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milehighbuck

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milehighbuck

Re: kipcher post# 276

Wednesday, 12/14/2011 12:29:08 PM

Wednesday, December 14, 2011 12:29:08 PM

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According to recent prs they are in the process of talking with one or more regulatory agencies ( pre BLA filing meetings with FDA, EMA, and Health Canada) and attempting to gain feedback on the next steps for submittal of the BLA. If the meetings go well we should see a BLA filing in late 1st half of 2012 or early 2nd half 2012.
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