Biotech Values

[biomaven0]

What if 306 were to show benefit in pain and bone mets, but neither 306 nor 307 show a survival advantage?

I think there is some overall confusion about what it takes to get an oncology drug approved in prostate cancer. At the end of the day what is required is safety plus clinical benefit - if you can demonstrate that, you can get an approval. Longer PFS in prostate is not, by itself, a clinical benefit - that is what the FDA is now clearly drawing a line in the sand about. A survival advantage is not necessary for approval if you can demonstrate some other clear clinical benefit and you are not adversely impacting survival.

In the 3rd-line population they are looking at (post abiraterone), basically nothing has shown clinical benefit, so there is still a clear unmet need. If they can demonstrate clearly improved pain response (backed up by scans) and there is also evidence that they are not reducing survival, then they have a good case for approval.

At the very least I think EXEL is a good short-term trade here waiting for the disclosures at the conference later this month.

Peter