the first resubmission in Feb23 took 14 months to prepare, OTAT gave MSB the green light on their approach in Dec21.
that tells you how much work Mesoblast had to put in and the gap between what Mesoblast had on hand vs what the FDA asked them to have in the resubmission
this compares to what could possibly be a 3-4 month resubmission from when the FDA gave MSB the green light. This is as fast a turn around as you can expect for any resubmission.
it feels like a long time, but it’s actually much quicker than last time. Which gives me confidence that there is less uncertainty in what the FDA have asked compared to the first time around, and what MSB have on hand was essentially what the FDA wanted.
the first resubmission in Feb23 took 14 months to prepare, OTAT...
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