Biotech Values

[p3analyze]

>>How do you know 306 is not potentially registrational? <<

It's not clear to me whether 306 is sufficient for a standalone NDA. What if 306 were to show benefit in pain and bone mets, but neither 306 nor 307 show a survival advantage?

So I maintain that's most likely registrational as part of an NDA based on a positive 307 trial (which yeilds final result at the same time) to gain a pain response label statement for CRPC with bone mets to differentiate from other drugs in the CRPC arena.

There was a typo in my previous post, I really meant to say without the positive thyroid data which increased confidence in the anti-tumor activities, EXEL would be more reluctant to invest in 306.