Yet another thoroughly comprehensive review, thank you. My only query would be:
Regarding the patent-pending from 2020, surely this would have been provided in the second BLA submission last year, since it appears to meet a reasonable hypothesis of MoA, right? If not, then questions must be asked as to what MSB's management are/were doing.
So if the FDA have already assessed it as a part of the approval process of Ryoncil, then I keep coming back to the key factor for Ryoncil's approval being the FDA's assessment of the adequacy of the P3 trial. Again, what has made them backflip here?
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