Moderator - Will the FDA accept the European results to approve arikace for CF?
Lewis - The FDA will not approve arikace for CF based upon those results alone. However, if we have positive NTM results, along with positive results from the longer term CF study due later this year, the totality of those results will set up an interesting discussion with the FDA for the appropriate label for Arikace.
IMO Lewis is banking on the FDA safety and Innovation Act to convince the FDA to approve a label that includes CF, NTM, and non CF Bronchiectasis if the current trial results are strong. Just one year ago Lewis would have never made that statement.
It is also interesting that the U.S. clinical hold for Arikace regarding CF was lifted on May 12th last year. The first draft of the FDA Safety and Innovation Act was written on May 15th, just 8 days later. Insmed chose to stick with Clear 108 in Europe/Canada, but chose nott to begin a U.S. Arikace CF trial. Did the FDA Safety and Innovation act contribute to that decision?