there is the dampener of a cash call, in some form or other, early next year but longer term I am optimistic..
"....so we can deduce from that, that they are in fact now able to make drawdowns when needed." It's not quite that straightforward. I had it previously confirmed by the company that if the price is under 16p then further drawdowns are a matter of negotiation.
Over in the Far East at the moment and just catching up with things. Great to see the news from Monday of Brighton adopting the AIHL kit. Hopefully the first of many such announcements in the coming weeks and months!
For me the positive of Wednesday's trades was that, in spite of a 2 million share sale, the sp remained steady.
Strange how some, supposed holders, continue to tear the company apart. Slacker, for instance, posted nearly 50 posts yesterday (in my time) such as "For those that know this will be back to sub 8p by Friday PM", "DROPPING LIKE A STONE
You will get used to that.....trust me!!!!", "No money in the bank, No income. No approved products, Yeah great investment!!!!" Yet the curious thing is that he still seems to be trading the share! His post from the 29th Nov, for instance: "Bought in this morning, sold and took a small loss". Not a great trader it seems....if only he had waited a few days! I suspect he now wants to see the sp drop so he can buy in again and then sell at a small profit when the sp rises!
Once any RF overhang is cleared I believe, with the roll out of positive news to come, that we have a much brighter future. Yes, there is the need to raise additional finance but hopefully the good news to come will make that a lot easier and that there will be some substantive income coming in from sales. I was not happy with the RF deal and I did put it to DB at the time why he had not gone for a placing or open offer. His response was defensive, He had an experience in the past when an open offer had been attempted and the response had been zero!
But hopefully now, onwards and upwards!
AIMHO
Did everyone get the Investor Meets Company email?
The full text:
"GENEDRIVE PLC will be holding a Full Year Results Briefing meeting on 30th Nov 2023 at 10:00am GMT.
Please click on the button below to accept the meeting invitation.
Accept
Should you have any questions, please contact support@investormeetcompany.com.
Kind Regards,
The Team at Investor Meet Company"
Clicking on the link in the email will take you to the IMC website where there is another link to ask a question. So an opportunity to air all those investor concerns!
Just an update to my previous post. I've been told by a company spokesperson that the date of the Finals will be announced next week. The CEO will host an IMC (integrated marketing communications) so we'll have the opportunity to submit and ask questions at that time. We certainly need some pertinent answers with the sp languishing at multi year lows!
Some good news ahead? I put several questions to the new CEO through a company spokes person but the answer came back that due to the high level of "retail" in GDR he was not able to respond to individual shareholders. Retail: "the sale of goods and services to consumers." Loose use of language or are we at last getting some sales??
Secondly I was told that he is planning an IMC (integrated marketing communications), where shareholders would be able to put forward questions, in the coming weeks. So watch this space!
"£1.2m innovation award for Manchester diagnostics firm’s latest kit
Manchester molecular testing business, genedrive, expects to benefit from a £1.2m innovation award.
The Development and Validation of Technology for Time Critical Genomic Testing (DEVOTE) grant, from Innovate UK and the UK government Innovation Accelerator programme, will provide the company with acute care patient access and supporting infrastructure to assess the real world clinical performance of time-critical clinical tests in NHS settings.
Genedrive said it will benefit through the programme’s lead partner, the University of Manchester, that will support the evaluation, validation and implementation of its new Genedrive CYP2C19 ID Kit.
DEVOTE is funded through the Innovate grant, in-kind contributions, and other aligned funding, the vast majority of this funding will be paid directly to the University of Manchester to support the company’s initiatives.
James Cheek, genedrive chief executive, said: “The DEVOTE programme is an incredible opportunity for us to partner once again with the University of Manchester in developing time-critical genetic test solutions.
“The grant funding allows us to avoid costs that would otherwise have been incurred by genedrive directly and to benefit from accessing the Acute Medicine Unit, which is paramount to our product validation under IVDR.”
Mr Cheek assumed the CEO’s role earlier this month when former CEO, David Budd, announced his immediate departure.
Genedrive’s ward-based genetic test has received a product mark from the UKCA (UK Conformity Assessed), the UK’s equivalent of the European CE mark, after a process taking several years of development and validation.
The test can quickly tell healthcare professionals if stroke patients will benefit from the current first line treatment, to prevent recurrence.
Strokes affect more than 6,000 people in Greater Manchester each year. Individuals carrying changes in a gene called CYP2C19 are twice as likely to have further strokes when treated with the first line preventative treatment, clopidogrel.
Genedrive worked with a clinical team from The University of Manchester and Manchester University NHS Foundation Trust (MFT) on the device."
https://www.thebusinessdesk.com/northwest/news/2121656-1.2m-innovation-award-for-manchester-diagnostics-firms-latest-kit
Ok sadly the rise to 13,5p didn't last long but the news agencies seem to read the announcement as an award of £1.2 million to GDR.
"Genedrive shares rose after it said it has been awarded a U.K. government grant to validate and implement its CYP2C19 ID Kit--for guiding therapy selection in stroke patients--in pharmacogenetic tests.
Shares are up 1.5 pence, or 13% at 13.25 pence.
The molecular-diagnostics company said the 1.2 million pound ($1.5 million) grant, from Innovate UK and the UK government's Innovation Accelerator, will provide it with acute care patient access and supporting infrastructure, to assess the clinical performance of time-critical clinical tests in U.K. public health service settings.
"The grant funding allows us to avoid costs that would otherwise have been incurred by Genedrive directly and to benefit from accessing the Acute Medicine Unit, which is paramount to our product validation under [In Vitro Diagnostic Regulation]," Chief Executive James Cheek said
https://uk.advfn.com/stock-market/london/genedrive-GDR/share-news/Genedrive-Shares-Rise-on-GBP1-2-Million-Grant-to-V/92147607
Agreed stocksaint but the wording " in order to support the further drawdown and delivery of its GBP5M Equity Prepayment facility that was announced on 31 March 2023, application has been made for the Admission to trading on AIM of 3,100,000 new Ordinary Shares of 1.5p each ("New Ordinary Shares")." surely implies that there will be further drawdowns!
So much for the ones who said that drawdowns couldn't take place if the sp was below 16p.
My post from the 14th August in response to Gloria who had posted that the sp was 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."
In spite of the doom and gloom from some posters there have been some chunky buys over the last week or so. Someone accumulating?
15/09 100000 @11.2p (listed as a sell but almost certainly a buy)
14/09 200000 @ 12p
13/09 100000 @ 12.5p
13/09 100000 @12.9p
07/09 100000 @ 12.3p
What the likes of Slacker, Joe Bloggs and Stocksaint can't see is that though having the UKCA mark is not the final goal of full NICE approval, it is an important step along the way as well as generating interest in the product.