ODM-201 for mCRPC

Unfortunately, Jerry. This is the very best way.

We cannot predict the future and many of the patients will live at the 53 month projected median needed for a ten years trial to be conducted. It can take three years to accrue enough patients to make the hazard ratios acceptable. 53 months into 36 months would add to 89 months. Then you have to get to where at least half of the men are at the 53 month median. It's a ten year trial.

Many time over in these trials the trials show no improvement in overall survival. It does not mean the drug is ineffective. It can still have a PSA lowering affect like the Phase II trials showed here. But if the drug starts killing the patient or does not outweigh the mortality in the control arm then it will be the value of the secondary end points that will determine if the drug is effective.

In other diseases it usually takes less time. But remember, prostate cancer is one of the slowest cancers. And since this is an AR drug, it has a lot of competition such as the CYP17 drug it is being compared to. Is this a better AR drug? That depends. AR drugs have very similar issues. That's why there is some cross resistance between Enzalutamide and Abiraterone Acetate. But it may be that some genetics play a role and one drug may be better for one patient and the other drug is more effective in another patient. And why neither drug works in yet another patient.

This is where translational science comes into play. And genomic mapping of prostate cancer being mapped to individual cases for individualized treatment plans.