For Ryoncil, the best thing to do is have another read of this announcement https://hotcopper.com.au/threads/ann-mesoblast-type-a-meeting-with-fda.7589894/
You will find that the outstanding item is the potency assays - there are no questions on efficacy - full stop!
Let’s not go around in circles on the need for RCT for Ryoncil again - this fruitless discussion has been done too many times!
Mesoblast has to come up with funding, but Ryoncil’s path to approval is clear
Cell Therapy News/Articles, page-17238
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