I'm not as confident about PBS approval here in Oz.
With federal cabinet now making decisions independently of the PBAC and also looking to tighten their spending on the PBS, Bronchitol might miss out on a listing.
The previous decision was less than flattering with the PBAC suggesting that Bronchitol had 'uncertain cost-effectiveness' for inclusion on the PBS.
The decision in Europe helps the case somewhat, as would a re-jigged submission, but it's far from a no-brainer.
Certainly in the two articles below Dr Robertson sounds concerned about the potential for a no vote.
http://au.finance.yahoo.com/news/PBS-delays-worry-Pharmaxis-aap-3388934618.html?x=0
http://wotnews.com.au/announcement/pharmaxis_bronchitol_deferred_by_australian_pbac/01173386/
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