I think someone is freaking because it's taking longer than expected on FDA guidelines.
It's a bit like when I have HACCP audits .... there is always minor non-compliance, occasionally major non-compliance ... that is completely normal. You address the identified issue/improvement, it is signed off by the auditor, and you move on under full compliance. The goal is not to fail you, rather assist in getting a pass.
We had this in the quarterly, stipulating we had to submit a second round of information and we are now moving forward.
In other word, issue addressed, now moving towards clearance. :
This is where the "second round review" would have taken place in the process
"or ASK for Additional Information". They asked for additional info, we would have needed time to collate and resubmit, we have done this and now expect the process is moving forward as per the guidelines. Given this statement was made in the quarterly on 31st October, this interaction must have completed on or before this date ( 31st Oct ). If we pick a date like 20/10 ( completely random date ), we must be getting very close to the 30 days having expired as per below ( Day 60 to Day 90 )
Let the process run it's course !
