It seems some investors just don't seem to get the differences between the EU and U.S. approval process.
The European Medicines Agency's Committee for Medicinal Products for Human Use, or CHMP, is nothing like the Food and Drug Administration's advisory committee. About the only characteristic they have in common is that they both have "committee" in their name. CHMP makes "recommendations" to the EC the way advisory committees make recommendations to the FDA. But unlike advisory committee recommendations, which the FDA often disregards, the EC authorization is nothing more than a rubber stamp of the CHMP decision.
The EC's approval was therefore a non-event. It was expected right around this time, too, so I don't see how Cell Therapeutics is more valuable today than it was yesterday before the approval. The only drug I know of that didn't get an EC approval after a positive CHMP recommendation -- Johnson & Johnson's
It's not just Cell Therapeutics investors who seem to be discounting for no reason; InterMune
If investors are going to risk-adjust Cell Therapeutics for something, I'd suggest it be for potential sales in the EU. Pixuvri is approved for "multiply relapsed or refractory aggressive non-Hodgkin B-cell lymphomas." In laymen's terms, that means it'll be used after patients have failed other drugs such as Rituxan, which is co-owned by Biogen Idec
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