Published in Medical Letter on the CDC and FDA, July 24th, 2005
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 2 phase 2B trials.
Initiation of enrollment into the expanded access program, which will be for heavily treatment experienced adults living with HIV/AIDS, is contingent on the approval of local...
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