) to buy.
Analyst Mike King says in a surprising decision, an FDA panel overruled the FDA's statisticians and medical reviewers to vote 11-3 in favor of accelerated approval of AstraZeneca's lung cancer drug Iressa.
King says the panel made recommendations that include a trial, one that is designed similar to OSI Pharmaceutical and Genetech's Phase III trial for their lung cancer drug Tarveca. He says the panel's decision significantly reduces the regulatory risk for OSI's Tarceva.
King raised his fiscal 2004 to 2007 (Sept.) Tarceva sales estimates to $50 million, $172 million, $379 million and $610 million, respectively, and raised his fiscal 2003 to 2007 earnings per share estimates. Given that the stock is trading at a fully distributed market cap of $750 million, King says shares appear to offer substantial upside. He set a $23 target.