Labelling discussions with the regulator normally occur post approval, if for no other reason than the specifics of the approval will dictate labelling requirements. Not to say of course that MSB will already have pretty much firmed up labelling.
One to remember though - there is usually a few months delay after approval before first sales can occur due to the need to finalise labelling - as much as we may wish it, sales do not start the day after approval!
Ann: MSB Reports Q3 Financial Results and Operational Highlights, page-197
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