This thread has been started on orders from @johndprent who loves a bet almost as much as he loves a beer.
Background
The P1a/1b all comers trial will be conducted in Australia and "internationally".
Presumably "internationally" means the USA.
The Australian sites will require ethics approval from the TGA (and governance approval from each site)
The USA site(s) require the FDA's non-objection to a future IND lodged by RAC. Note that the FDA doesn't approve INDs; it either objects or it says nothing.
Both applications will rely on the same data from the RC220 preclinicals, RC110 data generated by RAC and the historical RC110 data.
So neither application can be made until the complete package is ready.
Competition
Participants need to guess whether the Australian ethics application will be made before, after or simultaneously with the IND lodgement date.
Prize
Kudos, and nothing else.
This thread has been started on orders from @johndprent who...
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