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Post# of 59549
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chevyman

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chevyman

Re: Dr. Mugs post# 46654

Sunday, 08/28/2011 9:09:17 PM

Sunday, August 28, 2011 9:09:17 PM

Post# of 59549
Dr. Mugs, I suggest one should research an NSE decision letter at length...NSE means" NOT substantially equivalent". It's not a DNW "does not work" letter! The application had reached it's third review cycle without enough data for the FDA to make an SE decision, which results in NSE. This is all available on the FDA website!
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