Cant see PBS rejecting the application since it has been approved for reimbursment in EU given AU is in a much better economic position (low debt, good growth prospects etc).
From memory.. PBS meeting is being held around the 15th
Below is some listing notes...
Resubmission for Authority Required listing for the treatment of cystic fibrosis (CF) as an alternative to dornase alfa in a patient who has previously failed PBS-subsidised initiation criteria for dornase alfa;
OR
as a monotherapy alternative to dornase alfa in a patient who has discontinued dornase alfa despite a previous successful trial and is considering recommencing therapy;
OR
as a monotherapy alternative to dornase alfa in a patient currently on dornase alfa or where a change of therapy might improve outcome based on clinical global assessment.
###########################
My price targets are..
lead up to PBS - $2
On positive PBS - $2.15
On FDA NDA lodgement (late dec or early jan) - $2.50
On good brochetasis phIII trial results (H2 2012) - $3.00
On FDA approval (H1 2013) - $3.50
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