I think they tried that already, and the FDA weren't interested. We haven't heard a peep out of SI about what happened at the recent Type A meeting, so you can guess they didn't get anywhere with their complaints.
As for the updated potency assay, the FDA previously "acknowledged that the potency assay had been improved", but it obviously didn't meet their "validated" criteria.
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I think they tried that already, and the FDA weren't interested....
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