Replies to post #3585 on Repros Therapeutics Inc (RPRX)

[dewophile]

quant
i rushed my post - i read slide 10 wrong - i thought on first glance the 12 did better month 1 but worse months 2 and 3 because of the p-value, but it appears the 12 did slightly better all 3 months. my bad, not sure why except it could be explained by differences in the baseline cahraceristics of the bleeding pattern betwen the groups
obviously if the 12 did have >efficacy, i totally agree why then test the 50..i have a feeling the drug is not on a declining portion of the dose-resonse, and 25 and 50 are deemed safer for the endometrium..

[exwannabe]

"its not clear to me the 12.5 mg arm is more effective in month 1."

Is that the question though?

Doesn't the FDA want data (not theory) to suggest the dossage is not more than what is needed to get the effect? Do we all not believe that the 25/50 dose is more to support the endo trial safety wise?

"why add the 50? well this is the one opportunity to really evaluate .."

Isn't that what PAHSE 2 trials are for.

Think hard here dewo. I really respect your opinion and believe that this could be a blockbuster drug in the real indications. But doesn't the anemia trial seam a little odd. Like they are really just collecting safety data points and it's not going to an NDA?