Yes agreed. I think many here thought this was simple yes or no question for the FDA -- even for a straightforward case this is a complicated process, if yes the 'label' has to be developed with the agreed indications for use etc.etc. But Ryoncil's approval (or not) has implications (for off label use etc) for the Mesoblast pipeline -- for example if it is approved GVHD what does it mean for the on-going COVID ARDS trial? Is it ethical to continue? How would you feel if you had a loved in that covid trial not knowing if they were getting the placebo or the Ryoncil, when Ryoncil could be prescribed off label?
We just have to trust the team we invested in and wait!
MSB Trading 2020 - a new dawn, page-7571
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