Gordon Stein, CFO of CleanTech Lithium, explains why CTL acquired the 23 Laguna Verde licenses. Watch the video here.
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Tom, that's a loooong message and you've spent a lot of time composing it. I'm afraid I don't have the time to give it the reply it ACTUALLY deserves. However, my twopeneth ....
re "They should have the data immediately for release." The data doesn't "belong" to the FDA. It's commercially sensitive data submitted by the the pharma / med device company. If the FDA were to release to the public then IMO the FDA would be sued probably for billions of $.
In my understanding the FDA does not carry out any independent testing. The FDA reviews the data submitted and makes a decision accordingly. I don't know what the pass / fail criteria are and I don't know if / why 91% pass rate is acceptable.
All I will say is that 100% is EXCEPTIONAL and I doubt whether you'd find that in 99% of submissions.
Wolfiebill,
The point I was making was that these tests have been expedited by the FDA in a very short timescale. I was merely asking what the
conformance with positive test cases were.
They should have the data immediately for release. If they do not then before countries spend vast quantities of money on tests which may not have the desired 100% result, then they need to provide the info ASAP.
Otherwise, the cornerstone of test, test, test breaks apart and chaos ensues.
CDC initially released their own in house test that was not 100% conformance with positive test cases. This put the US on the back foot and probably led to the need for FDA EUA.
Tests should have been independently tested/peer reviewed.
The fact that NCYT makes the bold claim of 100% conformance is irrelevant to the point I was making. The bigger picture is that all FDA EUA tests should show 100% conformance with positive test cases.
The fact that the Roche test has been shown to gave 91% conformance with positive test cases proves my point. This result is surely unacceptable. The FDA now have to confirm this for thenselves in the case of Roche and others.
I was particularly interested in Thermo Fisher as I found no data on conformance towith positive test cases. This is the Company that the UK is going to fund to provide tests for nhs. Its important that these tests are 100%. Hence, someone of authority need to provide the evidence. FDA is best placed to do this. They know what limitations may have been applied in the process of granting FDA EUAs.
I note that NCYT make the bold claim:
The Company continues its extensive surveillance program to monitor strain evolution of the SARS-CoV-2 virus and the latest update continues to demonstrate a 100% homology of its COVID-19 test. To date, this means comparing the Company’s COVID-19 test to genome sequences from 1,700 known variations of COVID-19. The Directors believe this extensive surveillance and performance homology will continue to allow clinicians to use the test with confidence.
Hopefully all the other Companies granted FDA EUAs can make a similar claim to 100% conformance with positive test cases when their test comes under scrutiny. If not, their FDA EUA needs to be withdrawn.
It has been shown that the PrimerDesign does indeed provide 100% conformance to positive test cases in the same measurement study report that identified the Roche test had 91% conformance to positive test cases.
Whitty was indeed correct the 'one thing worse than no test is a bad test". No one can disagree with this.
Hope this clsrifies the point I was making.
Kettle - you're a black pot and filtered.
Fda and integrity in the same sentence.lol
Tom, re "What independent checks have the FDA done on these America First tests?"
I'm not what experience you have in the med devices industry, but let me tell you that the FDA is probably the most highly respected body in that industry and I'm sure in spite whatever the Great Donald might think / say I believe this organisation has integrity.
Test, test, test. We have only scratched the surface of how much testing needs to be done compared to how much has been done to date. They haven't even got to all health staff or key workers never mind those with symptoms or the general public at large. Looks like have the best kit around. Surely the SP can only go one way. I would guess £5 within a month or so.
The Roche test has 91% conformance to positive test cases. This does not look good.
For 1 missed case with R0 assumed as 3
Then growth per day is 1,3(2days),9(3days),27(4days)....
1 person infects 1M in less than a month.
Roche test FDA EUA assessment past in 24 hours.
Thermo Fisher FDA EUA assessment in 8 hours. What independent checks have the FDA done on these America First tests?
91% conformance for positive test cases is problematic with test, test, test .
NCYT is the leader. Todays RNS advises 100% compatibility from 1,700 known variations of COVID-19. Thats some golden goose to quote VanV we have here. My thinks this review by FDA can therefore only really benefit NCYT and highlight shortcomings in other FDA EUA tests.
I think the T/O price for NCYT has just gone up.
Research Thermo Fisher conformance to positive test cases....
gla.
Interestingly I emailed the FDA to ask for conformance of the Thermo Fisher PCR test to positive test cases.
Accuracy is the key not speed.
The UK's Primerdesign/NCYT (PCR) test provides 'unmatched [diagnostic] tool' which has '100% homology' with Covid-19 and is the most accurate available. That's a bold claim by this Company.
PrimerDesign/NCYT FDA approval application was lodged well before the announcement of adoption of FDA EUA's. Why is this important?
Because, with the implementation of FDA EUA's the stringent checks for independent conformance to positive test cases of the various manufacturers has probably been bypassed. Countries are using FDA EUA as a proxy for quality.
This is bad news for test, test, test. Why? Because false positive cases will be undetected and the spread continues.
Professor Whitty warned that the 'one thing worse than no test is a bad test". No one can disagree with this.
Hence with all the UK money being directed to the Thermo Fisher PCR test product, what conformance to positive test cases is their product?
To avoid unnecessary deaths, worth asking the question???
AMERICA FIRST would cause lots of issues for the covid 19 UK response.
In addition to Wolf’s post it’s worth reading the whole release...... it explains that labs were sure of EUA so didn’t use available tests! This has now been changed. One would assume NCYT will be used more now........
https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-expedites-review-diagnostic-tests-combat-covid-19