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Post# of 252394
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Re: None

Tuesday, 01/14/2020 4:23:59 PM

Tuesday, January 14, 2020 4:23:59 PM

Post# of 252394
NKTR

In response to discussion question 2, the committees concluded that the data obtained from one pivotal clinical study are not substantial enough to support the proposed use.

In response to discussion question 3, more committee members were concerned with liver safety than were unconcerned.

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