This criticism has about as much merit as the incidence of lipid accumulation in macorphages in the rats. The statistical methods that the FDA allows are weak anyway (standard error versus standard deviation). The importance of Arikace is the single dose per day to get an equivalent therapeutic effect to TOBI. I commented when the data first appeared that the FEV1 primary endpoint was not as pronounced as with the Phase IIb trial, but the difference there is 28 days of Rx to 56 days of Rx. But the main point, therapeutically, is to get as many inhalational sensitivity discs of different inhalational antibiotics on to a pour culture plate of Pa and see which antibiotic creates the largest zone of "no bacterial growth" among the test discs on the culture plate. The antibiotic with the largest kill zone will be the first choice antibiotic, then the second, then the third, etc. That is the primciple behind prescribing an inhalational antibiotic. I just hope that INSM is better at answering any FDA questions than they were about answering questions about foamy macrophages in August of 2011. That is why Whitten and LaBella are no longer at INSM. They underwhelmed the FDA with their knowledge of the "obvious science."