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InTheTrenches

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InTheTrenches

Re: crimsonreign post# 16672

Friday, 07/15/2016 8:24:56 PM

Friday, July 15, 2016 8:24:56 PM

Post# of 38634
I, too, wish they would act more quickly, but I don't expect they will. Cancer drugs for dying patients can expect their review to require the full allotted time, which is why the priority designation is so important. This cuts the review cycle time from 12 months to 8 months.

NDA paperwork can be thousands of pages of documents, and require review by several individuals in different disciplines (biochemistry, statistics, manufacturing, etc).

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