The Company has requested an End-of-Phase-II meeting with the FDA for NBI-98854 in tardive dyskinesia. The Company will submit a meeting briefing package, along with a proposed Phase III protocol, to the FDA this month. This End-of-Phase-II meeting is expected to occur in June 2014. Upon completion of this meeting, the Company anticipates initiating the pivotal Phase III program of NBI-98854 during the second half of 2014. The Company is currently identifying and qualifying investigator sites for the Phase III program, as well as preparing drug product, aligning support vendors, and finalizing the plans for patient recruitment.
Additionally, the Company has completed appropriate preclinical studies to support the advancement of NBI-98854 into clinical trials for individuals suffering from Tourette syndrome. The Company is meeting with the FDA to discuss the proposed clinical protocols and expects to open the investigational new drug application for Tourette syndrome and commence the clinical program in patients later this year."
IMHO, dumping shares at these prices is extremely foolish.