Sunday, December 04, 2016 10:23:15 AM
So did I. The July poster said the results from the monotherapy "stratification" (ie, sub group) isn't able to be statistically validated. I think that's one of the reasons they hired Ariana, to do more robust analytics. So Missling is being conservative in saying there no differentiation between combination and monotherapy: we don't have a statistically valid conclusion on that yet. And add in the fact that those monotherapy patients are also likely the most mildly impaired (MCI). Until you can clinically and statistically tease out which of those two correlated independent variables (monotherapy and cognition stage) is the valid one (and perhaps they are both valid, or neither) then he has to be conservative for the sake of clinical soundness.
I am hoping that with Ariana's help and 52 weeks of data, we're going to see a 180 on the monotherapy. That is, Missling is going to eventually say that 2-73 works better without DZP. Or he says 2-73 appears to be working best with the least impaired patients. Or both of these. The problem with the MCI patient subgroup is that early AD misdiagnosis is not uncommon, which would render the latter conclusion from such a small sub group unreliable really.
Bottom line, I think Missling has been burned on the earlier 2-73 synergy claim and is now being conservative. In my opinion that's not a bad thing. Perhaps with the upcoming longer term data releases, and Ariana's help, he'll have more confidence to promote the sub group results.
I am hoping that with Ariana's help and 52 weeks of data, we're going to see a 180 on the monotherapy. That is, Missling is going to eventually say that 2-73 works better without DZP. Or he says 2-73 appears to be working best with the least impaired patients. Or both of these. The problem with the MCI patient subgroup is that early AD misdiagnosis is not uncommon, which would render the latter conclusion from such a small sub group unreliable really.
Bottom line, I think Missling has been burned on the earlier 2-73 synergy claim and is now being conservative. In my opinion that's not a bad thing. Perhaps with the upcoming longer term data releases, and Ariana's help, he'll have more confidence to promote the sub group results.
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