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

To: Icebrg who wrote (1153)	7/24/2003 7:00:28 AM
From: Icebrg	Read Replies (2) \| Respond to of 1834

Date for Indiplon IND filing. I wonder if they just slipped a couple of months. From today's Q2-report: The Company is also working with the Food and Drug Administration to schedule a pre-NDA meeting in 3rd quarter and anticipates filing an NDA for indiplon in the first half of 2004. They used to say (for example in the Q1-report): We remain on track to file our New Drug Application (NDA) for indiplon in early 2004 There should be a reason why "early 2004" now has become "first half of 2004". Perhaps the reason is that Pfizer and Neurocrine have decided to put even more data into the submission packet. In addition, Pfizer and Neurocrine have recently increased the indiplon development program budget to optimize the NDA submission. A portion of this will be paid by Neurocrine during 2003 and 2004. The clinical trial endpoints have not been changed or modified nor have any interim analyses been performed. Erik