Just from an outsiders perspective I would think you would want things like (depending on go direct vs licensing) commercialization agreements in theory met, size of marketing investments, teams setup etc etc so that once you get TGA approval (if you are confident) then you can hit the ground running. Obviously this can be dicey as TGA denial will mean wasted resources and spend - just ask MSB
Ann: RHY Institutional Presentation, page-15
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