Ryan Mee, CEO of Fulcrum Metals, reviews FY23 and progress on the Gold Tailings Hub in Canada. Watch the video here.
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!
Good Evening All, I had a response to a few questions I put to the Company so I thought I would share.
1)Much interest surrounds the amount that will be allocated to the Company from DEVOTE. The company doesn't yet have an update on that amount but I am told it is "likely" that they will announce once they know. I would imagine that update is not too far off!
2)I imagine I'm not the only one confused by the terms of the deal with Riverfort. The response to my question regarding those terms did not do much to enlighten me! I asked whether once Riverfort have sold their existing allocation of shares they would then be able to buy shares at a much lower price, and therefore cause further dilution, to make up for the shortfall. The response was that the initial 2 million is covered by "consistent terms". As far as the further 300k drawdowns they subscribe, I was told, "as per the conditions of the deal that was announced". So not much further enlightenment on that one!
3)Finally I queried whether the deal was in the best interest of shareholders but was told that it should be in their best interest "because shareholders voted in favour of it"!
So there we have it. I continue to hold as I believe there should be a steady pipeline of positive news IMHO in the coming months.
Hopefully we'll be seeing headlines like this, one day, for the MT-RNR1-ID Kit (AIHL) and the CYP2C19 ID Kit (stroke test).
"FDA approves blood test for pre-eclampsia risk"
https://abcnews.go.com/WNT/video/fda-approves-blood-test-pre-eclampsia-risk-100635999
Prof Dame Sue Hill (@CSOSue), Chief Scientific Officer for England and Senior Responsible Officer for Genomics in the NHS, shares her thoughts on the future of genomics and what it will enable.
https://twitter.com/GenomicsEngland/status/1673968279084253189
Surely GDR has a role to play here.
Fromthe government website:
Digital NHS Health Check to be rolled out across England next spring delivering an additional one million checks in the first 4 years.
Tens of thousands of cases of hypertension expected to be identified and hundreds of strokes and heart attacks prevented
Each digital check could save 20 minutes of NHS time - potentially freeing up hundreds of thousands of primary care appointments
A digital NHS Health Check that will deliver one million checks is to be rolled out across England from next spring, the government has announced today (Thursday 29 June).
https://www.gov.uk/government/news/new-digital-health-check-to-tackle-deadly-cardiovascular-disease
The sayings of Nathan today:
"This is overvalued at this price and hence the daily SP decline."
"No news on sales...so down we go..!"
"Any dogs and cats can short this share. Easy money to be made here folks. See you all under 7p"
"I can see 50k worth of shorts just opened."
"Sell off now started."
"Looks like this is heading down to 10p"
"Time to jump off and save yourself sinking with the ship."
"Sell off started guys. time to get out before the traders sell off."
Looks like Nathan's had a busy morning.
Shame for him that the sp has gone up 8% while he has been share bashing.
Looks like no bonus for him today. :-)
JH you posted: " if the share price goes below 16p then the terms of the facility will have been broken and there will be no more monthly drawdowns (and no more warrants being issued)." I think you're wrong on that one.
1)As I previously mentioned, a Company spokesperson has confirmed to me that it isn't correct that GDR can't get further drawdowns if the sp falls below 16p. I was given a rather obscure answer that 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,
2)The sp has already fallen below 16p. On the 20th June 100,000 shares were sold, almost certainly by Riverfort, for 15.75p.
Cheers MyIPA! What worries me slightly is that clearly an FDA approved study would cost a sizeable sum whatever the numbers yet in its announcement on the 31st March re the Equity Prepayment Facility, the Company said: " ...The Company is not currently planning for a material increase in the Company's operating expenses in the future." But there are other options, including a partnership with a US company.
The sp is drifting down again. Sadly without news and with Riverfort sales in the background I feel that will be the pattern. Someone mentioned that the Riverfort selling has not made much difference to the sp but the fact is that if they had not been selling you would have expected the sp following the DEVOTE news to be much higher!
Once Riverfort complete their selling AND we get significant news that should IMO change. Drivers ahead will be the details of the DEVOTE funding if significant, additional distribution partners for AIHL, additional go live sites in the UK, promotion and launch of AIHL in EU countries, NICE recommendation for stroke test, launch of stroke test in the UK if recommended by NICE, FDA news if the outcome is positive and above all news of significant sales.
