I think Mesoblast have had a meeting with the FDA on HLHS… their latest update has ceased to mention an upcoming meeting and it’s somewhat been de-prioritised… now the next move in heart appears to be for end stage LVAD accelerated approval… offering up new info, that the confirmatory study will be for the larger indication of HFrEF … they are going for it!
could either mean that:
1) need more data / further study before AA for HSLS
2) exemption on the PRV, so they can now go for the bigger end stage/ HFrREF without risk of losing out on a PRV
3) I’m jumping the gun here.. and that meeting has yet to take place
Ann: Ryoncil Commercial Launch Update and Product Pipeline, page-212
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