Biotech Values

[DewDiligence]

With good efficacy [in combination with phentermine], the FDA might be willing to relax on the target population.

I respectfully disagree and think the best ARNA can hope for is approval in obese diabetics.

Regarding tacit off-label promotion, the recently settled Botox case materially changes the legal environment, IMO. The promotion for which AGN ended up paying a huge fine was not for some frivolous or cosmetic indication, but rather for serious medical conditions where Botox was widely recognized as the standard of care. If Lorcaserin is eventually approved with a label for obese diabetics, specifically, I don’t see how it can become a big-selling drug without incurring a substantial legal risk to the sponsors. This, more than anything else, is why I expect Eisai to walk.