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sts66

03/16/14 12:51 PM

#26031 RE: johnking29 #26026

FDA rules say they have 180 days to reply to a CP, but as we all saw with the BS Lovaza CP they can say "this is too hard to figure out, we need more time, so we'll reply when we feel like it" - and AFAIK there is no legal way to force them to adhere to the 180 day rule.