Chelsea Therapeutics Tanks 40% on CEO Update to FDA Panel Review

Shares of Chelsea Therapeutics

are seeing much pressure during Monday's pre-market session after the company updated shareholders of upcoming FDA panel review on its NORTHERA new drug application. During a presentation at the 14th Annual BIO CEO and Investor Conference president and CEO of Chelsea Therapeutics, Dr. Simon Pedder, provided an update regarding the company's New Drug Application for NORTHER (droxidopa), an overview of key issues identified in the FDA briefing document received by the company and anticipated discussion points for the upcoming Cardiovascular and Renal Drugs Advisory Committee meeting scheduled for February 23rd. "In light of recent communications with FDA, including receipt of a briefing document for our upcoming advisory committee meeting, we wanted to take this opportunity to update our shareholders on several lines of inquiry that have emerged as significant components of the benefit-risk analysis of Northera," commented Dr. Pedder. "A number of these questions relate to previously discussed issues identified for our development program, namely the short duration of our clinical studies, the limited size of our study population given the orphan indication and the challenges in quantifying symptomatic and clinical benefit. FDA has, however, placed increased emphasis on safety data from our long-term extension program and the post-marketing surveillance program in Japan," Pedder continued. "We look forward to the opportunity to address these questions in depth during the advisory committee meeting and to continuing to work with FDA to address any additional questions they may have regarding Northera and our clinical program." Biotech analyst Adam Feuerstein provided some color after the company released its notes. Feuerstein stated that the company is trying to damage control before the FDA Panel vote on February 23rd, which is not uncommon. He also stated that 54% of his respondents to his

predict a NORTHERA approval, while 44% predict rejection. Currently, shares of Chelsea Therapeutics are trading down 40% at $3.01.