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

To: keokalani'nui who wrote (774)	7/18/2001 8:59:50 AM
From: NeuroInvestment	Respond to of 1834

The response to my question (at least as I understood it )was: 1) The standard formulation compound Ph III will be completed mid-2003. The NDA for the standard formulation would be submitted at the end of 2003. 2) The modified release version is running 5-6 months behind but could catch up somewhat. They plan to submit a supplemental NDA (i.e. during 1H:2004). Gary Lyons said he hoped that the FDA would then act on the two submissions simulaneously, as a package. This--if were to occur, and one can certainly hope that there is a new FDA commissioner by that time, and a halt to the stalling tactics seen of late--could mean approval for both formulations by the end of 2004. Harry Tracy NeuroInvestment (www.neuroinvestment.com)