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sts66

01/26/17 4:45 PM

#98887 RE: VuBru #98777

in most cases for existing drugs we don't know who those responders are.



Quite familiar with that (unfortunately) - have a bunch of ARNA stock, failure of Belviq was that only a certain % of patients, < 45% IIRC, were "responders" to the drug - they experienced good weight loss and lower appetites/cravings, but for a larger majority of people it didn't do squat.

So back to R-IT failing PE but having some great SE subgroup results, lets say diabetics with high TGs - how do they release that news, how does the market respond to it, can AMRN file sNDA just for that subgroup (I assume yes), and generate decent sales? IOW, could AMRN turn a lemon into lemonade? We already saw how FDA viewed subgroup analysis at the Adcom (JELIS data?) - not impressed.