Repros Therapeutics Inc (RPRX)

[Nerf]

In the acute administration of the drug the patients are all only dosed for 3 months until they stop bleeding and will not be anemic for surgery. 3 months of exposure, period for any one patient. There is almost no (or just plain no) risk of any longer term changes from this short of an exposure. The chronic indication is for 3 months on, one month off, three months on, one month off, ad infinitum so there is more exposure to the drug and therefore we have to watch the endometrial tissue for malignant changes.

The short duration of the trial, and the acute administration is very safe. If they hit the endpoints, with that sized placebo arm, they have a very good case for the FDA to approve the drug. Then the only concern is that if there are too many women who decide that they don't have surgery because their problems went away while on the drug. Or that they just want to stay on the drug because it helps their UF symptoms so much.