From ST-Kettil2022
Something that may help
people understand what was
released and emphasized in the TLD.
The endpoint was originally stated as
"improved over baseline" and was
changed later to a "slowing of
decline". The responder analysis for
improvement was pre-specified in
the data analysis plan, which is a
formal part of the approved trial
design package, and is the
appropriate measure for assessing
'improved over baseline". 87% and
167% greater chance of improvement
on the 2 primary measures at p's<
.05 meets this endpoint clearly and
easily. The drug helps some patients
improve (more than just the placebo
based improvement). The
company's analysis plan included the
CDR-SB decline from baseline
analysis as the measure of
comparability to other trials like
lecanemab (which used this as their
primary endpoint). This analysis was
also significant and showed a clear
benefit of drug. It's unclear how much of the
additional analysis then had been
done Thur for CTAD or by the Mon am
CC. Missing said they didn't have
data on the change in any measure
over time, which does indicate how
much analysis, even by Mon am still
needed to be done ... just on the
behavioral data. There is
uncertainty, but there is lots of
analysis to come ... and the
explanation that Missing or the
company is shady is nonsense .. as
much nonsense as the reaction to the
Mon earnings CC that had people
claiming the data must be bad for
there to be Missing coy responses
about waiting til Thur for the data.
Bullish
