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Article: FDA Wants More On Discovery Labs' Surfaxin Response Letter.
- Article from:
- BIOWORLD Today
- Article date:
- November 3, 2009
CopyrightCOPYRIGHT 2009 A Thomson Healthcare Company. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan. All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)
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Washington Editor
Shares of Discovery Laboratories Inc. dropped Monday, after the company acknowledged that its recent letter to the FDA has not adequately addressed questions raised in an approvable letter the agency issued six months ago for Surfaxin (lucinactant).
"This is not what we were expecting, but it is what it is," said John Cooper, Discovery Labs' executive vice president and chief financial officer. "But we have a really good relationship with the agency, so we will work as judiciously as possible to find out what the issues are and then respond to them."
The company defended its initial response as comprehensive and is optimistic ...
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... ... price dropped below $8.50. (See BioWorld Today, Aug. 19, 1997, p. 1.) Along ... U.S. and Europe," Krawiec told BioWorld Today. Tanner said Amylin's move to continue ... J $36 million from a loan. (See BioWorld Today, March 3, 1998, p. 1.) Terms ...
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