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Biotech / Medical : Neurocrine Biosciences (NBIX)
NBIX 145.00+2.2%Dec 19 9:30 AM EST
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To: zeta1961 who wrote (1610)6/24/2006 2:47:32 AM
From: Robohogs  Read Replies (2) of 1834
 
I have been thinking about this some more and going over some of the commentary. It seems like some folks are claiming this is simply an efficacy issue and the FDA would not bridge the IR 10 mg and the MR 20 data. This cannot be the issue I would not think or the FDA could probably issue an approvable but show me more data letter. Doesn't this have to be more than the PSG study? Doesn't it appear safety-related - i.e., why did they not apply 20 mg dose (amnesia issue?)? And as someone posted earlier, can you believe anything they have said? They were guiding for launch a few days after PDUFA date and then they get extended and then this.

It would seem that IR is a slamdunk approval and that it should be able to garner better share than Sonata and similar share to Rozerem's eventual levels. That would seem to make it a $150-200 MM drug. If I were NBIX, I would use PFE money to get the IR approval and start on MR studies and then sell the drugs to a specialty guy (FRX, SGP, others who have excess detailing capabilities?) with extra milestones/royalties if MR is approved. What is wrong with this analysis? And why would PFE dump this - competitive window is much worse obviously but it seems safety may be at issue.

Jon
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