see announcement 11/3. minutes were received..
fda supports accelerated approval pathway for lvad..
now they are planning to have a pre bla meeting, so more feedback to come..
also not sure if we will get minutes from the gvhd meeting, next ann with that might just be bla resubmitted. timeframe was this quarter.
also they were planning to meet fda regarding hlhs but they have a fair bit happening so wouldnt be surprised if this gets pushed back..
see announcement 11/3. minutes were received..fda supports...
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