My sense unfortunately is that approval won’t occur by then.TGA...

My sense unfortunately is that approval won’t occur by then.

TGA publishes their minimum required approval timelines and based on that I would expect it to be closer to 12 months from the initial pre-submission meeting. New novel treatments are also stated to take longer than subsequent product approvals.

However I don’t disagree that there will be further certainty on this process by then which will be helpful to all this.