Great post Jake, but does anyone think accelerated
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Posted On: 03/31/2025 6:50:55 PM
Great post Jake, but does anyone think accelerated approval is even possible with such a small trial?
Wouldn’t the survival numbers have to be 15 or 20 out of 28, which would be miraculous. Do we really think the FDA will give us accelerated approval on only 28 people treated unless it was some crazy bizarre survival numbers?
I don’t know the numbers but if I had to guess this group is a “small group” maybe 5-8 people which is fantastic but the cohort is just too small.
What do I know though. Someone who does, please chime in, Kat /Misu?
Wouldn’t the survival numbers have to be 15 or 20 out of 28, which would be miraculous. Do we really think the FDA will give us accelerated approval on only 28 people treated unless it was some crazy bizarre survival numbers?
I don’t know the numbers but if I had to guess this group is a “small group” maybe 5-8 people which is fantastic but the cohort is just too small.
What do I know though. Someone who does, please chime in, Kat /Misu?
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