@Zenox @dplane @stockrock & anyone else - we all know that SI is quite a conservative CEO...
So why did he take Mesoblast on a path of the full approval instead of the Accelerated Approval (AA) for Ryoncil in the first place?
What advantages does the full approval have over the AA anyway?
E.g. (my guesses) with AA:
1. Can't apply for label extensions?
2. Reimbursement differs?
3. Harder to get approval in other countries?
Unless the FDA flipped and changed their mind late in the BLA process, then there got to be some tangible differences; otherwise SI would not have risked it.
Mesoblast is (and was) well aware of the importance with Ryoncil being the first FDA approved MSC product and the ticket to commercialisation!
Any thoughts?
BTW - I'm glad we have something decent to discuss now rather than those stupid CAs!
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