This is not a question it is a statement from FDA. I have a problem figuring what it means. Isn't immunomodulatory machanism of action is all Ryoncil is about? To say that it has not been demonstrated in either vivo or study subjects is a huge statement. You said I take it out of context. What context are you talking about ? You said I am ignorning FDA conclusion. I am ignoring anything, maybe if you care to share the conclusion that I may have missed?
FDA ODAC Meeting Material discussion analysis, page-178
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