Alexza-Staccato lorazepine PDUFA Date follow up

Alexza announced today (Oct 11, 2010) that they have received a Complete Response letter from the FDA.  That they did not get an approval is not a surprise (see our earlier opinion).  It’s also not a surprise to us that one of the concerns that the FDA has regards the delivery device, a new device that has yet to be approved for use with any drug. What is a surprise is the safety issue raised by the FDA regarding pulmonary function tests from 3 Phase I safety studies.  Yes, Phase 1 studies.  Why wasn’t this addressed at the End of Phase 2 meeting?