Biotech Values

[jb_118]

re: OREX vote.

The panel members are explaining their votes right now. Lots of those who voted "post approval" rather than "pre approval" did so because they were worried that requiring it pre approval would kill the program and/or put a damper on obesity drug development in general. Nobody who has spoken so far seems to think we know all we need to know about the drug at this point.

Most people that felt the drug met the efficacy requirement felt they met the technical FDA definition, but people weren't happy with the FDA definition for efficacy.

There's strong sentiment that a post approval study would need to be a randomized study.

vvus up 10% on the vote.