Anavex Life Sciences Corp (AVXL)

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Could it have been bad clinical design, or cherry-picked data?

Kid2 intelligently asked, “Could it possibly be due to a flawed trial design? Could it possibly be due to biased data collection? Could it possibly be due to ambiguous data presentation?”

A understanding of the answers to these cogent questions should bring clarity as to why I and so many other retail AVXL shareholders are certain of Anavex’s successful future.

Were the profoundly successful clinical results of the trial because of bad clinical trial design? Did Anavex construct the trial so that only positive results might emerge, making the drug “look good,” when, in fact, actual patient experiences were not as presented?

This would be an allegation of profound fraud, for which the Securities and Exchange Commission would take great offense. It’s both academic and fiducial fraud.

And, it did not occur. The presented trial results are true and accurate.

Examine the upper plot on p 29 of the CTAD presentation (http://www.anavex.com/wp-content/uploads/CTAD-Anavex-December-2016-2.pdf).

This a plot of the MMSE (Mini–Mental State Examination) scores. The MMSE score is a widely-used, professionally-accepted determination of cognitive impairment in neurodegenertive diseases, particularly Alzheimer’s. The questionnaire (not generated by Anavex) is here: http://www.heartinstitutehd.com/Misc/Forms/MMSE.1276128605.pdf

The instrument to determine the state and progression of cognitive impairment during the Anavex2-73 clinical trial was as accurate and precise as possible in modern psychology.

The trial was conducted by PhDs and MDs whose professional careers rest upon use of accepted and replicable clinical methodologies. The presentation was vetted and pre-accepted for presentation at the 10th Clinical Trials on Alzheimer's Disease (CTAD) conference, conducted by world-class Alzheimer’s researchers and clinicians. As in similar scientific conferences, statistically or methodologically questionable data are simply not allowed to appear. The accuracy and applicability of the Anavex data were thoroughly vetted. CTAD is no eighth-grade science fair with sketched data on some cardboard displays.

Were the data “ambiguous?” No. They were very precise, within very narrow range bands. Someone asked how I could be certain that every single trial participant demonstrated symptomatic stabilization or improvement. Again, look at the plots on p 29. Notice the black vertical lines and bars at each data point. They indicate the range of all of the assessed scores at that timepoint. Had there been a few whose symptoms did not stabilize, whose cognition scores continued to worsen (the case in all other Alzheimer’s drug studies longer than three months), the range bars toward the end of the study, on the right would have been long, descending sharply downward, away from the yellow mean score line.

For those who know how clinical trials are conducted, and how to interpret plotted clinical results, the CTAD Anavex data couldn’t have been more positive. Anavex2-73, when administered over a year to those with mid to mild stage Alzheimer’s, will either terminate symptomatic worsening, or even reduce it. This happened in all clinical trial patients, without exception. As presented before (post 86140) the chances of these results occurring by fortuitous happenstance, not actual drug efficacy, are nil.