Biotech Values

[Lewis R Goudy]

>Thus, I infer that the FDA saw something

I don't know, the earlier guidance for SELECT-2 was
"sometime in 2008" so that hasn't actually slipped.
It could be that they wanted a better handle on the kinetics
and dose-response relation
before expanding the scope of investigation to refractory
cases, and didn't consider that (internal business judgment)
appropriately disclosed.