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Re: DewDiligence post# 163767

Wednesday, 07/10/2013 11:19:00 AM

Wednesday, July 10, 2013 11:19:00 AM

Post# of 257257
XOMA - One more post on the topic of the probability of success of the different EYEGAURD trials. Although the company often says that they need success in "only 2 of the 3 trials" I think they are actually being conservative. (Which is a positive IMO).

If, for instance, the active treatment trial gets a stellar p value (e.g. <0.001) then even if the two chronic trials bomb due to confounding from different corticosteroids between arms then I think the drug is easily approvable. And I think the chance of stellar p value in the active trial is good - e.g. if the background rate of spontanteous remission is 20% and the treated arm gets 50% then the p value will be well below that threshold.

BTW - Interestingly the Abbvie Humira trial in chronic uveitis is very specific about ramping down the corticosteroids to avoid confounding - to be entirely off them by 19 weeks. My guess is that Xoma (and Servier) did something similar - but I don't have Xoma management calibrated in this regard so you never know. (There are only 2 or 3 biotechs I would trust implicitly to be smart about such protcol issues.)

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