There is a little elephant in the room, at least in my marsupial brain, regarding what data has been used to instigate yesterday's announcement.
If it was only the Mt Sinai from February, then why has it taken 10 months for the fast track to be instigated considering the dire straights of the pandemic? Surely if it was based solely on Mt Sinai, then it would have occurred before now. So, a logical reason is that they have also used more recent data.
Not withstanding the later, then the most feasible reason to consider only Mt Sinai data is the FDA incompetence, which seems just as likely.
As such, I have no idea.
Carry on.
Ann: Remestemcel-L FDA Fast Track Designation for COVID-19 ARDS, page-322
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