Biotech Values

[hirogen]

XOMA - The biggest risk to XOMA that I can think of is that most of the benefit to Gev is during that down ramp in steroids and the physicians are, understandably, trigger happy I that period. So the placebo exacerbations get censored - leaving the easy to treat patients in the placebo arm and the tough to treat patients in the Gev arm.

I had the same thought. Although they've done the reclassifications, the censoring of placebo exacerbations due to premature rescue is something that can't be fixed. There is going to be some loss in power, which by mgmt's comments they didn't seem to recognize. Consciously or not, they're trying to recover it by continuing enrollment to get those early exacerbations (also belying the cringeworthy refrain of the trial running longer equates to success). The question now is how successful will Servier be in reinforcing site adherence to protocol.

Were I XOMA I'd go back to the FDA before unblinding and point out that their endpoint is clearly not Standard of Care and they should consider a change in the endpoint to something more closely approximating SOC.

If SOC involves trigger happy physicians, they would have to be careful here in striking the right balance in that they don't loosen the criteria so much they end up losing power. I think it's a tough call, but still worth a discussion to share with the FDA what they've learned.