They have asked for a meeting, but not heard back.
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Posted On: 08/15/2020 8:19:19 AM
They have asked for a meeting, but not heard back... at the pace this is going, don't expect combo approval before July 2021.
With the additional analyses AMAREX needs to carry out, BLA will likely be resubmitted later this year... Add 60 days for BLA acceptance plus 6 months for priority review, and you see at what timeframe we are looking...
With the additional analyses AMAREX needs to carry out, BLA will likely be resubmitted later this year... Add 60 days for BLA acceptance plus 6 months for priority review, and you see at what timeframe we are looking...
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