what I find interesting FAR is that the fda gave an interim response (letter) to these lawyers claims (from memory 9 January 2021). An interim response because of the many varied fda priorities. So, really they just responded to acknowledge that there had been a letter sent to them (fda) but have not addressed the contents of the letter (due to being busy). But fda said they would follow up.
There has been no further correspondence to lawyers from FDA since.
weird!
Ann: FDA Accepts Mesoblast's BLA Resubmission for Remestemcel-L, page-989
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