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sts66

02/23/12 6:20 PM

#1555 RE: JAG626 #1549

Mathematically impossible - Qnexa's PDUFA date is a month before our ADCOM, let alone our PDUFA date - unless you're saying either:

1) The FDA will over-rule the VVUS panel and demand pre-approval CV trials instead of post-approval (unlikely give the VVUS/Qnexa "golden child" status within the FDA, or

2) You're trying to say Lorc will actually be available for sale before Qnexa (assumes both get approved), i.e. Lorc wil beat Qnexa to the marketplace because of all the delays VVUS will face setting up the mail order pharmas, FDA approved REMS plan, etc. - that actually is likely, especially given that VVUS will have to build a distribution channel and sales team from scratch (no partner), while Esiai could have Lorc behind the counters of CVS etc. within weeks of approval, with sales reps knocking on PCP's doors in the meantime.