InterMune Inc. (ITMN)

[someconcerns]

Would love to have some more stocks like ITMN!

http://www.minyanville.com/businessmarkets/articles/intermune-pirfenidone-lung-drug-ipf-idiopathic/12/17/2010/id/31764?camp=syndication&medium=portals&from=yahoo


"Shares of the company more than doubled on the news, trading at $33.09 midday Friday. Investors who stuck with this stock have been on a wild ride all year. The stock started the year at $13, shot up to $48 on expectation that the Food and Drug Administration would approve the treatment and then came crashing down to below $9 after the agency asked for another human trial to prove the drug was effective. An FDA advisory panel recommended approving the drug in March, which led investors to believe the product would be approved.

It’s unclear what InterMune’s next step is in the US. Another human study of the drug will be expensive. Welch says he’ll update investors early next year.

In the meantime, Welch is moving ahead with a planned launch in Europe and has even hired an overseas management team led by Giacomo Di Nepi, a former CEO of Takeda Pharmaceuticals’ European business.

Welch says he expects to hear from European Union officials by February or March on approval of Esbriet, which also is known by its chemical name pirfenidone. If approved, the drug will require some safety monitoring of patients, Welch says. He declined to discuss any details about potential labeling."