Quiet or dark period in place. WL has not seen data. They will chat with FDA prior to releasing data. Possibility of acquiring or developing other pulmonary products. NTM target population is anywhere from 5,000 to 20,0000 in USA. EU also large opp. CF steps with EU to begin. Sounds like WL has a plan and a firm grasp moving forward. Place your bets................I like what I heard. And what happened with the Canadian deal yesterday.
Will Lewis said that the recalcitrant NTM population is about 5000, and the number of patients that cannot tolerate the recommended regimen is about 20000. He also compared the recalcitrant population to cancer patients, living miserable lives with very low energy.
Will said that treatment of recalcitrant patients will generally be longer than 3 months, and that the design of the Phase II trial was limited to 12 weeks because it was dangerous to keep placebo patients off of aminoglycosides for longer than that. He acknowleged that an extended study is needed for the Arikace patients over a more typical (longer) treatment period.