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Re: poorgradstudent post# 210626

Friday, 04/14/2017 2:34:15 PM

Friday, April 14, 2017 2:34:15 PM

Post# of 253269
You can read the detailed EMA analysis here:

http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Summary_for_the_public/human/004085/WC500223726.pdf

That's a lot more data than we get as investors in deciding whether approval is likely or not, and nothing there suggests a dosing issue that I can see.

"[A] more robust response was shown [for 4mg] regarding the prevention of structural bone damage in Study JADX, and higher remission rates were achieved for the 4 mg dose versus the 2 mg dose in the multi therapy resistant bDMARD-IR population (Study JADW)."

Peter



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