Not so fast. Their announcement doesn't mention the FDA denied them their attempt to skip Phase II and go directly to Phase III.
Remember, all prior press releases said the company was waiting to hear from the FDA on approval to start a Phase III trial.
It's better than nothing, but it pushes any US launch back a year.
Don't read too much into the spin. They aren't mentioning the FDA denied a Phase III start for 2010.
announcement by end of month?, page-13
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