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Last Update: 13-Feb-12 10:14 ET
Chelsea Therapeutics Down 34% After Co Discussed Receipt Of Briefing Documents
This morning, Chelsea Therapeutics (CHTP 3.33 -1.69)announced the co discussed Northera NDA at BIO conference; will update shareholders on several lines of inquiry that have emerged as significant components of the benefit-risk analysis of Northera.
The company announced that during a presentation at today's BIO CEO and Investor Conference president and CEO, Dr. Simon Pedder, plans to provide an update regarding the company's New Drug Application (NDA) for NORTHERA (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 (CRDAC) 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.
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. 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." Dr. Pedder's Presentation and Webcast is Scheduled for Today at 10:30 AM ET.
The company announced that during a presentation at today's BIO CEO and Investor Conference president and CEO, Dr. Simon Pedder, plans to provide an update regarding the company's New Drug Application (NDA) for NORTHERA (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 (CRDAC) 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.
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. 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." Dr. Pedder's Presentation and Webcast is Scheduled for Today at 10:30 AM ET.
