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Re: hptaxis post# 7093

Tuesday, 07/07/2009 2:40:49 PM

Tuesday, July 07, 2009 2:40:49 PM

Post# of 8474
"LFT ULN is a well-described safety factor"

Yes it is. Take Lipitor for example. On Lipitor's label it speaks about cases of patients being over 3x ULN. Ranges of APPROVED DOSES range from approximately <1% to 3%. In my opinion, Repros believes that efficacy is equivalent for all 3 doses so why create noise/distractions to dampen the efficacy signal by taking a dose forward that is ~4% when the other 2 doses are below 1%.
The only "beef" that anyone could have that I can see is POSSIBLY that a more rigorous look at the data could have teased this out after phase 2 data (phase 2 is done in part to chose phase 3 dose).
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