Gordon Stein, CFO of CleanTech Lithium, explains why CTL acquired the 23 Laguna Verde licenses. Watch the video here.
Yes, yes, do translate the text and see for yourself what it says :
"Lorsque le DMDIV dispose d’un marquage CE, la procédure habituelle de déclaration est disponible ici"
Links to : https://ansm.sante.fr/page/mise-sur-le-marche-des-dispositifs-medicaux-et-des-dispositifs-medicaux-de-diagnostic-in-vitro
"La mise sur le marché des dispositifs médicaux (DM) et des dispositifs médicaux de diagnostic in vitro (DMDIV) s’effectue dans un cadre réglementaire européen. Ce cadre fixe les “exigences essentielles“ de santé et de sécurité auxquelles doivent se conformer les fabricants pour garantir la sécurité et la fiabilité de leurs dispositifs mis sur le marché européen. Le marquage CE apposé par le fabricant est le garant de cette conformité.
Pour obtenir un marquage CE, le fabricant doit constituer une documentation technique présentant les preuves permettant de démontrer la qualité et de la sécurité du dispositif. En fonction de la classe de risque du dispositif, un organisme habilité indépendant (dit “notifié“) intervient dans le processus de marquage CE. Celui-ci évalue la conformité du dispositif et le système qualité du fabricant et délivre, en cas d’évaluation satisfaisante, un certificat de conformité permettant au fabricant d’apposer le marquage CE sur son dispositif. Le marquage CE a une durée de validité limitée. La pertinence de la documentation technique et l’organisation du fabricant doivent faire l’objet de nouvelles évaluations périodiques par l’organisme notifié.
Une fois mis sur le marché, le dispositif est sous la responsabilité du fabricant qui le commercialise. Celui-ci doit assurer une surveillance de ses performances et de sa sécurité, vérifier qu'aucun problème ne survient à l'utilisation pour, le cas échéant, prendre des mesures préventives ou correctives.
Les autorités sanitaires dites « compétentes » sont, en Europe, responsables de la surveillance du marché et de la désignation des organismes notifiés."
Let's take the example of a validation process from over the pond :
https://ansm.sante.fr/dossiers-thematiques/covid-19-vos-demarches-durant-la-pandemie/covid-19-commercialisation-des-dispositifs-medicaux
"Dépistage de la COVID-19 et dispositifs médicaux non marqués CE : les fabricants doivent se déclarer auprès de l’ANSM avant mise sur le marché"
The header is self-explanatory. Only the PCR tests which have NOT been CE marked are required to undergo additional evaluation through a state laboratory. The products which have indeed received the CE mark can be directly commercialised.
Have a good shopping spree tomorrow.
Yet they keep replying to each other, it really has become a saga.
ViedeChien : user name checks out.
Pokerchips (and those who upticked you), these markets have been on stand-by for many months. Are you suggesting that GDR should do nothing more that wait indefinitely for an answer ?
Don't you think that the most logical thing to do, seeing these markets are roadblocked, would be to try and shift the company's products somewhere else ? For example, in the EU or in ZA, where the tests are already approved for commercialisation.
To me that's Business 101 and it is puzzling that some people would find this expectation of a Plan B irrational.
allah4uk
10:31
John2015 read my post again with your finger, maybe your thick skull will get it right this time.
I have never commented on NCYT's financial health.
Pokerchips, you don't have to switch sectors to receive more frequent information.
Bean could do something as simple as explaining where else he's trying to shift its growing stockpile of tests, but since he's leaving shareholders in the dark, many will assume that he's sitting on his hands while waiting forever for approvals that never seem to come.
Correction : the company has no LEGAL obligation to provide more than a handful of RNS per year.
The real question is whether shareholders should be content with these mere legal provisions.
This is obviously a rhetorical question.
Yet just yesterday the rabid rampers were praising David Bean and his management.
According to them, that the company refuses to update the market is perfectly acceptable - only "derampers" would whine about that.
It seems that NCYT's confirmation that it has huge amount of money owed by the DHSC is sending chills to other coronavirus stocks, most on them being dependent on the UK gov.
"A lot of retail are dumb…
Can’t bare the volatility"
Ha ha oh wow, you couldn't make it up ! Oh the irony. Totally in line with the character, though.
Yet another useless thread.
You don't explain why, so your thread is pretty useless.
Cringey ramping thread.