@dolcevita - I totally agree that the FDA may well be talking with a forked tongue and multi layer politics are in play.
But I don’t want to hear Si saying that they are all good with the FDA and wish washy working together statements. This cannot drag out a other 2.5 years with only the “working together” statement.
I only want to hear and see black and white firm facts on next actions, dates met and end guarantees - We are following exactly what the FDA are directing and they have assured us that after this study/trial or this term and this follow up time and if we achieve this P value then they will approve us for aGVHD. Full stop.
CEO Itescu needs to go, page-260
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