I could see the AC possibly going for it, but if they are not underwhelmed by Arena's failure to do the 12 month female rat study as the FDA suggested, the FDA itself probably will be. I would imagine this will be alluded to in the briefing docs, and while the AC might cut 'em slack here, I don't think the FDA will. I'd guess 50% odds of an AC thumbs up, and if they get that, 40% chance of an FDA thumbs up. If the AC gives the thumbs down, the approval odds are 15%. So best case scenario odds are 20%, imo. The BLOOM diabetes trial was a mixed bag, calling it a wash: a little help with efficacy, but did not allay CV concerns. So it's all about the rat studies, and they either cut corners to save time and money, or they were afraid of what a longer duration would show. If they'd just started the 12 month study immediately, they'd have been done by now, or nearly so -- yes, the PDUFA date would have been later, but not 9 months later. The other stuff they've done looks positive, but I think they also needed a positive 12 month study to get to the finish line.
FWIW, I'm with you on the AC panel vote for Qnexa. Thought it would be much closer. Your perception that Qnexa has more severe side effects is probably right, but the FDA at least has some idea of what they are, and can address them to a degree, at least the teratogenic ones. Not as true of Lorca, and the FDA, like the market, does not like uncertainty.
JMHO, Tuck |
