Gordon Stein, CFO of CleanTech Lithium, explains why CTL acquired the 23 Laguna Verde licenses. Watch the video here.
Lets be honest and REAL here. One cannot start comparing Cheek with Budd and saying things like "He has made David Budd look like a productive CEO"
Has it gone to plan as laid out by Cheek - NO! as far as we can tell. But Cheek came into an operation/setup that was not positioned in any way to commercialise it's products - the commercialisation game plan was not even drawn up by the former!
Https://www.youtube.com/watch?v=a_8Hsw0LwGQ&t=815s
Hemo from 15:40
@starresnstoff: the NICE review at this stag was not going to give full recommendation just yet, due to the clinical data set still being worked on which also ties into the process of attaining UKCA marking (registration required for clinical use). Once the UKCA marking is attained this data set can then be used by NICE to give a final recommendation for recommending GDRs POC CYP2C19 test kit to the NHS.
More importantly, the NICE review clearly recommended to the NHS, that CYP2C19 testing be used before any drug administration in (IS) stroke cases. Of all the tests analysed, (both lab and POCs), GDRs was the most cost-effective.
Hey @bapuk, did you get any feedback from genedrive regarding your below post??
.......
I recently came to know about this Accelerated Access Collaborative (AAC) method by which new drugs/diagnostics etc can get quicker route to NHS use/funding through this mechanism, rather than the Early Value Assessment pilot scheme which currently is how GDR have pursued this : Iām not sure if theyāve already explored this other option so Iāll email the company about it :
https://www.england.nhs.uk/aac/
@bapuk - may be worth just bringing your level of expertise and knowledge on the use of Clopidogrel outside of Stroke settings to Walbrook/Genedrive and see what they have to say about the current plans for the use/marketing of the assay outside stroke medical settings. Sounds like it can surely increase the importance on the POC assay and further increase the market for its use (win/win)!
Tender Noticeby SECRETARY OF STATE FOR HEALTH AND SOCIAL CARE ACTING AS PART OF THE CROWN THROUGH UK HEALTH SECURITY AGENCYTesting Solutions Dynamic Purchasing Systemhttps://bidstats.uk/tenders/2022/W24/776667357
Further to your points Cando66/Inphobe:
AIHL
This test was funded and developed in conjunction with the NHS via UK National Institute for Health Research (under the Department of Health & Social Care) and in accordance with NHS utilised NICE guidelines.
--------20 June 2018: Grant to develop and implement a point-of-care test in the NHS to avoid antibiotic-related hearing loss in newborn children (https://www.lse.co.uk/rns/GDR/grant-for-nhs-point-of-care-test-z0v7gogk4s8vxur.html)
---------07 Oct 2019: First ever research ethics approval for a neonatal point of care genetic test - Opportunity for widespread NHS adoption of test for prevention of hearing loss in newborns (https://www.lse.co.uk/rns/GDR/nhs-ethics-approval-for-use-of-aihl-test-in-trials-orc3b1no527jtcf.html)
---------03 December 2020: Antibiotic Induced Hearing Loss assay hospital trial completion (https://www.lse.co.uk/rns/GDR/aihl-hospital-study-completion-its9qqblhuu9kwt.html)
---------31 August 2021: New GenedriveĀ® system readied for Antibiotic Induced Hearing Loss launch (https://www.lse.co.uk/rns/GDR/new-genedrive-system-readied-for-aihl-launch-r7lea91aoani1es.html)
As per Nov 2021 presentation (available via https://www.investormeetcompany.com/) David Budd confirmed:
1) EU clinical study site established and running in Greece
2) The results from the UK NHS trial conducted have been accepted by a top/influential US paediatric scientific peer review journal. This is a very important achievement for genedrive in driving direct awareness and interest from paediatric professionals in North America.
3) Once funding is avail via UK and EU sales, US approval will be assessed.
Sales Estimates
UK - 100k tests per year
EU and US - 500k tests per year, each jurisdiction (approximately GBP 25m-35m).
Which implies the tests cost about GBP50 each.
This is in reference to CDC's own developed PCR test (DC 2019-Novel Coronavirus (2019-nCoV) Real-Time RT-PCR Diagnostic Panel) ONLY.
PCR tests is still a valid Nucleic Acid Amplification Test (NAAT) for Covid19.
Ok folks, so the most pressing items on the table are: (lets get some dialogue going add any factual info please)
1) CE-mark of GenedriveĀ® COV19-ID Kit POC
- awaiting official launch
- [RNS 10 Sep] - ".... targeting CE marking in October 2021"
2) GenedriveĀ® MT-RNR1 assay (AIHL)
- awaiting first sales from UK after new table-top GenedriveĀ® MT-RNR1 ID Kit CE-marked in Sep 21.
- [RNS 29 Sep] - "expecting its first sales in autumn 2021"
3)
Dave - as I have said, they have not once addressed overheads, instead ask for more money to commercialise products.
Well, if I was 100% committed to my business and its success I would either forgo some salary, reduce overheads and also consider salary to shares options.
I have also seen we have a Chief Commercial Officer - So we have so many ppl focused on commercialisation, together with partners and external distributors!!!
Sally, regarding POC I personally think this has a very good purpose within the testing mix. Both in terms of direct testing for specific sectors and operations but also for quick confirmation of any +ve LFTs.
I do think they are now afraid to make a stance on its real value given the outcome of the lab assay test.
Do I think we should be talking about US for POC. Absolutely not as the FDA give no attention to non-US org unless you have a US partner or US registered subsidiary.
@Winni - I agree, the CEO and Chairman have to take responsibility for the position the company finds itself.
Show genuine interest and desire to make this company a leader in commercialised products rather than proof of concept.
Grow a pair and come speak to investors - and PIs that is. Time to face the music and convince us!!
1) Profit (Loss) = Revenue - Expenses
2) Insanity is doing the same thing over and over and expecting different results.
If anyone can explain to me how DB and the board have acted to address cash burn and create a more sustainable business model, I'm happy to listen.
But keeping a cashburn rate of 400k per month and none related to stock manufacture is absurd now.
I need to see/hear commitment from the BoD and/or a revamped BoD.