BLA accelerated filing? Never. They don't hand those out willy nilly. This is a weighted decision - based on risk and benefits. Efficacy will be confirmed Fri. That's all they are voting on. FDA pulled some old data to muddy the waters and question manufacture... but a short arm testing program was all that was ever required. You will see.
BLA accelerated filing? Never. They don't hand those out willy...
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