Replying to myself ;-)
One of the 'negative' questions from the FDA is how Mesoblast has set an ORR of 45%
This is a higher bar than what Jakafi had set which was 40%.
Not only that, the results from Remestemcel-L show a response rate of 69.9% (95% CI: 55.2, 80.9)... Jakafi a much lower 57.1% (95% CI: 42.2–71.2)
Rebutting or clarifying these points will be a piece of cake.
It has to be approved.
Ann: FDA Advisory Committee Sets Review Date for Remestemcel-L, page-538
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