Perception of CE marking22 Oct 2020 16:33
thought i would stick a post in here for first time in a while, after the short term nature of the money in the covid sector means volatile movements for covid stocks, thus creating arguments and conflicts between all involved, be it short term trader or long term holder (of which i am the former), anyway this is my only post for now, and is based on the perception of the ce marking from may
a CE marking does not show that the test works, or carries any health regulatory approval for covid 19, the CE marking shows the manufacturer has checked the product meets EU requirements
for various reasons, the WHO and FDA/EUA approvals are taking far longer than they did back in March and April, you only have to look at the WHO reports each week to see how long companies are on there for, they do not get turned around in a matter of weeks
once the QMS (quality management standard) stage is complete (which requires ISO 13485 compliance, which GDR updated in July), the pattern for other companies shows it then takes at least another 4 weeks for dossier review to be complete (GDR is now 4 weeks on from QMS being complete), and based on the prequalification process, lab evaulation is the final step which will sign off dossier review - conclusion? WHO approval is now imminent baring any product issues which would cause delay - also Genedrive has in fact moved through the WHO approval process faster than most, including the likes of Thermo Fisher, so keep that in mind
anybody can check the WHO list of approved tests, it is very small, then compare it to how many tests appear on the application list (there is an incredible amount), just shows how hard it is to get on WHO approved list and the very big percentage who fail the process and never make it
also, for every FDA/EUA submission, the manufacturer is allocated a lead reviewer who can be contacted, so i doubt David Budd is sat waiting and has no idea on what stage we are at with it
if GDR fails as a company selling covid tests, it will be because we do not get WHO approval and FDA/EUA, not because we we cant sell a CE marked product
only takes looking at NCYT history to see how things really got going on a commercial basis after WHO and FDA/EUA was given, their sales in February and March on basis of CE marking included for research purposes (because back then everybody needed to carry out research on what covid testing was), sales for research purposes is not a long term commercial basis