One of their phase 3 studies for NOH did not meet the primary endpoint. They announced during the November 3Q Earnings CC that they were going to be meeting w/ the FDA that month to see if they could change the primary endpoint of the 2nd Phase 3 trial.
From 3Q Earnings PR:
"Our operational focus during the third quarter was primarily on the completion of our two Phase III trials of Droxidopa in neurogenic orthostatic hypotension and these efforts resulted in the reporting of our first study and reaching our target enrollment in the second," commented Dr. Simon Pedder, President and CEO of Chelsea. "While we did not achieve statistical significance on our primary endpoint in Study 302, data from the study clearly demonstrate activity, support the symptomatic and functional benefits, and validate safety and tolerability of Droxidopa in neurogenic orthostatic hypotension. We are currently scheduled to meet with the FDA later this month to solicit feedback on the results of Study 302, discuss what, if any, changes could be made to strengthen then outcome of Study 301, and determine the best course of action to secure approval of Droxidopa for the treatment of symptomatic NOH in the US."
GLTA.
Visit my biotech investing board!: investorshub.advfn.com/boards/board.aspx?board_id=16653
GLTA.
