FDA delay for ph 3 trial approval, page-11

No Luckyphil1, it was offering some balance.

There is no reason to lazily jump to the conclusion that everything is PAR's fault.
If PAR were that incompetent, the FDA would have found sound reasons to dismiss them months ago.
It's irrational to suggest that PAR gets so many things wrong, but the FDA is the epitome of efficiency, effectiveness, good communication.
Of course they're capable of less-than-ideal standards of work, like any other organization.

We don't know what the problem is, but it's also feasible that it's due to good news, rather than bad.