6-10 months is for full approval, but as Misiu sai
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Posted On: 01/02/2020 9:40:16 AM
6-10 months is for full approval, but as Misiu said we have fast track and rolling review.
For acceptance of BLA submission for further review 60 days for a preliminary decision is standard. But we have a rolling submission and with the clinical they had the bulk of the data already. I think a decision could be made within 30-45 days.
For acceptance of BLA submission for further review 60 days for a preliminary decision is standard. But we have a rolling submission and with the clinical they had the bulk of the data already. I think a decision could be made within 30-45 days.
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