TGA Blueprint, page-4

Comments on here suggest that the TGA response is somehow catastrophic, or bad news, which is a predictable response from investors who aren't familiar with medical jargon, regulatory risk mitigation processes, red tape etc. Perhaps that's why it wasn't released to the market?

Looking beyond what initially looks like a daunting long list of details, it actually reads to me as a fairly standard set of thorough questions and requirements, all of which will have solutions and answers. I regard this as part of the process, and a decent step forward towards approval in Australia in my book.

Clearly I'm not the norm though!