Graeme,
What you are suggesting is not only short sighted, I'm pretty sure it would be illegal in Australia. I am certain it would be illegal in the US.
If AOD9604 could be legally marketed without government clearance, my God, why spend $50 million to prove it safe and effective and apply for TGA approval? Why not just package it up and ship it out all comers? Your disdain for GRAS is misplaced, BTW. GRAS will permit just that. In fact, with full GRAS status, I think the company could ship an oral version sold by mail order in the US without a partner at all.
My counsel remains patience.
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