Anavex Life Sciences Corp (AVXL)

[TempePhil]

Steady and froll, this is from clinicaltrials.gov:

Estimated Enrollment : 21 participants
Intervention Model Description: 21 participants: 6 PK open-label followed by 15 double-blind, randomized, placebo-controlled

It sure sounds like the 6 PKs were included. Remember their safety trial was completed long before the full enrollment announcement, so they potentially had months for the drug washout, rather than the normal few weeks(IIRC).

Here are interesting questions...
If they were drug naive, then does that mean their efficacy values reverted to the safety trial baseline??? If yes, then the drug effect does not last?? If, no, then as you say, they are not drug naive, but how does that work in a blinded trial?

The safety test data shows 5mg daily(relatively low dose) as the daily dose, but the blinded trial shows the dose as 1 ml orally. I thought safety trials tried relatively high doses for tolerance, though the company calls them "relatively low dose". So this raises questions of concentration, etc.