I think riquent has little to no efficacy but I wouldn't be suprised to see the fda approve it because of the huge need in lupus and that it appears to be very safe.
Riquent is another example of a drug that went into a second phase III trial based on subset data of a failed phase III. Second phase III also failed, but ljpc went ahead and filed the nda.
La Jolla stock is getting creaned today (-22%) 2 days in front of the pdufa. Seems the bull case centers around the phase IV study, fda approves and ljp has the phase IV study to confirm. Opposite may be true, fda may not want to jeopardize phase IV by approving, esp a weak filing.
I expect an approvable letter and a final decision pending the phase IV outcome.
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