I think the evidence about the European trial suggests it has already started. I have been wrong before so would appreciate how you know the trial hasn't started.
from the 10th Feb the latest TGA update
"The data generated from these trials will ensure that a new submission by AnteoTech will meet the TGA’s regulatory requirements, as well as providing the Company with data for additional regulatory approval processes, including registration for the EU Common List."
from the quarterly 31st Jan
"The TGA has advised us we must add prospective clinical data to support our test performance claims generated using stored samples to align our technical data with the MDCG guidelines.We are currently collecting this data via trials in Australia and Europe, which will also provide the required data set for entry to the EU Common List and IVDR registration."
"Currently, manufacturers of COVID-19 RATs who wish to be included on the EU Common list require sponsorship by an EU member state and a full European based prospective clinical trial including 100 positive samples and 200 negative samples, achieving a sensitivity of 80% or above and specificity of 98% or above."
so from the quarterly 31st of Jan we are currently collecting data that will satisfy European common list registration. both trials are being run with exactly the same sample requirements. 100 +ve. 200 -ve. they may have had to adjust the trial objectives, but the trial has been going for a month at least IMO....
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