Replies to post #39616 on Biotech Values

[dewophile]

re clinical endpoint:
I vaguely recall one instance off the top of my head where the FDA did reverse an earlier stance of requiring a clinical endpoint..intergel, which was an adhesion prevention product used postsurgically, did show decreased adhesions in a trial but was rejected on the grounds of lack of a "clinically meaningful" endpoint (i.e. reduced pain, GI issues, or any clinical endpoints postulated to result form adhesions). teh company ultimately was able to push the product through the FDA based on the lower adhesion score alone (the product has since been pulled from market)
of course one major difference in this case is that it is fairly well accepted that adhesions predispose to various clinical consequences over time, whereas testoterone level is not univerally accepted as as surrogate endpoint for any clinically meaningful outcomes in this particular patient pool, but the obvious double-standard the FDA has re androxal vs other t-replacement products is glaring
fwiw I'm not all that shocked by the modest move today..frankly i thought share price would have moved sharper folowing the endo PR, and I totally agree the biggest move upward will occur if proellex fibroid data is favorable