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Posted On: 05/02/2020 3:35:20 PM
Post# of 145254
Agreed that BLA filing is a big milestone, but stating that it could be approved any day is not accurate. We still need the FDA to formally accept our application. And to say that 2/3 of the BLA could be reviewed in a few weeks, is unrealistic, especially now when the FDA may be the busiest they’ve ever been. But here’s to a fast review.
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