Replies to post #3546 on Repros Therapeutics Inc (RPRX)

[iwfal]

The lack of a placebo effect in this indication has already been taken into account in the statistical model that generated the 85% power figure. It is not a distinct, bullish factor, as you suggest.

Agreed that if they based their powering model on the ph iib then a lack of placebo effect is probably taken into account. But note that if the "Evaluable patients" didn't include those who came off protocol then a powering analysis based on the 'evaluable patients' would actually be optimistic.

The most powerful thing going for this trial that is clear from the data WE have is that it is that the drug clearly stops menses - and it seems improbable that that wouldn't have a significant effect on anemia.

PS Does anyone know the ITT population per arm in the phase iib Uterine Fibroids trial - in particular the placebo arm?

Clark

[dewophile]

The lack of a placebo effect in this indication has already been taken into account in the statistical model that generated the 85% power figure.

i know - my point was more along the lines of what clark said when he posted "The most powerful thing going for this trial that is clear from the data WE have is that it is that the drug clearly stops menses - and it seems improbable that that wouldn't have a significant effect on anemia." - i would jsut add that another powerful thing going is that pts with heavy bleeding from fibroids continue to have heavy bleeding when given a placebo. when i look at the chance a drug may not act the same in a ph 3 compared with a ph 2, believability of the moa and efficacy factors in - as you alluded to in a post, jsut taking statistical modeling into account some % of trials in ph 2 will show enough efficacy to move to ph 3 despite that drug having zero efficacy - and that % is more than 5 i might add (and i know you know) because all one needs is enough of a signal - a trend - and not a .05 p-threshold to move to ph 3. i bet if you bothered to look at a distribution of drug performance in ph 3 compared to ph 2, that distribution is skewed bimodally, with a peak at no efficacy (for htose drugs that made it through to ph 3 by cahnce) and a peak at equal efficacy, where i woudl bet you woudl find a preponderance of drugs with establshed MOAs, hard endpoints met in ph 2, etc. so simply stated i belive proellex falls into the latter category, effiacy WILL be comparable to ph 2, and perhaps as important given teh small size of the placebo arm, i believe the placebo arm will perform similarly to the ph 2 as well