Isn't it commercially unrealistic to seek approval in a market that has no requirement? Hardly an abominable business decision.
Why get an approval if the market is not there and the government has signaled it won't be? Executing the TGA approval for a mediacl device and tests is not free, it takes ADO resources and expenditure to execute. Why would any company divert resources away from markets that are viable for one that at the time was not?
Hind sight is indeed a bitch when we dont appreciate the commercial reality we exist in.
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