I suspect they may end up with sufficient special use cases that they may get an exemption from a standard trial and the powers that be come up with something else. I am not for a minute saying they get to skip a trial though. They have shown that it is effective in the face of amputation or death in real world use cases. And the drug doesn't kill anyone, as far as we know to date and enough people have had this put through their system
There will be many of these patients just around Australia and I suspect it gets more and more special use cases.
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