Ann: Program Update Anagrelide, page-17

If they are working as hard as they state then why have they not submitted the MAA for Zolpimist in Australia

From 20 September 2016 Release:

ZolpiMist™| Oral spray for insomniaZolpiMist has a superiorprofile to market-leadingAmbien® tablet
 Global sleeping tablet market is approx.$2.1bn. Zolpidem has 70% market share
 Rapidly absorbed with detectable plasmalevels immediately following administration
 With FDA approval, most other countriesrequire minimal studies for registration
 Planning to manufacture and register ZolpiMistin Australia
 ZolpiMist is a first-in-class oral spray of zolpidem (Sanofi’s Stilnox® tablet) fortreatment of insomnia
 ZolpiMist has been approved and successfully launched in the US. SUDA hasglobal rights excluding North America

What we need to be told why no MAA submitted in Australia or Europe when they state most other countries require minimal studies for registration