Biotech Values

[iwfal]

XOMA - Comments on the info in yesterday's conferene call:

I think the most important reveal was that they have an EOA enrollment criteria for a pain above 50 (presumably that is VAS 100). Both the AMG-108 and the anakinra 3 patient data indicate that IL-1 inhibitors work better in more severe pain patients. That said I think it was the most important reveal primarily because I consider the additional data in Beceits(sp?) to be largely a non-event given how striking the early results (and thus the massive overpowering of the Beceits ph iii).

Now, if they had revealed further details on the protocols for the other Uveitis trials I would consider that more important than EOA because EOA is still a long shot - albeit one with HUGE upside if it becomes the first DMOAD.

On the downside I consider the focus they elucidated on Acne to be interesting - but not yet a strong indicator that they are taking the right path to approval. Talking to the treating physicians is necessary - but ultimately they will not be the roadblock. What is necessary is extensive communication with the FDA - ultimately 'what protocol is necessary to convince the regulators that Gev is safer than the alternatives' is the important question. Hopefully the talking to physicians is just the lead in work to the more important question.

BTW - Regarding Gev and the risk of infection (likely the primary limitation as far as the FDA is concerned) I think it is a good bet that they do have excess infections - since, like most companies regarding AE/SAE when the trial isn't big enough to provide stat sig, they are silent on either infection comparisons or severe infections comparisons to placebo. The only question is what the rate is.