Anavex Life Sciences Corp (AVXL)

[Investor2014]

Anavex have so far run all too small n and too short trials both in Rett & AD with designs that have provided unreliable, but indicative results that A2-73 may well have merit. All of them with long running OLE and compassionate use access to A2-73, which is likely a positive but won't take the place of hard controlled trial outcomes (despite a KOL having apparently told Missling so).

The U.S. adult Rett trial was so small that it could not have provided any other but false input to the design of the EXCELLENCE trial. The AVATAR trial was also too small, too short and with too few sample points. Then at last moment using a nonsensical AUC outcome measure, most likely done because the placebo response was so high that the trial otherwise would have shown a clear fail.

The EXCELLENCE trial was not only too small and too short, but also designed with 2:1 drug/placebo arms, which it seems amplified what Anavex should already have learned - that is a high placebo response is likely especially in a short Rett trial with subjective scoring outcome measures. Anavex did not learn or were unwilling or unable to execute a well-designed trial.

Now finally Anavex will likely be forced to run an appropriately designed Rett trial, unless by some regulatory miracle their already planned next Rett trial ends up being unnecessary.

We are also eagerly awaiting another potential regulatory miracle in Europe from the P2b/3 AD trial, which has a non-zero chance of approval (<50% imo others feel even less).

The modus operandi of Missling is penny-wise and pound-foolish!