(Total Views: 433)
Posted On: 03/19/2020 2:04:33 PM
Post# of 153905
That is very very likely what happened. The FDA made a decision and including some new info they didn't have included in their write-up. For example for BLA part 1, they said they were ready, but then said FDA wanted additional pediatric data for mono therapy, which took a couple more weeks to add, which they included and submitted.

