This discussion needs to be bumped.
You are correct. It is the elephant in the room that FDA must address.
Approving Jakafi which is the SOC on the basis of a single-arm trial, with lower efficacy and WAY MORE side effects.
Let's remind everyone what they are.
Compare this to Remestemcel-L which the FDA has acknowledged that there are NO safety issues.
Ruxolitinib vs Ryoncil, page-2
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