The question to ask is whether these results are better than the results from the previous product trial that received the 9-1 ODAC vote, and subsequently shot down by the FDA. Different disease albeit but it points to how high the bar is for MSB to get their therapies approved.
In my opinion, these results are no better in terms of swaying the FDA’s opinion on stem cells.
There’s only one thing that’s really important here:
The.FDA.Hates.Stem.Cells
Ann: Mesoblast Phase 3 Chronic Heart Failure Results, page-393
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