I looked further into FDA responses. Acrux highlighted they received "minor Complete Response Letters" from the FDA. Minor means for example, changes to labelling required by the FDA. So I guess Acrux is just waiting for their responses to be reviewed.
Good point regarding partners dealing with FDA.
I'm tending to think the FDA are slow at present as they haven't approved 10+ competitors who have also submitted dossiers for Jublia to the FDA for approval.
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