Ann: Trading Halt, page-20

I don't know how submissions to the TGA are administered and assessed, but I would have thought that if there were, along the way, issues requiring further work for clarification purposes that TGA would be liaising with management in regard any requisite action / data that was needed. Now that may or may not have taken place over this fairly lengthy approval period but the fact that the company has been progressively recruiting at a senior level would suggest that management are confident any matters ( if they existed) have been adequately addressed.