Anavex Life Sciences Corp (AVXL)

[Hoskuld]

Sab, did you see Jesse Brodkin ask the first question at the Dec presentation? He is a short tool. The biotech world has zero problem with the way the data was presented. It does have a problem with the way it is mischaracterized by shorts (and the way that mischaracterization is echoed by others.)

What was presented then, and what has been presented since, is amazingly well organized and successful data and analysis. They hit all their endpoints (described in the SAP) and now have the biomarker data (including incredibly good brain volume data and the beta amyloid data that the FDA already has a history of weighting for AA approval.) What doesn't Sab like? You don't like that doc and 2014 and georgesk want information that was not part of the approved SAP?

Do you see the problem here? You claim you are not an expert but now apparently think you know more about statistics and regulatory filings and regulatory likelihoods of approval than Anavex or the FDA itself. A remarkable shift in attitude.

I actually do know something about these things. The AA pathway has been used successfully before for AD drugs that have less efficacy and (possibly more importantly) much, much worse safety profiles. Does that mean 2-73 will be approved using the AA pathway? Probably, but I can't be as sure as you are that it won't. Does the FDA want information that clinical data and analysis were not prospectively designed to present? Maybe, but probably not.

The FDA is very professional. I liken it to a court: people who watch the news have sensational opinions about trials, but jurors follow the judge's instructions rigorously. Here, you and your friends "doc" and "2014" like to sensationalize it up - pretend your opinions matter. But, the FDA will follow its guidelines and almost certainly approve. Can things go wrong? Sure. Some trials go sideways and some FDA decisions go sideways. But history and guidelines say 2-73 will be approved for AD.

On a personal note, I have to admit I was taken in by you for a few months. No more.