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Re: novicetrader post# 113

Wednesday, 12/02/2015 12:41:25 PM

Wednesday, December 02, 2015 12:41:25 PM

Post# of 335
I haven't followed as closely as I should,

but they closed that portion of the trial, however there was nothing indicated that patient was anticoagulated at that point.

"After review of its ongoing clinical trials, the Company has elected to proceed with efficacy and safety data analysis and close the randomized portion of its Phase 3 ZAF-311 clinical trial of beloranib in patients with Prader-Willi syndrome (PWS) and its ZAF-203 Phase 2b clinical trial of beloranib in patients with severe obesity complicated by type 2 diabetes. Zafgen believes that a sufficient number of patients have completed randomized treatment in both clinical trials to assess the efficacy of beloranib and help inform next steps for the beloranib program. Following the partial clinical hold announced last week, the Company believes it can best preserve the integrity of the data in each clinical trial by closing the randomized portion of the clinical trials early. The Company, based on consultation with the U.S. Food and Drug Administration (FDA), expects ZAF-311 to remain a pivotal clinical trial. The Company expects to report top-line results from both the ZAF-311 and ZAF-203 clinical trials in the first quarter of 2016."

Zafgen Announces Beloranib Program Update - Yahoo Finance
http://finance.yahoo.com/news/zafgen-announces-beloranib-program-103000257.html

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