Decision to drop adult trial and go for label extension instead shows a clear confidence that kids approval is coming and will save $US5-10m in trial costs, also means cells in inventory can be used on paying paediatric patients rather than in the adult trial which allows faster treatment of kids and saves more cash
That's how I interpreted the company announcement as well.
Mesoblast and BMT must have had FDA guidance on this matter.
Looking good, now lets get the BLA in and get a 2 month or less approval.
Aloha.
Decision to drop adult trial and go for label extension instead...
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