Quarterly report pursuant to Section 13 or 15(d)

Subsequent Events

v2.4.0.8
Subsequent Events
6 Months Ended
Jun. 30, 2014
Subsequent Events [Abstract]  
SUBSEQUENT EVENTS
SUBSEQUENT EVENTS
We announced positive top-line results from the first pivotal phase 3 trial of Rayaldee. This trial is one of two identical randomized, double-blind, placebo-controlled, multi-site studies intended to establish the safety and efficacy of Rayaldee as a new treatment for secondary hyperparathyroidism (SHPT) in patients with stage 3 or 4 chronic kidney disease (CKD) and vitamin D insufficiency. Top-line data from the second, identical pivotal phase 3 trial are expected to be available in September 2014. Patients completing the two pivotal trials are being treated, at their election, for an additional six months with Rayaldee during an ongoing open-label extension study. A New Drug Application (NDA) submission to the U.S. FDA is on track for the end of 2014.