It’s difficult to know exactly what the TGA didn’t like, but I have a feeling that it may be that they needed to provide three different test kits by different manufacturers that demonstrate the same/similar sensitivity and specificity. I may be wrong but that’s what I took away from yesterday. Will be interested to see what how much the test kits are sold for in the UK; whether they can produce a meaningful income to negate a CR; and when they can get something published in a journal.
Ann: RHY 2023 AGM Presentation, page-12
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