For mine the FDA don't want to approve cells therapy as there are to many variables in consistency , efficacy, and batch to batch control for them to tick something off .ijust dont think its an exact enough science and the FDA are not uncomfortable with this.
If you really thought this why would you even hold shares ?
I also can't imagine Dr Krause, who could have chosen a career in any big global pharma organisation he wanted based on his experience, would have joined the Mesoblast team if he thought that ... he did come from inside the FDA so he probably has some idea about their thinking - just sayin'
There are also a number of seminars / workshops and articles that don't support your narrative but each to their own I guess ?
https://www.fda.gov/media/150445/download
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https://www.fda.gov/vaccines-blood-biologics/news-events-biologics/otat-learn
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https://bioinformant.com/perinatal-stem-cell-society-congress/
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