Replies to post #2302 on Repros Therapeutics, Inc. (RPRX)

[docbanker]

Partner the F'ing drug. Lets stop talking about it for 12-18 months and do it. I say partner it by February or scrap it.

[io_io]

<<<<<"T becomes an unacceptable endpoint">>>>

Not to mention that it was unacceptable last year too.


Personally I think the FDA may have wanted to steer the drug where it is needed - I am most impressed by the AIHH paper that dewophile sourced - there is surely a large market and a REAL need there.

Plus that REAL need gives some protecting from perceived safety issues later on. This looks to me like a great investment and if I can get to a PC I will buy more on Monday.

[dewophile]

"Now all of a sudden T becomes an unacceptable endpoint"

wow - where has everyone been? We've known T was in and of itself NOT an approvable endpoint for ages:

from an SEC filing a year old:

"Unlike testosterone replacement therapies in which efficacy can be shown through mere elevation of testosterone levels back to normal ranges, the FDA has noted that Androxal must demonstrate a benefit over placebo on a relevant clinical endpoint"

for the umpteenth time - why the disparity in regulatory hurdles between androxal and direct T replacement therapies? **Because castrated men CLEARLY require replacement, whereas replacement of men with age-related hypogonadism due to depression of central (hypothalamic-pituitary) regulatory centers remains, in the eyes of the FDA at least, controversial. I knew this A YEAR AND A HALF ago - you all seem to be hit over the head with it all of a sudden!

someone on this board ought to read the 2003 institute of medicine report on testosterone replacement. I don't have it handy, but it says something to the effect of "while T replacement may confer benefit in men with age-related decline in T, the medical benefits remain unproven, and there exist some theoretical risks of such treatment, primarily related to the prostate, and therefore longer term studies are required before such therapy can be recommended, blah blah"

since then there has been a plethora of data supporting T replacement in these men, and safety concerns have been put to rest - which explains why much of the pt pool currently receiving T is in this very population, but I do think everyone ought to quit bitching already. For those assigning a lot of value to androxal all you needed to do was read an SEC filing to realize it was going to be a long shot and a work in progress to find that "relevant clinical endpoint"..I for one am happy with the direction they are taking with the drug - if others think it has negative value because of the added burn that is fine, but I think its worth the roll of the dice beacuse it still could end up being a home run