Anavex Life Sciences Corp (AVXL)

[BakedLangostino]

It didn't miss. Think of it like an NFL kicker about to take a kick and it drinks off the goal line, but there was a defensive penalty so there's going to be a re-kick from slightly further back. Happens all the time. The question is if this study had the same patient population as the Daybue trial, would it have achieved statistical significance? By all accounts it was underpowered and therefore a crap randomization adversely clouded an otherwise positive trial.

Will the FDA see it that way, look at the favorable safety profile and fact it doesn't require caretakers to clean up diaper messes, and take into account the personal testimonies of families that Blarcamesine ultimately improved quality of life in ways that are clearly not placebo -- whether it be improved sleep or reduction in seizures? Or is the FDA content on letting Daybue be the placeholder until gene therapy or something else comes along?

I think ultimately the Rett community looks at how Sarepta got its drug approves and follows a similar course. I think the totality of the situation warrants at least another trial, this time powered to reduce the odds that a crap randomization repeats itself, and the outcome becomes much clearer.

I remember building puzzles with my kids and we'd be missing a few pieces. The incomplete puzzle would sit on the table for a few days. Sometimes we'd find those pieces, sometimes not. Another trial should produce the full picture -- a good one -- in due time. I don't know if many here have the patience and my fear is that this time, the shareholder lawsuits will grow stronger legs. Not strong enough to take flight but at least get down the runway.