Replies to post #147979 on Biotech Values

[poorgradstudent]

EXEL:

What would have been the reason to call the ODAC in the first place? SAEs? Its not as if there was only a 2 week difference between the drug and placebo (eg ridaforolimus)....the Cabo arm showed quite a large improvement in PFS over the control.

I think we're all guessing at this point.

They could have scheduled the ODAC simply as part of the default review procedure for a new chemical entity, but then going through the application they feel they no longer need additional input?

Again, this could be because the data are such a mess as to be indecipherable (i would think this scenario gets RTFed), or so straightforward enough that there is no ambiguity as to what they show.

I'm just reluctant to address non-clinical elements (CMC, etc...) as reasons for postponing ODAC simply because those parts of the application really aren't in the discussion during a panel.

edit: Maybe Dew can set up a poll if iHub still supports them.