Fast Track | FDA
Right or wrong, the FDA believes those issues discussed (i.e. assays etc) were not resolved quickly because the company has recently announced they are sending more data in the future. Don't forget after the rolling BLA, MSB spent over US$30M (my best guess) on assays - are you starting see the significance of the minutes of the rolling BLA (initiated 30 May 2019 - that's well over 4 years ago).
As I said, SI and the gang should publish the minutes for the rolling BLA and exonerate themselves. Why wouldn't they publish the minutes?
Another question for the AGM next month. That won't be asked and as such won't be answered. Just a mystery. To shareholders. Not to MSB BoDs and not the FDA.
Ann: Mesoblast Type A Meeting with FDA, page-266
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