So...
MSB now has a Type A meeting in 30 days to discuss getting approval for remestemcel-l in paediatric patients on the condition that it will conduct a randomised trial in adults.
If that's not approved, is there anything else Mesoblast can do in this situation or does paediatric use then get delayed for years until a randomised control study is complete in adults?
What are the implications if;
- There is lower efficacy in adults? Will that matter?
- In what context can remestemcel-l trial in COVID patients be used instead of the need for a brand new study? Or is that not possible at all?
MSB to dispute FDA finding in Type A meeting, page-110
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