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Re: DewDiligence post# 195536

Friday, 10/02/2015 10:05:18 AM

Friday, October 02, 2015 10:05:18 AM

Post# of 252186
CHRS—More details on the questionable Neulasta-FoB bioequivalence study are in the company’s 8-K filing:

http://www.sec.gov/Archives/edgar/data/1512762/000119312515335439/d71768dex991.htm

A low, anomalous PK profile in the Period 1 Neulasta group resulted in not meeting bioequivalence in the area-under-the-curve (AUC) endpoints (AUC 0-to-288, AUC 0-to-Infinity, AUC Last). This anomalous result is being investigated.

See the actual curves at the above link.

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