Replies to post #3545 on Repros Therapeutics Inc (RPRX)

[io_io]

iwfal - questions about your question:

<a) What are the differences in the entry criteria for the ph iii vs the ph iib - if any? >

You know in this Anemia trial, the patients are headed to UF surgery later ? Obviously not in the UF Phase iib

<b) For the ph iib subgroup with anemia measurements what were the baseline characteristics relative to the ITT group. >

Hard to know if you are referring to their blood levels at baseline - obviously the main characeristics were UF symptoms.

<c) What, exactly, is the endpoint for the ph iii? >

I believe the measure for Anemia is blood count (now I realize I dont know quite what that is - help - red cell count maybe) - but I beleive the endpoint is basically getting the level back up above the Anemia level (what was it, 11 decalitres or whatever ?)

<d) For that endpoint, what was the observed efficacy in the ph iib? The p value? The arm sizes for the subgroup with anemia data? (Note that this is ordinarily what you would see in a published trial) >

You could look at the presentation in the iBox - I would but I am not sure it is highly relevant.

The very fact that almost all the OTHER patients stopped bleeding makes it intuitive that both the sub-group and the rest count in the decision-making.

<e) What efficacy did you assume in the powering calculation? >

I bet you will give us the numbers any day now ... :o)

[corpstrat]

Clark and others

At the big picture / lay level, we have Dewophile's confidence that Proellex works in stopping anemia of UF, based on the prior data. Nobody much disagreeing. So we're talking about whether the trials will be so screwed up that they manage to obscure this underlying efficacy, right? (A bit like asking whether the Dems are so self-destructive that they can't beat a Republican after 8 years of Bush and now an economy that's in the tank!) The businessperson's answer has to be that it's unlikely.

Safety, OTOH, really is not yet proven. Anemia with a bloody great (no pun intended) black box against chronic use is a game not worth the candle (whatever that old British mandarin cliche refers to.) Do we have a read on what the Florence presentations may have taught us on the endometrial effects?

Not suggesting that you cease your ratiocination on this PIII, but trying to keep it in perspective for myself and any other non-geeks.