Detail akcie Vanda Pharma diskuze

:-)))) We are extremely pleased that the FDA has granted tasimelteon priority review for the treatment of Non-24 in the totally blind," said Mihael H. Polymeropoulos M.D., Vanda's President and Chief Executive Officer. "The agency's acceptance of the NDA and decision to place tasimelteon in a category of expedited review are important milestones for Vanda as we take another step toward our goal of providing patients with a treatment for Non-24." The FDA determined the action target date under Prescription Drug User Fee Act (PDUFA-V), to be January 31, 2014. The FDA has also tentatively scheduled an advisory committee meeting to discuss the tasimelteon application on November 14, 2013.