NTM negative culture results both "compelling" and "shocking." Primary endpoint not the main takeaway, but was skewed by unrelated-to-drug patient death and patient missing sample date, etc. Purpose of primary was to "predict" secondary endpoint, since the secondary was not expected to be achieved! And it was!
CF long term results "encouraging." First and only once-daily treatment (that's gotta have some competitors quaking in their boots).
Hoping to file for NTM approval this year in US, will find out from FDA this quarter if it's a go...
Will continue trials with NTM even with approval pathway.
The culture conversion data will be difficult for the FDA to refute because WL has already stated they will still move forward with additional trials, and they will either be in commercial phase next year or 2016. In either case the CF EU outlook for approval is very positive. I don't think the FDA will stop folks on deaths door from receiving drug for NTM, especially with additional voluntary trials. Exciting time for Insmed. Repeated market opportunities in Asia and Japan. Sounds like WL is convinced that Arikase will be on the market within 2 years..........if they are not acquired before, in my opinion. I still believe that there is more than one interested suitor for this future global drug. Are we looking at the next generatuion of applications? Think so.