Chelsea Therapeutics Issues Statement Regarding Postponement of NORTHERA(TM) (Droxidopa) NDA PDUFA Action Date Due to Severe Weather
CHARLOTTE, N.C., Feb. 14, 2014 (GLOBE NEWSWIRE) -- Chelsea Therapeutics International, Ltd. (CHTP) today issued the following statement regarding the U.S. Food and Drug Administration (FDA) Prescription Drug User Fee Act (PDUFA) action date for the Company’s NORTHERA(TM) (droxidopa) New Drug Application (NDA):
“As a result of severe weather conditions leading to an office closure, FDA today notified Chelsea Therapeutics that the goal date for the Company’s NORTHERA NDA has been extended to the next business day, or Tuesday, February 18, 2014.”
About Chelsea Therapeutics
Chelsea Therapeutics (CHTP) is a biopharmaceutical development company that acquires and develops innovative products for the treatment of a variety of human diseases, including central nervous system disorders. Chelsea acquired global development and commercialization rights to droxidopa (L-DOPS), or NORTHERA, from Dainippon Sumitomo Pharma Co., Ltd. in 2006, excluding Japan, Korea, China and Taiwan. For more information about the Company, visit www.chelseatherapeutics.com.
This press release contains forward-looking statements regarding future events including our intention to pursue the development of NORTHERA . These statements are subject to risks and uncertainties that could cause the actual events or results to differ materially. These include reliance on key personnel and our ability to attract and/or retain key personnel; the risk that FDA will not agree that our clinical trial results demonstrate the safety and effectiveness of droxidopa; the risk that the FDA will not accept our proposal regarding any trial or other data to support a new drug application; the risk that the FDA will not approve the resubmitted NDA; the risk that our resources will not be sufficient to conduct any study of Northera that will be acceptable to the FDA; the risk that we cannot complete Study 401 or any other additional study for Northera without the need for additional capital; the risks and costs of drug development and that such development may take longer or be more expensive than anticipated; our need to raise additional operating capital in the future; our reliance on our lead drug candidate droxidopa; the risk that we will not be able to obtain regulatory approvals of droxidopa or our other drug candidates for additional indications; the risk of volatility in our stock price, related litigation, and analyst coverage of our stock; reliance on collaborations and licenses; intellectual property risks; our history of losses; competition; market acceptance for our products if any are approved for marketing.
Contact:
Media:
David Connolly
LaVoie Group
617-374-8800, Ext. 104
dconnolly@lavoiegroup.com
Investors:
Susan Kim
Argot Partners
212-600-1902
susan@argotpartners.com
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