Replies to post #495926 on Anavex Life Sciences Corp (AVXL)

[crescentmotor]

The distinction between the subgroups wasn't known at the time the trial was designed.

The bashers on the board always want to take the discussion to the subgroups matter because of they believe the lack of pre-specification casts a shadow on the trial's results. It doesn't really affect Blarcamesine's chances for approval since the original data reported out of the 48 week trial passed the threshold for both sufficient safety and efficacy. As to the subgroups and the OLE data, that is extremely positive in that it adds additional confirmatory information to the blinded trial data that was already compelling.

[Hoskuld]

The "mutant type" does not seem to show 25% reduced progression - the mutant type seems to be barely impacted by 2-73. If 71.7% of the trial was wild type and that showed 49% reduction and the including the other 28.3% (mutant type) brings it down to 36% percent, then that math only works if there is less than 4% reduced progression on the smaller mutant type group.

And the trial was undersized. It should have been 50% larger. The company knows it, too. When I called to ask why the AD and Rett trials were undersized then they acknowledged it and said, "We didn't know it would work."

The bear case has merit, too. I am most definitely very long but it is clear that some serious mistakes have been made and we just have to hope the huge positives are enough to outweigh the mistakes that regulators often hold against companies and poorly managed programs. Missling has flown Anavex high and we have to hope not so close to the sun as to melt our wings.