That isn't even clear either.
The Doherty Institute started testing already-approved tests on the 16th. That makes it sound like it also applies to their self-test application.
'Additional study data' is also vague. why weren't prior studies satisfactory, what exactly is required? Is it Omicron specific? Does it require results to be broken down into levels rather than a general sensitivity figure? etc.
Ann: TGA Registration Update, page-423
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