This is how I read this: 1 week ago, ADO submitted info that was requested by TGA. TGA then subsequently requested for additional clinical data. ADO is now talking to TGA to clarify what the requirements really are. Talk about moving the goalpost! The fact that ADO then elaborate on the clinical study being done right now does not read well. Gathering clinical data takes time.
We do not know what additional clinical data TGA has requested. If it is Eugeni's sensitivity data to Omicron, what if another variant appears before TGA gives the approval? I get that ADO may be held to a different standard as home test kits, so maybe other data is needed. I don't know. But we should be able to charge a premium when all these are done and dusted.
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