Ann: Quarterly Activities/Appendix 4C Cash Flow Report, page-22

BP analyst was expecting a much smaller trial now for Adults aGVHD based on the peds feedback. Looks like SI is not even proposing that any more.

Makes sense, as it was their original pathway and this proposed trial was for securing adult and peds in one go because of the 2nd CRL issues. Now that they have been likely resolved, it obviously caused a re-think on reg strategy.

So the changes to FDA personnel, FDA guidance and established label extension pathways (I assume, have not read up on this) has meant the original plan is even more high probability than in 2020. Maybe a small phase 4 adult trial, at most?

Will be interesting to see the battle between the trading profit takers and those investors who get the significance of this change.