Because,
The FDA requires that the potency assays that are used for a phase 3 clinical trial, are suitable for use as potency assays for phase 3 trials. ( They are approved as potency assays for the trial only ) This does not mean they are suitable for commercial sales or approved or appropriate for commercial sales, or that they should not be further improved after the phase 3 trial.
Interesting MSC's Article, page-21
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