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Re: jbog post# 116383

Sunday, 03/13/2011 9:15:37 PM

Sunday, March 13, 2011 9:15:37 PM

Post# of 252337

I don't understand your 2nd point that the FDA doesn't have as much leverage in the manufacturing process. You might want to ask JNJ about that.



Consent decree is extreme measure FDA doesn't use that often. FDA has to go through court and negotiate with the company to finalize consent decree. Look what JNJ had to do in the last two years to get consent decree.

As of FDA leverage, in Teva's case, what is FDA's leverage? Not much beyond the threat of holding further approval. Teva isn't going to get a consent decree because that bar is very high.

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