Biotech Values

[biomaven0]

To date, I don’t think EXEL has presented data that could realistically support accelerated approval in CRPC. Does anyone here disagree?

No, I agree filing on existing data I think is a pipe dream.

But they could still have a very quick path to market - assume a 200-patient Phase II in HRPC with bone mets with end point resolution of the bone mets - it would enroll in no time at all, and could well be stopped very quickly for efficacy if they were to show similar results to what they have shown to date.

I think it is a mistake to extrapolate the FDA's resistance to accelerated approval with marginal (or even respectable) efficacy to their likely reaction to any display of spectacular efficacy.

Peter