expect another failure, page-11

Remember this is what NICE issued as guidance and they are very very tough

"Guidance
1.1 Mannitol dry powder for inhalation is recommended as an option for treating cystic fibrosis in adults: who cannot use rhDNase because of ineligibility, intolerance or inadequate response to rhDNase and whose lung function is rapidly declining (forced expiratory volume in 1 second [FEV1] decline greater than 2% annually)
and for whom other osmotic agents are not considered appropriate.

1.2 People currently receiving mannitol whose cystic fibrosis does not meet the criteria in 1.1 should be able to continue treatment until they and their clinician consider it appropriate to stop."

http://www.nice.org.uk/nicemedia/live/12224/61229/61229.pdf


So hopeful while the FDA comes across with some scary questions to answer I hope there's some flexibility in the final decision. God I do hate that word hope though, sounds desperate.