Last time the BLA was resubmitted, the announcement included what was provided to the FDA.
I expect to see a similar summary this time around and then we can continue the debate on 2 vs 6 months.
As the classification would depend on what is provided to the FDA, we'd need to see the description of what's being provided to the FDA via an official announcement before we can have a meaningful debate.
2024 Here we go again., page-823
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