That would be the non-FDA word.
This is their 2nd go at an approval, so if the company resolved the key 7 points discussed and reviewed at the Endocrinologic & Metabolic Drugs Advisory Committee this past May, then the resubmitted NDA 22529 shall be approved, if not, then not.
The #1 issue I would think, is whether the increase in valvular heart disease in patients tested with the drug was successfully resolved. The other key issue had been the tumour growth in rats, but which apparently was not the case in humans.
I say 2nd time around has a higher possibility of approval.
Not surprisingly, shares are dropping ahead of today's announcement.