This is getting interesting and will soon become problematic for...

This is getting interesting and will soon become problematic for mesoblast, if not already.
why?
because for every batch manufactured, some will go to the patient as expected and some gets used for batch testing and release, eg quality, potency, viability.
finally, some is kept 'for future' purposes eg these exact tests that mesoblast keep getting rejected for.
the FDA is now playing with the reserves of those batches used in the trial and I reckon they know this, keep rejecting until meso has none left to test and will simply reject the trial because they've used up all the reserved inventory from each particular batch, 'well you can't prove this and that and that the child is alive because of your drug, you've no batches left'
my gut is mesoblast is looking down the barrel with no bullets left to fire, hence the statement referring to the 'code of federal regulations' once the batches are gone, they're gone and no more tests, assays can be run on the batch.