So I see now you have no idear of the Magic Consortium biomarkers. Time to get up to date. Around 95% of those with a MAB score above 0.29 die within 2 years. Real world data. No need for RCT, fact. Responce to treatment can be measured by MAB score at 7 days. Way better than any Dr. just hopping to see a responce at 28 days. MAB score responce at 7 days is way better prodiction of long term survival. Fact. To test in adults is not a test for children. Could be better to test sheep.
Every FDA approval comes with conditions. One of those will likely be a registar. Real world data for all indications paid for by the insurers supporting lable extensions. Trials become $$ in not out.
So I see now you have no idear of the Magic Consortium...
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