Replies to post #3755 on Repros Therapeutics Inc (RPRX)

[iwfal]

In particular the company states the trials are 2.5X bigger than the P2s.

2.5x bigger than the subgroup from the ph iib that would meet the entry criteria for this ph iii.

Why 15 patients in the palceboe arms of the 4 trials, especially when you know many will drop out?

Valid question - did they account for the drop out rate. But note that if the trial is 2.5x bigger and the ph iib drop out rate for placebo was 'only' 30% they are still in ok shape.

Why no SPA?

Valid point - my guess as to the rationale is that it takes months to negotiate an SPA and the whole point of the anemai trial is to get in early. E.g. if the goal of this trial was to save 8 months on the NDA and it took 8 months to negotiate the SPA, ... what's the point? (Not saying it is that extreme a trade, but trying to clarify.).


PS No, I haven't gone native (yet -g-), but just pointing out that there is enough data out there now to understand that some thought went into the trial even if 15 patients sounds wacko. Plus debate is good for the DD process.

[docbanker]

********Firstly, many of the below questions have been answered a number of times.
There are 15 pts in the placebo of the 2 anemia trials- i would encourage you to look at the slides in the Company's presentation. These patients experienced no/minimal increase in Hgb despite even being on iron with a small std dev. No spa b/c it would have slowed down the trial design by months to try to negotiate one. The company is using 25 and 50 b/c of the protective effect of the endometrium as defined by the FDA as a need for consistency to back up the chronic fibroids trials and endo trials from a safety database perspective.

I suggest instead of insulting me with comments like Tony Snow/Bush, you actually get off your dead a** and read the previous answers to your questions and IF you are still not satisfied you should call/email the company for a response. It seems to me you are either lazy or want to keep posting questions for the sake of posting the same questions to create uncertainty.




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Sounds just like Tony Snow interviewing Bush.

How about some real questions?

Why 15 patients in the palceboe arms of the 4 trials, especially when you know many will drop out?

Why no SPA?

The FDA does not like companies to use higher dosages than have been shown effective. For anemmia, why is the 15mg dose not in the P3?

What are the endpoints? In particular the company states the trials are 2.5X bigger than the P2s. So, this implies a composite endpoint of both arms treatment arms, or a P reduction. If composite, isn't that a danger in the fibr. trial? If a P reduction, what?


I know all these issues were beaten to death, so no need to ask. Just present the softballs.