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Re: mcbio post# 88199

Tuesday, 08/30/2016 5:13:49 PM

Tuesday, August 30, 2016 5:13:49 PM

Post# of 251718
MDCO -10%/AH on unexceptional interim analysis in MILANO-PILOT study of Apo-A1-Milano:

http://finance.yahoo.com/news/medicines-company-provides-dyslipidemia-programs-203000383.html

A planned, interim analysis of the first 40 randomized patients completing treatment in the MILANO-PILOT study of MDCO-216 has been reviewed by the Independent Data Monitoring Committee (IDM Committee). Based on the protocol and pre-defined criteria in its Charter, the IDM Committee has reported the 40-patient data to the Company in summary form and recommended that the MILANO-PILOT study continue. ]b\The pre-defined, upper statistical boundary for efficacy, which permits early termination of the study by the Company, was not met and, given the limited number of patients included in the first interim analysis, the summary data received by the Company from the IDM Committee are, at this time, inconclusive.

The Company has completed enrollment of the planned 120 patients and expects that results from the MILANO-PILOT study will be presented by its principal investigator, Dr. Steven Nissen of the Cleveland Clinic, in the Late-Breaking Clinical Trial Session at the American Heart Association (AHA) Scientific Sessions 2016 on November 15, 2016 in New Orleans.

The PR says that interim data from the PCSK9 ORION-1 trial will be presented at the same conference.

p.s. A perusal of this thread will show just how slow the clinical development of APo-A-1-Milano has been.

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