My understanding of the rolling BLA is that they check that each section has the information required to make a decision. They will not make that decision until all parts are in. I know of one submission to FDA that was deemed to be complete, but on review of all sections was rejected as not enough information to give approval. This process can be frustratingly slow. Trying to give timelines will likely set up for disappointment.
Ann: Results of Meeting, page-43
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