Yes, but in order for the FDA to go down that path they have to hang their hat on something within their framework to justify knocking it back.
Ifmanufacturing gets a tick and we already know Ryoncil has an impeccable safety profile ... the FDA then need to work within their own framework and compare the pros vs cons, with efficacy being the area requiring judgement.
A lot of pros (not gold standard), but what do they have to put in the cons bucket?
Ann: FDA Accepts Mesoblast's BLA Resubmission for Remestemcel-L, page-285
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