Whilst I would like this BLA Resubmission to be classified as Class 1 with a two months turn-around, I can't see why the FDA would agree to this? They wouldn't be doing Mesoblast any favour and risks not meeting their KPIs.
So does this Ryoncil BLA Resubmission clearly meet the requirements to be classified as Class 1?
I can't see it. It's not obvious to me.
I see the FDA classify this as a Class 2, and give them plenty of time to beat their KPIs - with all the things that they have done already, as you have pointed out.
FDA - look at us, how good are we to be able to meet BLA Resubmission KPIs
Anyway, we await next week for the formal Ryoncil BLA Resubmission - it's getting a bit more exciting guys.
As the company's transformation is now within sight!
GL MSB'ers - onwards and upwards
2024 Here we go again., page-817
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