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Re: DewDiligence post# 156729

Monday, 02/11/2013 10:47:46 AM

Monday, February 11, 2013 10:47:46 AM

Post# of 257580

it’s reasonable to assume that the FDA will be less revealing of the methods used by ANDA applicants in light of the CAFC ruling in the Amphastar case.



I agree with your point about MNTA's trade secrets, but I'm not so convinced the FDA will be less revealing. If/when they approve m-copax it will be too quite some fanfare and I'd imagine the FDA will have to be equally as thorough (and revealing) in their reasoning as they were with enox.

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