You said:
"What you need to remember is that the current Anavex 2-73 trial is only a Ph 2a trial. A primary endpoint to the trial, which I believe is typical for most Ph 2a trials, is placing patients on different dosages to find out what the maximum tolerated dose is for patients that have different characteristics. For instance, maybe the trial will discover that the mild Alzheimers patients could tolerate a higher dose whereas the moderate patients could only tolerate a lower dose. Patients that dropped out due to dizziness etc..........probably were on too high a dose, given their particular circumstances. "
I haven't forgotten at all that Anavex is only running an unblinded, non-placebo controlled, underpowered Phase 2a trial with only this primary endpoint.
"Primary Outcome Measures:
To determine maximum tolerated dose of Anavex2-73. [ Time Frame: 36 Days ]"
Now, to me, if a CEO says that he designed this trial to "fail quickly" I am left dumbfounded.
How about this idea? Run your phase 2a dose finding trial to "succeed quickly" then run a real life big boy pants double blinded, placebo controlled, properly powered 2b trial with a primary endpoint of efficacy designed to "fail quickly".
Let's ignore for a second that the results Anavex has produced to date come only from a trial design that is fraught with the opportunity for bias to be introduced because its unblinded. Here is an example of why a graph with the label "all patients" , like Anavex is using, with no further description is disingenuous and possibly misleading imho.
" the primary endpoint was met in 46% (Per Protocol) and 40% (Intent-to-Treat) of patients who received 200 mg of Prurisol per day. These data were derived from analyses of all patients.
See how you need more information to evaluate Anavex's graphs beyond the label of "all patients"? Do you believe management does not understand this concept or is intentional presenting questionable data?
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