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Article: Bavarian Nordic Reports Positive Data from First EUA Enabling Study with IMVAMUNE(R) Smallpox Vaccine Candidate.
- Article from:
- PR Newswire
- Article date:
- November 29, 2007
CopyrightCOPYRIGHT 2007 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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WASHINGTON, DC, November 29 /PRNewswire-FirstCall/ -- Bavarian Nordic reports the successful completion of a large, placebo-controlled Phase II trial in 745 healthy subjects who received either one or two doses of IMVAMUNE(R) next-generation smallpox vaccine candidate. The results of this study are seen as the pivotal step on the path to moving IMVAMUNE(R) into Phase III registration trials in order to achieve a BLA for healthy subjects.
This study, together with other Phase II studies with IMVAMUNE(R) in immune-compromised persons, is also pivotal for obtaining an Emergency Use Authorization (EUA). Bavarian Nordic expects to receive approval of the EUA ...