I dont think that is possible at this stage, if there were any flaws in the submission the FDA would have flagged them at the mid-cycle review. Worst I can see happening is an extension to the approval date if they cannot agree on wording of the product description or naming, which I cannot foresee being an issue either.
Just my opinion and happy to be proven wrong by others more knowledgeable than me on this stuff.
Cheers
MTC
Ann: Letter to Shareholders - Notice of General Meeting, page-9
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