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Biotech / Medical : Neurocrine Biosciences (NBIX) -- Ignore unavailable to you. Want to Upgrade?

To: tom pope who wrote (1604)	6/23/2006 10:25:40 AM
From: software salesperson	Read Replies (2) \| Respond to of 1834

although pfizer’s DD and regulatory support to someone who has never dealt with the fda before have been mystifying, it’s useful for those contemplating a purchase of nbix shares at this point to focus on some of gary lyons’ remarks: 1/03 the gnrh data gave him the same proof of concept confidence that indiplon did 4/24/06 he said that the dea letter was drafted, floating around the agency and ready to be signed 4/24/06 he refused to answer any questions about the fda dialogue 5/2/06 he characterized the fda dialogue as "routine" (presumably he felt more confident than on 4/24 ; but he’s never done it before - - how would he know what “routine” is? ) 5/16/06 The FDA indicated that they did not have an opportunity to review all of the information submitted during the NDA review cycles. (translation: it’s the fda’s fault) 6/15/06 The FDA Approvable Letter for indiplon 5 mg and 10 mg capsules requested that the Company reanalyze data from certain preclinical and clinical studies to support approval of indiplon capsules for sleep initiation and middle of the night dosing. 6/15/06 The FDA Not Approvable Letter for indiplon 15 mg tablets requested that the Company reanalyze certain safety and efficacy data. The letter also questioned the sufficiency of the Company's objective sleep maintenance clinical data with the 15 mg tablet in view of the fact that the majority of the Company's indiplon tablet studies were conducted with doses higher than 15 mg ( ??) . Additional clinical data will likely be required. 6/22/06 the sales force is a valuable asset that we’d like to keep so we’re looking to either (a) acquire a neuro company, (b) in-license a neuro product or (c) co-promote a neuro product. The fda’s standards changed (translation: we did nothing wrong). He thinks that the next partner’s deal could be equally as strong, if not stronger, than pfe’s. 12/06 the final ignominies: biotech ceo of year award permanently moved from si nbix thread; lyons stripped of 2001 and 2003 awards his arrogance, overconfidence and lack of contrition have been obvious to me for a long time. Message 21042910 unfortunately, not until recently did I realize to what degree it colored his judgment. And, more importantly, at this point I wouldn’t believe anything he says. sales