MSB to dispute FDA finding in Type A meeting, page-379

Yep we definitely talked about both Ruxolitinib (aka Jakafi) and Infliximab around the ODAC meeting.

@otherperspective you can go to town on this, but I thought I'd bring up the comparison that was raised by the members of the ODAC committee re Jakafi, that I commented on earlier.
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Some concerns with the MSB 001 pivotal study was that it was -
1) Single-armed (basically not a randomized controlled trial)
2) Too few kids! 55 only!
3) Day 28 OR (Overall Response) of 70.4% (with the 95% confidence interval range of 56.3 - 82 --> 25.7

COMPARE THIS TO JAKAFI -

It got APPROVED off it being...

1) (Also) Single-armed
2) 49 kids (lesser kids!)
3) Day 28 OR of.... 57.1%.. with a LARGER range of 42.2 - 71.2 --> 29!!!

One wonders HOW did Incyte even get this over the line????