The good old FDA ignored the panel eh Whytee?
I agree with your comments - they had some concerns but still voted to approve .
Follow up , but approve for now
Give us something for the unmet need
Give us something less toxic
Give us something safe
Give us something that's demonstrated better efficacy over Rux
Long term survival data validated Adcoms 9-1 vote.
It should have received approved with a confirmatory trial
For some reason, only known to yourself, you (and Doc) dismiss the long term survival data . Here's a link where Dr Kurtzberg acknowledges that the survival data is "more legit" as it did not come from Mesoblast .
https://www.onclive.com/view/dr-kurtzberg-on-long-term-os-for-remestemcel-l-in-pediatric-steroid-refractory-agvhd
Hindsight is a wonderful thing, the FDA got it wrong , the bottom line is that the drug did work
Reg
ODAC August 2020 event materials, page-16
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