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Biotech / Medical : MGI Pharma MOGN New patents, anti cancer -- Ignore unavailable to you. Want to Upgrade?

To: sammaster who wrote (1656)	1/27/2006 3:28:03 AM
From: Icebrg	Read Replies (1) \| Respond to of 1826

I don't know. This was just something that popped up on one of my news scans. As the company writes: The Company affirms plans to submit a New Drug Application (NDA) for APF530 with the FDA under Section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act, if the pivotal trial of APF530 successfully meets its endpoints. my guess is that they are aiming for noninferiority status. 505 (b)(2) is a completely new ballgame. If the drug is approved based on this statute, competitors will be free to enter already after three years. More information on the 505 (b)(2) regulations can be found at findarticles.com Erik