TITLE

BAVARIAN NORDIC AGREES ON PATHAWAY FOR INVAMUNE LICENSURE

PUB. DATE
April 2009
SOURCE
Worldwide Biotech;Apr2009, Vol. 21 Issue 4, p6
SOURCE TYPE
Trade Publication
DOC. TYPE
Article
ABSTRACT
The article reports on the end of Phase II meeting held by Bavarian Nordic with the U.S. Food and Drug Administration (FDA), following the completion of the Phase II clinical development of IMVAMUNE. The meeting was the first formal discussion with the FDA to license a vaccine under the new legislation of the animal rule and Bavarian Nordic has agreed to follow animal efficacy models and phase III protocol.
ACCESSION #
37135399

 

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