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Re: poorgradstudent post# 191179

Tuesday, 05/12/2015 6:21:59 PM

Tuesday, May 12, 2015 6:21:59 PM

Post# of 252427
As I expressed on Twitter before, I don't think this will be a major issue regardless whether GLPG resolved the issue or not prior to ph3 - I'd agree they likely resolve this per filing. If 24-week data mirror 12-week, they likely choose 100mg/day and 200mg/day for ph3 - LLY/INCY chose 2mg QD and 4mg QD for ph3 while PFE chose 5mg BID and 10mg BID for ph3 (10mg BID not approved). Since male is much smaller RA population (20-25%), it wouldn't be much different from other dose reduction implemented under different circumstances, for example renal impairment to use 2mg QD for baricitinib and 5mg QD for tofacitinib.

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