The panel asked about the efficacy of low dose Qnexa. FDA said Qnexa met the bench mark in all 3 doses. The lowest Qnexa dose produces less placebo adjusted weight loss compared to Lorcaserin. Efficacy argument ends here. Valvulopathy issue has been throughly studied you can also read the data published in NEJM if you don't believe it. Would you give me examples where a panel a month before PDUFA guarantee at the very least there could be a delay.
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