Replies to post #3776 on Repros Therapeutics Inc (RPRX)

[Nerf]

I haven't seen anyone say "stop asking questions" I have seen people say stop bringing up the same FUD all day every day.

Does an SPA for the chronic trials bring the market cap to 450 like DNDN, or 335 like MNTA? Why do they need an SPA at all for any of them? Do you think that the FDA is going to nix proellex for anemia? How about for UF? The p value was .0000001 or something along those lines.

I'm curious why this keeps coming up.

[dewophile]

per management the reason they didn't pursue an SPA at the outset is it woudl likely have committed them to a 2 year exposure of drug, similar to the standard set for SERMs. with the holiday periods this translates to about 2.5 years trial duration. i think rprx is going to try and argue that the standard shouldn't apply to proellex given the holiday periods and fact endometrium is refreshed, particularly if they have a couple cycles to show there is no residual drug effect on biopsies during the drug-free interval..clinically this is reasonable, but its not clear to me the FDA will allow the company to forgo this current 2 year safety requirement, but i think rprx didn't want to be backed into a corner ahead of time with an SPA, but rather come to the FDA with some reassuring biopsy data in hand to negotiate this point
just a guess..

[dewophile]

one more thing. you and i and certainly the market would prefer if there was an SPA, even at a cost of a few months to negotiate and maybe 1 year in trial length to meet a more stringent safety hurdle, but lets not forget this is a real unmet need (especially endo with limited options and pts exposed to surgeries and narcotics galore) - its why the FDA left the door open for asoprisnil, and why i feel in my gut the FDA WANTS this or some other drug in the class available in the clinic