i just went through two FDA documents. There are concerns about product batch consistency; mechanism of actions, basis of null hypothesis that was set 45% and durability of response where they said MSB doesn't have complete data. FDA assertions that efficacy of successful trial must be looked in conjunction of other two failed trials using same products is bit concerning to me. Saving all technical Jargon, MSB basically said those failed trials were for different populations segments so we cannot compare and product quality has improved significantly since MSB took over from Osiris .
Honestly, when I started reading documents i was all negative but when I reached at the end there is positive too. Most of all, MSB reached primary endpoint and this disease have no treatment at all; so i'd hope outcome would be positive and it might be approved with conditions that they would conduct further trials.
Therefore, most likely outcome- Conditional approval and likely would be full approval but I don't think they would reject at all.
I might have misunderstood so u can do your own research.
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