Chelsea Therapeutics Issues Statement Regarding Postponement of NORTHERA(TM) (Droxidopa) NDA PDUFA Action Date Due to Severe ...
February 14 2014 - 6:55PM
Chelsea Therapeutics International, Ltd. (Nasdaq: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™ (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 (Nasdaq: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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