Biotech Values

[p3analyze]

Well said. The SPA seems to have improved the pain response endpoint definition significantly. While the lack of resolved SPA is a disappointment, the number of pivotal studies that proceeded without fully resolving FDA comment is more prevalent than people may think. 306 may emerge as the only study in a while to attain the pain response endpoint as it seems clinical folks at EXEL fully understand the challenge of collecting such pain instruments in a large multinational trials and crafted this smaller study to focus on this endpoint, notwithstanding it remains to be seen whether the phase II pain response data were as robust as what have been claimed.

What's puzzling is how analysts underestimated the complexity of SPA and assigned such weight to it. So was the precipitous drop. The medullary thyroid cancer will get their foot in the door, and would lower technical risk for sNDA significantly imo. Without that, I suspect they will be less reluctant to invest in a 10- million dollar non-pivotal study.

That said, I agree the management's characterization of the event as a surprise is a bit disingenuous - they know all along an OS trial, aka 307, is needed for CRPC indication- and that bone scan endpoint is a novelty that FDA is not ready to embrace.

JMHO