Anavex Life Sciences Corp (AVXL)

[F1ash]

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"1. What are your thoughts on the strong 6 responders?
2. Do any Alz drug trials see such cohorts sustain outperformance (into 57 weeks) beyond initial phases of testing that may be placebo effect related?
3. Have any Alz drug trials exhibited an upturn in MMSE or ADCS-ADL for the entire study group, not just for a cohort.
4. While MMSE is the most reliable measure acknowledged by peers, is it fair to say it FULLY/COMPREHENSIVELY captures and reflects changes & progression and therefore qualitative reporting of benefits is redundant and shouldn't be considered by the FDA? "
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#1.... Consider reading this study.

"Variability in Annual Mini-Mental State Examination Score in Patients With Probable Alzheimer Disease"

http://jamanetwork.com/journals/jamaneurology/fullarticle/775209


#2....The attached graph shows dots that represent the changes in test scores. Notice how many participants actually showed an increase even after 3 years. (It's "Figure 3" if the first link does not work)

http://jamanetwork.com/data/Journals/NEUR/6482/noc8161f3.png

http://jamanetwork.com/journals/jamaneurology/fullarticle/775209

#3.... When you say "The entire study group" do you mean the 25 who are left or the 32 who started the trial? No one seems to know or even care how those individuals are represented in the graphs. How that data is represented in the graph could make significant changes in its interpretation. Traditional dropout rates in the placebo arms of Alzheimer's trials are.....
"•In RCTs for Alzheimer's disease one out of fifteen patients treated with placebo drops out because of AEs." ,

but here 5 patients dropped out so that's double the expected rate. Why did they drop out?

http://www.jns-journal.com/article/S0022-510X(15)00311-1/abstract

#4...."Conclusions Although the Mini-Mental State Examination is a useful screening instrument to assess level of cognitive function, it has limited value in measuring the progression of Alzheimer disease in individual patients for periods less than 3 years because of a large measurement error and substantial variation in change in annual score"



What are your thoughts after reading the studies I referenced?