Neurocrine Biosciences (NBIX) Message Board

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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: hmpa who wrote (1608)	6/24/2006 12:32:03 AM
From: zeta1961	Read Replies (1) of 1834

Thanks, makes sense..I'm going through old posts here[this 'case' is feeding my current hyperfocus phase-g-] and found that in January they told investors that the FDA 'promised' action by May 15.. Message 22047219 To complete review of the driving study and the combined package insert, the FDA has advised the Company that the PDUFA dates for the IR and MR NDAs have been adapted accordingly to May 15 and June 27, respectively. However, the FDA has committed to an action by May 15 for both NDAs. Based on the above, the Company is moving forward with full commercialization as planned. Here's one 15mg study in adult chronic insomniacs Message 21055550 Patients receiving indiplon gained approximately one hour of sleep over baseline. Safety results were consistent with those previously reported in other Phase III indiplon studies. Without reviewing other trial results, it would be unfair to judge this..however, one hour increase hardly seems adequate! I'll keep diggin'..good to be back talking medicines.. Elisabeth

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