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Re: nidan7500 post# 106409

Sunday, 05/28/2017 1:22:52 PM

Sunday, May 28, 2017 1:22:52 PM

Post# of 459875
And Fadiran will help with the first 3 items:

holding meetings with the sponsor and the review team throughout the development of the drug

providing timely advice to, and interactive communication with, the sponsor regarding the development of the drug to ensure that the development program to gather the nonclinical and clinical data necessary for approval is as efficient as practicable

taking steps to ensure that the design of the clinical trials is as efficient as practicable, when scientifically appropriate, such as by minimizing the number of patients exposed to a potentially less efficacious treatment
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