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iwfal

07/14/13 10:48 AM

#164016 RE: hirogen #164015

XOMA

I suppose where I'm going with all this is I don't know how well the primary endpoint in the ph III A trial captures the overall effect that Gev has on the disease. Which goes back to my earlier comment that I'm not sure if the trial is as well powered as XOMA thinks it is.



Not sure I understand your logic? (not being flip). If it is that there is a lot of uncertainty because the Behcets trials were so small, I agree. But would suggest that the median is very high compared to historicals so even with a mark down for uncertainty.... Or is your argument that if IL-1s are the same as TNFs then they shouldn't assume 40%.?

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DewDiligence

07/14/13 12:42 PM

#164021 RE: hirogen #164015

Re: Vitreous-haze metric (XOMA)

From the abstract you posted:

Variance component analysis determined that 87.7% of the variance in grades was attributable to the test item rather than to grader or session.

That’s an impressive degree of objectivity that almost certainly surpasses the level achievable with BCVA (where even a slight forward movement of the body or head can materially affect the measurement by shortening the distance between the eye and the reading chart).