Quick Facts
FONT-SIZE Plus   Neg
Share SHARE

Chelsea Therapeutics Updates On Northera Regulatory Status, Development Program

Chelsea Therapeutics International Ltd. (CHTP: Quote) has received a written response from the U.S. Food and Drug Administration or FDA to its modified proposal for utilizing data from ongoing Study 306B to support its application for marketing approval of Northera in the U.S. In its response, FDA advised Chelsea that, based on the theoretical potential for certain patients from Study 306B to have been unblinded in conjunction with the reporting of 306A data, the FDA cannot be confident that this information did not influence an amendment of the statistical analytic plan, and therefore believes, as presently planned, Study 306B is unlikely to provide sufficient confirmatory evidence to support a Northera Capsules New Drug Application or NDA.

The Advice Letter from the FDA stated "if an analysis of all subjects enrolled in study 306 after [Chelsea] amended the analytic plan demonstrated a statistically significant benefit on the primary endpoint, [FDA] might regard this as a positive trial." However, as this analytic approach seems to exclude at least 109 patients from Study 306B, the FDA further urges that Chelsea 'design and conduct an additional trial to show that droxidopa has a significant and persistent effect' on symptoms of neurogenic orthostatic hypotension.

Based on FDA's feedback, the company is now evaluating several scenarios that may provide the supportive data the FDA is seeking while minimizing any delays to the planned resubmission of its Northera NDA.

Register
To receive FREE breaking news email alerts for Chelsea Therapeutics International and others in your portfolio

by RTT Staff Writer

For comments and feedback: editorial@rttnews.com

Business News

Quick Facts

Editors Pick
This apparel maker has doubled its earnings per share in just two years and increased its annual earnings forecast from time to time, despite a challenging consumer spending environment. Contributions from acquisitions, efficiency gains from self-owned global supply chain and benefits from 'Innovate-to-Elevate' strategy continue to boost the company's results. Here is a quick summary of the earnings reported after the bell on Nov 20. We have 20+ stocks listed here. The good news is you can skip this step. There is a next move that can make your life a lot easier. Our research team has already done the groundwork for you. All these stocks listed... Design software maker Autodesk, Inc. said Thursday after the markets closed that its third quarter profit fell 81% from last year, as higher costs and expenses more than offset an 11% increase in revenue. However, the company's quarterly earnings per share, excluding items, came in above analysts' expectations as did its quarterly revenue.
comments powered by Disqus
FREE Newsletters, Analysis & Alerts

 

Stay informed with our FREE daily Newsletters and real-time breaking News Alerts. Sign up to receive the latest information on business news, health, technology, biotech, market analysis, currency trading and more.