FDA says hold on to Pargluva!

Pargluva got an approvable letter, it was announced earlier today ~ more safety data is needed. The company seems to imply it's more data, as in, more data, but not new trials. The FDA went against the advice of its panel, and we think it bodes well for patients since there were so many uncertainties. This of course is a net positive for Amylin since Byetta won't have competition from Pargluva (muraglitizar) for some time, call it at least a year for now, but likely considerably longer, if it comes out at all. Safety, safety, safety is the focus right now, which from a patient, HCP, and payor perspective, is exactly appropriate. We expect to hear more on this on earnings calls for BMS and Merck later this month.