@col69 I can't see that they would schedule this unless they were sufficiently convinced with the resubmission that they see approval as likely.Having said that it is possible that they are scheduling it so that it is in their busy calendars, but may not proceed with it if their analysis suggests approval unlikely. The last time we were rejected was in the midst of the Covid lockdowns, so they probably couldn't have done an inspection even if they wanted to.
Ann: FDA Schedules GvHD Pre-License Manufacturing Inspection, page-30
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