AstraZeneca’s Exanta “Not Approvable” At FDA
Review decision comes two weeks ahead of the anticoagulant’s user fee date and follows CEO McKillop’s comments to investors that “we can’t be optimistic about the outcome of discussions with the FDA.”
Review decision comes two weeks ahead of the anticoagulant’s user fee date and follows CEO McKillop’s comments to investors that “we can’t be optimistic about the outcome of discussions with the FDA.”