April 2009
Worldwide Biotech;Apr2009, Vol. 21 Issue 4, p6
Trade Publication
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.


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