I believe it is part of the FDA process:
- To verify that they've got all the required info
- To notify whether this BLA is under priority review / being fast tracked
My understanding is that one FDA notification will be made for both of these items
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- Ann: Mesoblast Submits Completed BLA for Ryoncil to US FDA
Ann: Mesoblast Submits Completed BLA for Ryoncil to US FDA, page-72
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