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Biotech / Medical : NKTR Drug delivery Company
NKTR 58.00+3.6%3:59 PM EST
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From: Arthur Radley5/13/2014 10:45:34 AM
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Finally an event that has importance for those of us who have held NKTR for such a long time. The FDA OIC meeting will finally take place on June 11-12. The background info will be made public on June 9th.

June 11-12, 2014: Anesthetic and Analgesic Drug Products Advisory Committee Meeting Announcement
Center Date Time Location
CDER June 11, 2014
June 12, 2014 8:00 a.m. to 5:00 p.m.
8:00 a.m. to 1:00 p.m. FDA White Oak Campus
Building 31
The Great Room (Rm. 1503)
White Oak Conference Center
10903 New Hampshire Avenue
Silver Spring, Maryland

Agenda

The committee will discuss the potential cardiovascular risk associated with products in the class of peripherally-acting opioid receptor antagonists and the necessity, timing, design and size of cardiovascular outcomes trials to support approval of products in the class for the proposed indication of opioid-induced constipation in patients taking opioids for chronic pain.

Meeting Materials

FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA’s Web site after the meeting.
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