This message was posted by a user wishing to remain anonymous
As someone who has never submitted an NDA or BLA, I have a couple of naïve questions for the community:
1) Is the PAI/PLI scheduled at the time of the NDA/BLA submission, or sometime after the submission has been accepted ?
2) The PAI/PLI is typically conducted how many days/months before the PDUFA date ?
3) Are you aware of instances where the agency cancels a pre-scheduled PAI/PLI because it sees a major issue (that is not related to manufacturing) with the application during the review ? In other words, if the inspection has been completed, can one assume that there have been no very significant concerns from the reviewers so far?
Thank you so much for your time.