Replies to post #1947 on Repros Therapeutics Inc (RPRX)

[rfj1862]

>Discussing the relationship further and potentially doing more studies that show a (+) correlation between low T due to pituitary failure and things like high glucose or other wide spanning metabolic abnormalities means two things: on the negative perhaps an additional US study teaing out these relationships prior to the pivotal two PIIIs<

There is zero chance that they would be required to do an additional study *before* the phase IIIs to examine the effects of Androxal on metabolic end points. Metabolic end points are very likely to be included as secondary end points of these studies and/or the primary end point of a smaller study that could act as the foundation of an sNDA and expansion of the market for Androxal.

In fact, I would not be surprised if they conducted a small, quick proof-of-concept study to enhance the sale value of Androxal and left it to future partners to do a pivotal.

[croumagnon]

My take is similar to your take docbanker but I am a bit more enthusiastic about the press release than you are.

The fact that QOL is out is a huge plus for RPRX. However the fact that they did not specify yet what the specific endocrine endpoints are makes me a bit confused. Moreover, I am not clear as to what impact these endocrine endpoints would have on approval. For instance, what if the trial shows statistically significant results regarding Testesterone but not with respect to the endocrine endpoints? Does that mean we do not get approval or does it simply mean that we get approval but for a narrower indiction as far as labeling is concerned...

As to whether or not they will have to run another phase II trial before proceeding with their phase III, that is a big mistery at this point and the press release can be interpreted both ways. Perhaps they simply want to suggest the endocrine endpoints after some thought or perhaps the FDA wants some confirmation based on a quick phase II trial, I am not clear which is the case.

Overall however, this is a huge positive for RPRX and should reflect in the behavior of the stock going forward. Perhaps the stock will not react instantaneously to the news because of the possible need for an extra phase II, but when you take the larger market potential into account as well as the lack of QOL endpoints, it will be clear to most with time that RPRX is getting ready to partner Androxal and the stock should move well past $15 within a short period of time. In fact, given the low float, I would not be surprised to see us cross $20 before year-end, especially if a few analysts jump on this badwagon...

Tomorrow should make for some interesting trading. Currently, my plan is to be a buyer for any price under $12 but I will wait to see the market reaction in the morning before jumping in because I am already very long RPRX... However, the one thing I will certainly do tomorrow is to unload the Puts that I had bought for insurance protection because I expect those to eventually expire worthless...