Based on this progress and its patient enrollment projections, Catalyst continues to expect:
- to complete enrollment of 36 subjects in the Phase III trial during the 4 th quarter of 2013; and
- to report top-line results from the double-blind portion of the Phase III trial during the second quarter of 2014.
- to submit an NDA for Firdapse in the first quarter of 2015;
- to obtain approval from the FDA of such NDA by the end of 2015; and
- to commercially launch Firdapse in the first half of 2016.