im guessing that pre bla fda meeting for accelerated approval for lvad and maybe also the pathway meeting for hlhs will happen relatively quickly after the gvhd resubmission is finalised, as they free up some bandwidth. so im thinking that submission could possibly come forward 6 months.
im wondering does silviu newspaper comment regarding fda and the data increase the possibility of a 2 month review.
either way, im not in a rush. as long as we get gvhd across the line
im guessing that pre bla fda meeting for accelerated approval...
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