Nope, you need to take some reading comprehension lessons.
If Mesoblast can come up with a suitable potency assay, then the FDA will consider the proposal for the trial. NOT "approve", they will "consider the proposal". I would guess there could well be some changes required to the protocol that SI is proposing. And the trial can't start until after the protocol has been accepted by the FDA as satisafactory. Or if it does, then SI runs the risk of another rejection like last time.
Cell Therapy News/Articles, page-17317
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