Maybe not a 'simple question' as you think. If you go back and read the Quarterly update, or if you listened into the conference call the other week, you will know John alerted investors to the fact that the TGA through DI is currently undertaking a review of 'all' RAT. This includes tests already approved for listing on the ARTG, and those test that have submissions in with the TGA to list on the ARTG. The dead give away is the line below.
'TGA introduced new requirements for suppliers with existing ARTG listings, and for those with submissions for listing, of rapid antigen tests. Applicant were requested to provide additional study data for assessment by the TGA and the Doherty Institute is currently conducting further assessments on all rapid antigen test products at the request of the TGA.'
Long storey short the DI will be undertaking a review of both AT1 POC AND SELF TEST devices. Hence, the scope of my question to the TGA above.
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