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Posted On: 08/23/2023 11:52:20 PM
Post# of 148870
The BLA could be resubmitted but it would take going back to primary sources and collecting all the data. Then compiling all that data again for a difficult to do BLA since it uses data from two different trials. Given that the FDA is asking for a new HIV trial protocol they may reject that BLA submission out of hand without even looking at it.
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