...yep @LearningEachDay, there are myriad little things that demonstrate zero regulator concern with efficacy, safety or manufacturing characterisation processes but could still be added to a regulators wish-list.
I speculate it's actually a post-thaw stability/ characterization test picking up the newly signed-off CQAs in stock coming out of cryo, & that FDA believes it needs toprotect its rearendsave children's lives. It would dovetail with the new assay tests which FDA have indicated are sufficient for an approval consideration.
And I'd bet MSB would be happy to add an extra assay along those lines anyway.i.e. to keep the FDA happy about the 2-3 years worth of cryo-stored product which will hit the market starting pretty fast after an approval.
Cheers
Have a good one
...yep @LearningEachDay, there are myriad little things that...
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