Replies to post #93917 on Biotech Values

[DewDiligence]

Thanks, floblu. The M118 write-up from TCTMD has some good info, including the easy to read tables for the EMINENCE efficacy and safety data. Regards, Dew

[alertmeipp]

MNTA: unfortunately, at this point.. the only thing that matters is when the FDA will make its call.

They were expecting last year end - we are in mid April now.

So I expect it really will comes anytime now.

[DewDiligence]

M118 EMINENCE Study Met Prespecified NI Threshold



The above table from the paper in the Apr 2010 issue of Circulation
(#msg-48705801) shows the prespecified non-inferiority analysis.

The criterion for a finding of non-inferiority was that the upper bound
of the 90% confidence interval on the primary endpoint delta of M118
relative to unfractionated heparin (UFH) was less than 0.08 (i.e. 8.0
percentage points). This criterion was met by each individual
M118 arm and by the composite of the three M118 arms.