@RickyHI was under the impression that a rolling review duly prepares the BLA as its five segments are examined thoroughly beforehand each separately first and then all together for consistency purposes. Also this is not a totally new therapy as it is offered in Japan and the US (“compassionate” use). Don’t you think this hedges some of the risk of delaying approval compared to a classic BLA filing? Thank you for your caveat, you certainly know better than I do.
Ann: Results of Meeting, page-44
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