I think it's important to focus on what will make a difference.
What do you think is more likely:
- that a change in strategy (maybe doing the studies initially asked for and getting more evidence of efficacy) is more likely to lead to a successful submission
OR
- that the FDA will have some change in philosophy, or leadership, or change their policies, in time for MSB to get their approval before their cash runs out?
I honestly don't think either is likely to happen. But I am dumbfounded by where you are directing your attention, and honestly can't imagine the strategy involved.
Ann: Mesoblast Type A Meeting with FDA, page-456
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