Replies to post #162571 on Biotech Values

[iwfal]

XOMA

For XOMA shareholders who are long when an advisory committee is convened, say, 18 months from now, revelation of an aggregated imbalance relative to control arms in infectious-disease AEs/SAEs may not be a deal-breaker if the efficacy data are clear-cut and there are no major glitches in the two pivotal trials* to support the BLA.

I agree and have never taken any alternate postion. BUT you were disagreeing that it is even a likely truth (that they have an excess infection rate).

And as a recap - the only reason I brought it up on this board is that it likely **is** relevant to acne. Either forcing bigger trials or impeding approval in more severe ways. And you have consistently disagreed - saying a) that there was no reason to believe there was an excess infection risk, b) if there were it wouldn't impede acne approval because the primary extant treatment is so noxious.

A more pertinent bet than the one you propose above is whether Gevokizumab will be approved for uveitis (the lead indication) and whether it will garner strong commercial uptake in spite of any presumed restrictions/warnings in the label pertaining to infections.

Not interested - because, as I noted above, I agree that any excess infection risk is unlikely to severe enough to impede approval or use when the alternative is blindness. And note that my position regarding uveitis has never been any different than this.