Ann: TGA Registration Update, page-413

It's not just that, I'm convinced that trial results / sensitivity claims are also fabricated by manufacturers themselves, particularly those from China.

People don't like to hear the truth sometimes. I've been accused of being both an up and downramper.

I think it's probably got to do with both parties, but there's definitely something happening on the TGA's side that makes them set us apart from the rest of the applicants, even though the process should be the same. At this point it's likely that we'll need to produce and repackage new IFUs, unless the current trial removes the need for that.