Sometimes the question is: "An Australian company should be visible in Australia".
With the reduced costs to experiment products in Australia, it would make sense to be visible in Australia, experiment in Australia, get access to funding from the Australian Government, stimulate the research in Australia and get approval to use the drug in Australia in a fast path.
As there a lot of patients sick and with open wounds, a life changing product (considering that death rate after an amputation increase substantially in the five years after the amputation) should find a orphan and preferred path with the Australian regulatory.
If a regulatory body is just made to stop progress, it means that society is following just a very capitalist and not progressive path.
In Russia in the market there are free drugs used by our Astronauts that prove life can change just with product development and make things easier available to the public.
Our military and cosmonauts regularly use Phenotropil®.
We just sell it in Russia, as there is no need to make it available to the rest of the world and pay for trials with Regulatory bodies just made of bureaucratic persons and that sit in chairs just to get paid a monthly salary.
We live in a strange world, and many times things do not make sense.
I really hope that Australia does not fall (but eventually has already fallen) in the capitalistic trap, where convenience of few individuals is more important than the society.
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