and they want to file next quarter,
and mention other outstanding issues,...thought other issue were behind us,
been years in the making, and they want to wait to put in paper work, for me with the so called high level of experts in MSB, marketing etc, these outcomes would already be in place ready to go....how much are we paying them????
while good, i still feel a kick in the guts.
file them next week!!!!
what will the FDA now do, oh sry we made a mistake in our advice come back in a fewmonths time, years
Ann: FDA Notifies Clinical Data Sufficient for Refiling aGVHD BLA, page-15
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