TGA today?, page-329

There is a lot of frustration building around the silence with respect to the TGA. I am also frustrated however fully aware of how these government departments operate. I deal with them intimately in my role and I can say that they do not have to tell you how long it will take and can continue to ask questions until they cover their bottom before providing a decision notice of approval. It can be an extremely frustrating process and difficult for to make decisions when they don't know timing and level of approval. This is also compounded when either the proponent changes documents or legislation changes which happen often. Now in saying all of this I am still of the opinion that the ADO leadership team dropped the ball early in the piece when they solely focused on CE approval. The business world is dog eat dog and in the medical device world even more so, therefore if you are not on the front foot with a well defined project plan and schedule you can come unstuck easily. I hope the board has learnt from this and taken off the speed limiter and commits to not making the same mistakes.
The TGA will approve our test and my gut tells me that when DT said that they added the anterior nasal and medial nasal sample validation tests this would have slowed down the process. I have done this myself in my profession and it happens but it does add time to the approval timeline. Not long now ADO shareholders!!