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genisi

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genisi

Re: DewDiligence post# 118049

Monday, 04/11/2011 2:26:37 PM

Monday, April 11, 2011 2:26:37 PM

Post# of 252272
Approval of the “import” route also known as a Class 3, requires a PK/PD study to prove bioequivalence and a single phase III confirmatory trial, both in Chinese patients. The problem usually isn't the trials but the inefficiencies of the SFDA with relatively long review process and then not many clinical sites. It's improving though.

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