Some questions you might have had: i) one ex-Us trial and one US trial b/c int'l compliance has been better (including willingness to do biopsies for sake of recruitment ease as well) ex-US. ii) The results will not be compared to Lupron after the fact in the literature. Lupron has been about an improvement of 2 units (i cant recall if it is deciliter or whatever) historically in the literature but if proellex does worse than it did in the prior study (about 2.5) but is still stat sig, it doesnt matter. iii) size of trial is b/c thats what they need to get stat sig, in fact it is 2.5x larger than size of last trial with pts having same criteria. Joe said what i said earlier in that if it was larger he would be criticized for taking too long. LOL. iv) as expected, there arent a significant number of other conditions that could lead to other bleeding in younger women that would make proellex arms results look worse (e.g. GI bleed, cancer) v) current criteria of lower Hgb makes for better p value vs all pts in prior study (higher Hgb women have less improvement) vi) 4 trials start pts on drug next month vii) efficacy data for 2nd round of chronic PII (open label) is due within 30 days (we just got safety data last wk recall).
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