Ann: Appendix 3B-RAP.AX, page-16

@fumoy

You're kidding yourself with the delay of 6-mths

Everything is on track. Us Pivotal Trial to kick off this week & the first FDA approval (initial product which will be for children) will be this year.

FDA submission per product is 120-180 days. The submissions can be while the US Trials are taking place as we will have a rolling data set of US & Aus patients coming in.

You will then find a rolling FDA approval timeline as each product for each age group (children & adults) will be submitted & approved.

The US hospital kick-off will get the media ball rolling in the US also which will attract major US instos.

$1-$2 by the end of this year is very much on the cards.