Biotech Notebook: Medarex, Panacos, Advanced Life

Medarex(MEDX Quote) held a conference call Tuesday morning to discuss the results from the key trial of its skin cancer drug ipilimumab, and as with Monday's press release, the ratio of bamboozlement to hard facts was, unfortunately, off the charts.

For months now, on conference calls and at investor meetings, Medarex executives have sworn that there was no efficacy hurdle mandated by the Food and Drug Administration for its ipilimumab trials. But it seems clear from Monday's announcement and Tuesday's call that there was such a hurdle -- and Medarex tripped right over it.

The FDA wanted to see an ipilimumab response rate strong enough (probably in the mid-teens) to ensure that the lower bound of the confidence interval was above 10%. That was the primary endpoint of the phase III ipilumumab study in melanoma. ...