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exwannabe

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exwannabe

Re: jbog post# 105121

Monday, 09/27/2010 8:13:05 AM

Monday, September 27, 2010 8:13:05 AM

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"Are they going to go to the FDA with this or just EMA? "

They have a SPA, so they are clearly submitting a BLA to the FDA. Timeframe is first half of '11.

It is the EMEA that is unclear.

There is also an open question of what happens if the ALCL trial comes in strongly positive. They could try and add that to indication in the same submission.
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