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acgood

10/18/13 8:46 PM

#168487 RE: mcbio #168485

the efficacy and safety data are both in same ballpark as tofa:
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/203214s000lbl.pdf

looks solid, need to see the longterm data of course
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jq1234

10/19/13 12:24 PM

#168493 RE: mcbio #168485

VX509 data are very solid, much better than I expected. I suppose the mixed data from ph1a were due to wide range of dose selection in that trial, once dose is narrowed down in ph2b, result improves/stabilizes. The key is longer term data - the study continues - and MRI study, if positive, likely has value to VRTX.

You can't look top line safety number like that, need detailed data presentation to see if there's any trend especially for chronic condition like RA. As of 2.8 vs 1.4%, the difference is just one patient, one out of 70 vs two out of 70!