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Bavarian Nordic A/S
Bavarian Nordic Has Essentially Agreed a Pathway for the Licensure of IMVAMUNE With the FDA After Successful End of Phase II Meeting
March 18th, 2009
Following the completion of the Phase II clinical development of IMVAMUNE(R), a third-generation smallpox vaccine, Bavarian Nordic has held an end of Phase II meeting with the FDA to discuss the Phase III development. The meeting was a success and there was an open and highly constructive discussion with the FDA. This meeting represented the first ever formal discussions with the agency to license a vaccine under the new legislation of the animal rule - a new regulatory path which allows the efficacy of products for indications like smallpox to be established in suitable animal efficacy models. This marks a major regulatory...
Source: Vaccine Weekly (2009-03-18)
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