Biotech Values

[NP1986]

If the results presented in the ASCO abstract are true, then I agree that there definitely seems to be a clinical benefit. My concern however is how Exelixis proceeds with pivotal trials to prove that the effect is real. Cabozantinib is very unlike other prostate cancer drugs that have been recently approved, so if they plan to take the SPA route, will the FDA consent to using quality-of-life measures as the primary endpoint? Blinding would probably not be feasible, and thus any quality-of-life measures would be less credible. I'm not sure bone scan results would be appropriate if there is a concern about artefacts.

I am also slightly skeptical of the results presented at ASCO because they did not report bisphosphonate use, which could explain at least part of the pain reduction and change in biomarkers.