FDA Decision Calendar: Some Potentially Prominent Decisions in Early 2009

Includes: BMY, IMCL, KG, PTIE
by: Mike Havrilla

The accompanying table (click to enlarge) presents a calendar of expected FDA regulatory approval decisions for 2009, including a March 1st deadline to expand the label of cancer drug Erbitux in what has now become a hostile takeover attempt by Bristol-Myers (NYSE:BMY) for the remaining 83% stake in ImClone Systems (IMCL) it does not already own.
Two other companies which are highly leveraged to their upcoming FDA decision include Pain Therapeutics (NASDAQ:PTIE) and King Pharma (KG) for Remoxy, which are due to hear back from the agency this year thanks to a priority review designation. Remoxy is an abuse-resistant form of oxycodone in a long-acting, oral formulation which was developed to deal with the diversion and abuse issues of OxyContin.
Disclosure: None