Press Release Source: Biodel Inc. On Wednesday September 1, 2010, 7:00 am DANBURY, Conn., Sept. 1 /PRNewswire-FirstCall/ -- Biodel Inc. (Nasdaq:BIOD - News) announced today that Linjeta™ (pronounced lin-JET-uh) will replace VIAject as the proposed trade name for Biodel's most advanced product candidate. The change follows FDA's review and acceptance of Linjeta™ as an alternative name for Biodel's more-rapid-acting insulin formulation that is currently under review by the U.S. Food and Drug Administration with a Prescription Drug User Fee Application date of October 30, 2010.
Dr. Errol De Souza, Biodel 's president and chief executive officer, stated: "Today's news reflects the continued progress of the Linjeta™ new drug application through FDA review and is an important milestone in our effort to commercialize this new drug candidate."
Actually it does mean a lot. The trade name is something that is later in the FDA NDA process. A lot of applications never get that far b/c the FDA gets held up on an earlier part of the application. They just don't bother with this part if they think they are far away from approval (like making them do another trial). So I think this news is more positive then most people realize. I think this improves the chances of first pass approval.