D, the data from Gleevac was outstanding, so much so that they halted the placebo arm on ethical grounds and put everyone on Gleevac.
The FDA also goes through phases. Sometimes they let drugs in easier - when they get criticised for holding up lifesaving drugs. Other times they go very slow - after they get criticised for being too easy and letting drugs that are unsafe on the market.
For cancer trials, the documentation can run into 100,000's of pages.
CXS is a bit slow today. Options are glacial.
Mal
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