RE: Some ramblings13 Oct 2021 08:13
"FDA required in-country studies but could/should arrive soon."
Should arrive soon...how many times have we heard that on this board about something regarding odx ? You may, in your infinite oracle like wisdom decide for others who they should and should not ignore, but what you can't ignore is that the FDA list of products given EUA by the FDA shows that in the last 4 full months they have approved exactly 18 tests, so less than 5 per month. One can imagine they are being flooded with EUA approval requests. Some of those will be wittle down and excluded early on, but their backlog must be substantial....and of course Mologic/Visitect are looking for professional use only, in a country that has announced an immediate requirement for self use and already has numerous tests approved for self use.
https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/in-vitro-diagnostics-euas-antigen-diagnostic-tests-sars-cov-2
"ignore the muppets asking for MHRA approval, only the DHSC can ask MHRA to approve a test". Which ignores the rather obvious fact that MHRA list is being checked to see if DHSC has asked MHRA to approve the visitect test which would indicate it's pending selection as a gov test.
"ODX now have the capabilities, infrastructure, equipment, scientific staff (and agency staff if needed) to produce 2 million tests a week. "
When you say "now", you actual mean since some time in April...right ? The fact of which is self-evident that having the listed capabilities alone does not imply impending production.
You used the word "muppet" a few times to refer to other posters, so it appears your thinking is "arrive on the board, make a hero posting, be dismissive of others, ride off into the sunset". I note all those twitter-esk likes you received, we had a 'hero' on here just the other day who was a one day wonder, he's now being called "bipolar" by those same "likeable" people.