Thursday, October 12, 2017 2:45:57 PM
Patients dropped out due to:
Consent withdrawn or lost to f/u = 4
Delirium or confusion = 2
Dizziness = 1
If you take the safety and low AE profile you all seem to attribute to 2-73 (possibly excepting Cadno) then only dizziness was likely to be drug related and was only grade 1. This suggests a high blood concentration and what should be the most treated and best performing (if you believe what was said this morning) but there was not enough motivation to continue in the face of minor dizziness.
The consent withdrawn and lost to f/u patients also likely represent lack of motivation...no perception of benefit (by the patient or family) to bother continuing...i.e. worst performing.
Those with delirium/confusion are having evidence of persistent/progressive AD. This may be triggered by outside factors (e.g. UTI) but nothing to suggest they were doing well.
The early delirium patient drop out was likely the flip side of the "super responder" that seemed to have all their improvement in the first 5 weeks. One was likely resolving delirium while the other was evolving delirium...but only then one that pads the numbers gets entered.
As for timing, 5 patients that eventually dropped out later entered the 6 month extension including 2 that completed 6 months. Despite this we only seem to see data for one of those 5. Any that got to the ~17 week point should have data. At least one more was excluded that made it to the 6 month eval. Where is AVXL's explanation of this absence. Are they once again cherry picking only the data they wish to include? The unnecessary and unexplained absence of data casts doubt on all their prior reports.
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