Quarterly report pursuant to Section 13 or 15(d)

Subsequent Events

Subsequent Events
3 Months Ended
Mar. 31, 2013
Subsequent Events [Abstract]  
Subsequent Events

10. Subsequent Events


On April 1, 2013, we made the final principal payment of $2.5 million under the facility agreement dated as of March 11, 2011 with Deerfield.

On April 30, 2013, the FDA issued a Complete Response Letter to our NDA stating that it cannot approve the application in its present form and outlining the FDA’s request for additional clinical data and human factors testing of the training program, as well as recommendations regarding product labeling and Risk Evaluation and Mitigation Strategy (“REMS”). We are committed to addressing these issues and we intend to discuss with the FDA the scope of the CRL comments to obtain clarification and determine next steps.