I tend to agree with other comments on this point.
ie - if you were the little old TGA would you for the first time ever (if I'm not mistaken) approve a non oncology / life saving type drug only to find out 3 days later (for example) that the FDA won't allow us to go to P3?
so why not wait for fda and if they are good to go then the tga has air cover to do something novel.
it's a theory. who knows if it's right.
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