The accompanying table 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 (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 (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.
$9.84 (09/24/08)
