I 100% agree with Left-e.
Ask yourself this.
How can MSB submit the BLA without parameters been set for the final potency assay. This would require OTAC input and agreement with MSB. Correct?
So given news of the BLA been submitted we can assume that the OTAC team have sighed off on the finale potency assay. The review of the BLA even though not submitted is in my opinion well under way.
Good luck
banter and General Discussion, page-4776
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