Source: https://link.springer.com/chapter/10.1007/978-3-031-34724-5_4
It makes sense that any international sites have regulatory approval at the same time. You don’t want to open an IND or CTA down the track and create a lag in P1A/1B if you can avoid it.
The only thing I can think of is whether getting P1A/1B safety data that is then used for IND may avoid a clinical hold.
IND before Australian ethics?, page-7
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