Replies to post #7096 on Repros Therapeutics Inc (RPRX)

[hptaxis]

You appear to be confusing when an individual patient should be halted and when an entire trial should be halted. ?

No, not at all. I state that LFT > 3X ULN requires the individual to stop the drug (either halt or reduce the dose). Once the number, percent, of individuals reaches a certain threshold, the trial needs to be stopped. With Lipitor, 2.3% of individuals at the highest dose (80 mg) exhibited LFT > 3X ULN. Obviously, a near 5% (4.7%) level is one that would be unacceptable to the FDA. RPRX could have continued the trial, but I doubt the FDA would approve the drug at this level regardless of efficacy.

There is a larger question. Does RPRX submit 50 mg data for a NDA? I doubt it. If this is the case, the number of patient exposures has decreased markedly. This will set them back considerably.

Also, the LFTs are something out of the blue. This is now a moot point. This dose is gone. For me, I have always been more concerned about the safety issues of bleeding and procedures.