My understanding is that ODS, if it is granted should be received after the commencement of the phase IIb trial, and hopefully not to long after patient treatment begins.
I also believe they may try for a US FDA meeting to have the phase III trials in Europe conducted under US FDA amd EMEA regulations so they don't have to conduct further phase III trials with the US FDA.
Good luck to all.
dc
provenge a 65/35 chance of approval, page-21
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