I doubt the TGA is going wait for the FDA for anything. Why create the provisional approval process at all if you aren't going to use it? Makes a whole lot of folks at the TGA redundant and I'm sure that's the last thing they want.
The key aspect with provisional approval is safety and given this drug has been around for decades and is widely known as a well tolerated drug, it ticks all those boxes.
Ann: Paradigm Presentation to Emerging Leaders Conference, page-63
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