Maybe, if you look at it from a cursory new investor view.
The FDA approval process is fundamental, but what has changed.
Our understanding of the FDA process or Mesoblast's view of this aporoval process?
Do you think that these issues raised in the ODAC briefing notes are new & is a surprise to Mesoblast?
Mesoblast has a very good relationship with the FDA, and has followed FDA guidance through many years. Why would the FDA leave a key piece of information from Mesoblast, but still ta kbh e them through the charade of rolling review, priority review, EAPs & Covid-19 ARDS trial?
Where is the FDA duty of care to these patients if they have issues with Ryoncil/ Rem-L?
So, again what has fundamentally changed?
Anyone else buy in after todays dip/crash?, page-136
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