Ann: FDA Schedules GvHD Pre-License Manufacturing Inspection, page-207

Depends on when the date is set bud. According to this articleinspection should be carried out within 60 days from the date the respective request has been received by the authorized department of the FDA.

I am only guessing within 60 days from "the respective request" date could be the initial BLA application, or BLA acceptance. Unlikely from now - however if it was, 60 days means May.

The 'mid' point could be any of that as I interpret it.

I'm sure others with better sleuthing skills, interpretation of above and patience may be able to narrow down a timeframe more accurately than myself.

Either way we can establish that from CBER's own SOPP (linked below) that they are certainly not looking for an additional study:

SOPP 8410: Determining when Pre-License/Pre-Approval Inspections are Necessary