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Just to add to my previous post, on the 7th I posted: " On the Devote issue, I think (and this is my own speculation) that we would get an announcement once we were involved which I'm sure we will be."
I rest my case!
No, Stephen, I'm not Canadian! :-)
MyIPA, " I'm still not sure what to believe when you say have contact with the company judging by your very much bearish statement on the Devote just a few days before the RNS last Friday." I posted on the 6th. The announcement came on16th! So at the time I posted it was absolutely true that GDR was "NOT involved with the DEVOTE programme at this stage."
"And here we are again, no public evidence of discussions which really should be confidential. I mean, it sounds reasonable, but also not quite reasonable as well." So it really sounds as if you are in two minds on the whole subject!
Absolutely take your point about normal discussion. It's a shame some have to resort to insults to make their point!
The cost of the FDA approval is insignificant. What costs is the study itself. The company would need to demonstrate that the product is working in its intended setting. Apparently, unless the Company could persuade the FDA otherwise, there would be a need to screen 40,000 babies!! Clearly beyond the resources of GDR on its own!
Hi MyIPA. Wwhat I was told by the Company is that there is one more "iteration" in a series of dialogues with the FDA which started last November. The dialogues are on how the Company would put a study on the efficacy of the AIHL test together. After that last iteration the Company will then have to decide whether it's worth going ahead. This decision will probably come in July. I was told that there would only be an announcement if there was a positive outcome, which is contrary to speculation on these boards that an announcement is a given.
This great news today brings at least four things to the table:
1)Additional funds.
2)Less reliance on the Riverfort funding.
3)Recognition by those that matter that GDR's test really does have an important role in the neonatal setting.
4)Adds credibility when being considered by potential end users not just in the UK but abroad as well.
....Professor William Newman said: " We look forward to working with genedrive and our other DEVOTE programme colleagues in Manchester to develop a framework for time-critical pharmacogenetics, and to provide the framework for assessment of implementation of the Genedrive(R) CYP2C19 ID Kit in emergency care. DEVOTE will further establish the Manchester environ as a world recognised centre for the development and implementation of pharmacogenomic testing."
David Budd, Chief Executive Officer of genedrive plc, said: "DEVOTE is an amazing opportunity to engage formally with a health system like the NHS to demonstrate the effectiveness of a new diagnostic approach. 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, and would support the pathway to clinical validation of our Genedrive(R) CYP2C19 ID Kit. This level of clinical input and evaluation is increasingly required by regulatory authorities prior to marketing product especially in the EU. We are privileged to continue with our partners at UoM and MFT in developing time-critical genetic test solutions."
Multi-partner grant awarded for the validation of Genedrive(R) CYP2C19 ID Kit in time critical NHS settings
Manchester NHS Industry partnership programme for rapid genomic test implementation
genedrive plc (the "Company"), the point of care molecular diagnostics company, today announces its participation in a multi-partner grant award ("DEVOTE") from Innovate UK and the UK government Innovation Accelerator programme with funding expected to be made available to further the validation and implementation of the new Genedrive(R) CYP2C19 ID Kit pharmacogenetic test in a time critical clinical setting.
I think it's worth reminding what was said at the Investor Meet Company last November and how the Company has moved on since then.
AIHL
St Marys Hospital up and running.
Two more hospitals in the process.
Eight hospital clusters/groups in the sales funnel.
Distributors appointed for UK and Spain.
The Progress
Preliminary recommendation in the UK by NICE (Feb 2023).
NICE's final recommendation on following a public consultation period (30/3/23).
AIHL test in routine NHS use with a further 7 hospitals in the North West of England in the process of implementation (Interims 31/3/23)
New commercial distribution agreements for AIHL in place in Spain, France, Austria, Greece, Saudi Arabia, Kuwait and Turkey (Interims 31/3/23)
Stroke Test
Targeting UK launch date March/April 2023.
The Progress
Preliminary recommendation in the UK by NICE (19/5/23).
UK launch set back to September/October 2023
Expected News Flow in the Coming Months
Additional distribution partners for AIHL.
Additional go live sites in the UK.
Promotion and launch of AIHL in EU countries.
NICE recommendation for stroke test.
Launch of stroke test in the UK if recommended by NICE..
FDA news if positive outcome.