Ann: Update on FDA Meeting for Remestemcel-L in Paediatric GvHD, page-36

This adds further to my confusion...

"Mesoblast will provide these new data to OTAT, and address other outstanding items as required for the Biologics License Application (BLA) resubmission"
This reads like another meeting with OTAT is a pre-requisite, that is required, prior to the (BLA) resubmission

VS

"Mesoblast continues to be in a well-established process with FDA’s Center for Biologics Evaluation and Research (CBER), and if the resubmission is accepted, CBER will consider the adequacy of the clinical data in the context of the related CMC issues noted above"
This reads like the CBER will evaluate the CMC issues as part of the (BLA) resubmission

So which is it???