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LongRun8

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LongRun8

Re: diannedawn post# 354

Thursday, 12/19/2013 10:39:05 AM

Thursday, December 19, 2013 10:39:05 AM

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The 180 degree turn-around seems very unlike the FDA. Glad they are doing an about-face, though! The FDA does seem much harder to get a drug passed through than in Europe...and I agree, they don't really seem to care if Europe uses it or not. But in this case, at least they will allow patient and physician experience with the drug to serve as a response to the CRL.

Happy holidays to you as well.
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