Ann: TGA Registration Update, page-328

I'm very frustrated with how long things have dragged out as well, but I'm not pulling the plug just yet. All we need is this TGA thing to be over and the gates will open to much more. I'm sure they've learnt from the last 2 years how not to do things in the future.

I would also love a detailed explanation of the exact issues and how the back-and-forth communication has transpired.

The biggest question that I have is exactly why another trial is needed. That would answer a lot.

Can't remember the exact wording, but if he said "working with TGA / finalising requirements", that sounds like the TGA itself doesn't even know what it wants. It could also mean that ADO were finalising what they needed to submit. But in that case, why the need for more data now? None of it makes sense.