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Re: iwfal post# 162564

Saturday, 06/15/2013 12:38:17 PM

Saturday, June 15, 2013 12:38:17 PM

Post# of 257262

XOMA—I'll wager you 2:1 (of whatever we're allowed to wager within the rules of BV -g-) that at the first AdCom for Gev that the FDA shows data indicating either (or both) excess infection rate or excess severe infection rate for Gev. It won't be stat sig in any one trial (which is the fig leaf behind which management self-deception hides the unpleasantness) - but will show up in multiple trials.

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.

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.

Of course, XOMA might not be an independent company by the time these questions are answered.

*EYEGUARD A&B, EYEGUARD A&C, or EYEGUARD B&C.

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