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Article: TMC114 Expanded Access Program for People Living with HIV/AIDS to Begin Enrollment in Autumn of 2005.
- Article from:
- PR Newswire
- Article date:
- June 14, 2005
CopyrightCOPYRIGHT 2005 PR Newswire Association LLC. 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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Tibotec to File for Accelerated Approval for TMC114
YARDLEY, Pennsylvania, June 14 /PRNewswire/ -- Tibotec, Inc. announced today it plans to initiate an expanded access program (EAP) for its investigational protease inhibitor, TMC114, in the autumn of this year for people with HIV/AIDS who need the compound to construct a viable treatment regimen. The company also announced that it plans to seek accelerated approval for TMC114 in the United States and Europe through regulatory submissions filed by early 2006 based principally on the 24-week primary analyses of the company's two phase IIB trials.
Initiation of enrollment into the expanded access program ...