CHARLOTTE, N.C., May 1, 2013 (GLOBE NEWSWIRE) -- Chelsea Therapeutics International, Ltd. (Nasdaq:CHTP) today reported financial results for the first quarter ended March 31, 2013.
- In February 2013, Chelsea received written guidance from the Director of the Office of New Drugs at the U.S. FDA stating that Study 306B has the potential to serve as the basis for a resubmission of a Northera NDA for the treatment of symptomatic NOH. The Company intends to resubmit the Northera NDA in the second quarter or the early weeks of the third quarter of 2013. Chelsea also intends to initiate a new clinical trial in the fourth quarter of 2013, given FDA guidance regarding the potential need for Chelsea to verify the durability of effect of Northera in a post-marketing study.
- In March 2013, the results from Studies 306A and 306B were presented at the American Academy of Neurology's 65th Annual Meeting, where they were featured as part of the 2013 Emerging Science Program and highlighted by the AAN both in a data blitz and press release titled "New Drugs May Improve Quality of Life for People with Parkinson's Disease".