One of the massive benefits of doing as many trials as possible in Australia rather than USA is the generous tax incentive structure put in place by the Australian government to encourage companies such as Recce to proceed. I don't think this is some dodgy back door method of achieving FDA approval, it seems more like a sensible financial decision by any responsible company board.
"Reports show Australia is 28% cheaper than the US before tax incentives, and 60% cheaper after tax incentives, for early-phase clinical trials"
From
https://www.frost.com/frost-perspectives/australia-preferred-destination-early-phase-clinical-trials/
There are 3 key benefits in outsourcing early phase clinical trials to Australia:• Cost-efficiency: The Australian government offers attractive R&D tax incentives including cash rebates. According to a cost comparison study, Australia is 28% cheaper than the US before tax incentives; and 60% cheaper after tax incentives.• Speed: The Australian clinical trial process allows flexibility without compromising quality. It avoids duplication of processes, saving the sponsors both time and money.• Quality: Australia has a network of universities, independent medical research institutes, clinical trial networks, biobanks, and CROs. Scientific research conducted in Australia ranks the highest in Asia-Pacific in terms of productivity, impact, and one of the most rigorous patent protection systems in the world. Data from studies conducted in Australia can be used to support international regulatory applications, including the US FDA and European Medicines Evaluation Agency (EMEA).
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