Interview with an FDA Process Expert - Pre Questions, page-15

As i wrote in May, my concerns were about the non-clinical data.
Since it was obviously one of the six questions it is obvious that PAR did not address it properly.
From what i gathered they used a nuke dosage level.

So here is what they need to do.

Point out it was a nuke, and make sure they deal with
"what could possibly go wrong"
which is what any half-decent project manager would have done in the first place
(implication for PAR, run another non-clinical trial with three different dosage levels)

Have PR resign from one of his two roles (that's not a new one from me).

Start talking to EU (just once b4).

Not take thirty days to respond, with what appears to be not answers to the actual questions.