From memory, they started the AUS paediatric double blind early 2017 so it took them 1.5 years, the US took around 1 year.
They said the AUS adult double blind has 567 subjects recruited as of 27 June 2018 so it's pretty close to being completed and analysed.
From the CR, they are looking at starting the US adult trials this US Winter period so in December.
Yes, both will need to be CE/TGA approved, hence both has/are going through the double blind and independent studies.
As for how long to takes to get approved, 2-3 months seems about right.
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From memory, they started the AUS paediatric double blind early...
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