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Posted On: 10/06/2020 11:46:30 AM
Post# of 148903
Dumb question here but that's because I'm unlearned in the ways of the FDA. So it seems like if, by some miracle, we suddenly get emergency approval for severe/critical...not just emergency authorization, but approval. Does that make HIV just a label expansion and possibly move things along quicker for HIV? Wondering if that is a possible methodology to the madness that is our initial BLA perhaps a feet dragging thing for a week or two. If S/C trial is told to fill then resubmit BLA. Just curious...
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