Thursday, November 12, 2020 10:39:10 AM
Afterwards, the confusion continues as he seems to contradict himself, both saying that EUA will be filed within 3 weeks and later stating that only Russian CE Mark submission is on track for 4th Qtr submittal.
This statement further on indicates that FDA EUA and European CE Mark are not on track for 4th Qtr. So which statement is true?
Then, after stating they are in final home stretch, he talks about using the testing to change the meter algorithms. What??? If you change the meter, you will have to retest. The FDA is not going to approve something if you change the reading meter after doing the testing. So, while seemingly very encouraging, this PR is far from clear as to where things really are in testing or final product develpment, as usual.
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