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Biotech / Medical : Biotech Short Candidates -- Ignore unavailable to you. Want to Upgrade?

To: tuck who wrote (731)	12/21/2004 8:00:21 AM
From: rkrw	Respond to of 897

I'd feel bad for talking you out of it, but you forgot to mention formatting risks :-) My main concern about the sleep market is cialis/viagra/levitra marketing wars yet a risk of low overall category growth-low profits for all. I think nbix taking 30% straight royalties (vs profit share-loss sharing :-)) was shrewd. Press Release Source: Neurocrine Biosciences indiplon IR NDA (New Drug Application) to Be Reformatted Due to Difficulties in Accessing Portions of the Electronic NDA Tuesday December 21, 7:01 am ET SAN DIEGO, Dec. 21 /PRNewswire-FirstCall/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX - News) announced today that the U.S. Food and Drug Administration (FDA) has not accepted the Company's NDA for indiplon immediate release (IR) due to difficulties encountered in navigating the electronic NDA. Neurocrine is working to resolve the issues relating to the navigation of the electronic filing and to minimize any impact on the expected timelines for approval and launch of indiplon. The indiplon modified release (MR) filing is currently under review with the FDA and the Company is also working to address any potential formatting issues with the MR filing. The formatting issues are based solely on technical difficulties with the electronic navigation and do not pertain to the content of the filings. ADVERTISEMENT The IR NDA was submitted on October 19, 2004 to the Anesthesia and Critical Care Division of the FDA and was transferred for review to the Neuropharm Division of the FDA on November 19, 2004. The Neuropharm Division is now responsible for the indiplon review and approval process. The filing contains studies which comprise one of the most extensive programs conducted to date in insomnia, with data from 68 clinical trials and over 80 preclinical studies. The NDA was filed in eCTD electronic format, which contains over 1,350 volumes or 475,000 pages of data.