Early look at regulations is Mesoblast needs to lodge an accelerated approval request- 6 month timeline.
Do you have a pathway within CBER regs that allows for faster AA?
Why can't label be expanded instead based on kids and adults EAP- it fits unmet need- mortality- biomarkers- as I said , have not dissected the regs yet.
Maybe this is the "curious" comment- figure out how to bring adults ..................................................
Reg
MSB Price at posting:
$1.83 Sentiment: Buy Disclosure: Held
A personalised tool to help users track selected stocks. Delivering real-time notifications on price updates, announcements, and performance stats on each to help make informed investment decisions.
(20min delay)