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Replies to #12908 on FDA Plays
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DewDiligence

02/25/11 1:03 PM

#12909 RE: oldberkeley #12908

PLX—The comment that stuck in my mind was, “We do not have a clear answer why these points were not raised earlier in the process.”

The same question can be asked of PLX management insofar as it’s management’s job to anticipate problems in the FDA review and address them prophylactically.