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@computer909, don't know enough to say for sure but it is worth noting that FIND is a not for profit organisation that is not aligned with any government and they specifically do not endorse or validate a product. The eu list requires at least one member state to have validated the test. The inclusion in the list of the FIND data for those that have it appears to me to be just supplementary information.
@TWatcher, Does the German FIND study not meet the validation requirements, i assume it does and Mologic will appear on the list when it is next updated.
TWatcher, before you pat yourself on the back, none of what you said is actually interesting.
@upomega, their social media feed is an embarrassment, there is the obvious Tesla tweet, but that was just the latest, remember the “only picture colin was willing to approve”, boxes of Abc19 test ready to go, but go where, to whom, for how much, little titbits of info to keep us all on the line, stockpiling or ordered, paid for or wishful thinking, half-truths that don’t add up to the full story when you take everything into consideration
individual countries may be entitled to buy such tests however:-
"Member States unanimously agreed on a Council Recommendation setting a common framework for the use of rapid antigen tests and the mutual recognition of COVID-19 test results across the EU2. "
It would therefore seem likely that member states will be using tests solely from this list. I hear a lot of people on here saying that UK is only one country and there will be demand from many other countries, but until Mologic gets on that list, then it is unlikely to be used by any of the member states. It is starting to look concerning that Mologic still has no validation at this time anywhere it Europe even though it's been around since before Christmas. Be interesting to know if GAD/Mologic are seeing any traction for sales, but of course as a private company they have no obligation to report.
It is interesting to note that Innova is not on the list, so that would imply Innova LFT are not being used in the EU. Also of interest is the fact that Surecreen are also not on the list.
upomega
I agree, great job by Colin and the team.
Strong Buy
My view is that they have not grasped social media and how it can have dyor consequences if not handled correctly.The othet problem inmv is that the bod are coming across as divided and not united. That is how it feels to me.
Not sure i agree with you with regards to the performance on the top team, the way they manage comms just destroys the company’s credibility with investors, they issue half-truths at best, lies at worse, and change like wind when it suits their agenda, Thats my opinion but respect yours is different.
Totally agree computer909.
My view is that they have done a fantastic job . However they now need to bring in expertise to take this to the next level. But what an amazing job the Ceo and his team have achieved in getting Omega to this stage .
What we need is a number of prime distributors, that have the contacts in the EU/US. Without those on the table quickly we wont get any traction at all, in the current market its no good for ODX to sit back and hope clients will come to them, I really expected them to have at least something of that type to announce on commercial launch , what was the point of a separate commerial launch date if they had nothing further to announce after CE mark?
not to mention hmg puppets. I agree the eu and fda is the key here. That is why we need a large pharma on board together with large institutions. Otherwise we will fail inmho.
MHRA are useless. Take far too long.
@upomega: EU population 450m, USA population 330m, UK population 66m, with to issues we have in the uk with getting any market traction, the EU/USA has to be priority markets
the only validation the world wants is mhra. all other proffesional bodies such as the fda and eu . let alone other countries are pants. u.k are the best.
Or do we think the FIND study meets criteria C?
So based on the three requirements to get on the list
(a) Carry CE marking;
(b) Meet the minimum performance requirements of = 90% sensitivity and = 97% specificity; and
(c) Have been validated by at least one Member State as being appropriate for their use in the context of COVID-19, providing details on the methodology and results of such studies, such as the sample type used for validation, the setting in which the use of the test was assessed, and whether any difficulties occurred as regards the required sensitivity criteria or other performance elements.
Do we take it no Eu country has validated the Mologic test in the 5 months since it was CE marked?
individual countries will still have an option to buy such tests. The eu will not and cannot act to block such purchasses . . i.e due to trade deals which have already been established post brexit.
Sorry Twatcher got distracted by my hope of a Launch tomorrow. - it could happen... maybe... perhaps...
It doesn't mention Mologic I read something linked to it incorrectly. Does this mean the EU will be effectively locking out tests if 3 member states don't agree? I couldn't get a postable link from where I found that info.
Ella10 , can you confirm where Mologic is mentioned ?
Where did you see that ? The Omega page says L&G have less than 5%, and an archive of that page back in Jan shows that statment was the same then.
https://www.omegadiagnostics.com/Investor-Relations/Share-Holder-Information
I thought legal and general had a 5% stake?
The company's largest shareholder is HBOS Investment Fund Managers Limited, with ownership of 8.4%
Last year institutional investors owned 56%..
That is also the worry Twatcher. i think Omegas problem is not having a large institutional investor or large pharma invested. Personally i am still hopeful they will get both
there are a lot of asian sourced tests on that list, roughly 30% at a guess.
At least they are not U.K/Chinese . May be in a roundabout way they are as we do not really know how much stock and debt from these companies are owned by the Chinese.
Well if you wanted discussion, you could have provided a link to the document so we all could see it.
Here it is:-
https://ec.europa.eu/health/sites/default/files/preparedness_response/docs/covid-19_rat_common-list_en.pdf
I did an adobe search for both "mologic" and "GAD" but there were zero hits. Where did you see mologic in this document, or can you provided a link to the doc you are refering to if it isn't this one ?
The abbot and roche tests are by far the most widely used tests in Europe with over 20 countries using each.
Total of 80+ tests on that list, with about half of them defined as "mutually recognised (3+ countries). To be far there are several variants from the same manufacturer.