Biotech Values

[turtlepower]

VVUS - Here's what AF posted on his blog at the 10.36 mark

FDA going over efficacy of qnexa... makes note that low dose qnexa didnt meet statistical hurdle for weight loss. overall, however, the efficacy of qnexa satsfies the fda benchmarks for weight loss.

I think if the statistical hurdle wasn't met then the low dose is not approvable. The FDA review docs states the same.

As for ARNA's AC meeting, No I don't have any examples so perhaps its exaggeration on my part that there could be a delay. Of the biotechs i;ve followed only two, ITMN and SVNT, have had AC's. ITMN about 2 months prior to PDUFA and SVNT about 6 weeks prior to PDUFA. Both PDUFA's were met though. However one would have to be a very confident investor to assume that the FDA would digest any info gleaned from the AC in 5 weeks and give a positive outcome. Of course it could also mean that the FDA is positive about lorcaserin and just needs a thumbs up from the panel. Finally one has to consider that the FDA wouldn't approve pirfenidone because of efficacy issues. And that was for an indication more serious than obesity.

ps : no position in ARNA or any obesity stock for the last few months.