I believe the timeline may largely hinge upon whether another...

I believe the timeline may largely hinge upon whether another round of questions are raised.

If more questions are raised then the company will need time to consider and respond... and the FDA will then take their time to review.

If on the other hand no further questions are raised then fingers crossed it's just a rubber stamp.

Interestingly the company has been advertising/recruiting staff at differing levels in anticipation of production being ramped up. In the absence of any other news this in itself would seemingly indicate that the board are quietly confident of approval in the not too distant future.