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Re: iwfal post# 163772

Saturday, 07/13/2013 1:26:33 PM

Saturday, July 13, 2013 1:26:33 PM

Post# of 257580

XOMA—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 [EYEGUARD A] 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.

Agreed with the proviso that approval based on only one phase-3 trial requires not only a stellar p-value, but also a trial with flawless execution.

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