Large Phase lll trial - 2plus year delay
Dilution in the $13 dollar range. No cys fibrosis filing in Europe till 2015 with a mid 2016 possible ruling on a approval. Sales of Arikayce worldwide of 70-100M in 2020.
In addition to other benefits such as the ability to have more interactions with FDA, FDA may initiate review of sections of a fast track drug's NDA before the application is complete. This rolling review is available if the applicant provides and FDA approves a schedule for the submission of the remaining information and the applicant pays applicable user fees. However, FDA's time period goal for reviewing an application does not begin until the last section of the NDA is submitted. Additionally, the fast track designation may be withdrawn by FDA if FDA believes that the designation is no longer supported by data emerging in the clinical trial process.