Anavex Life Sciences Corp (AVXL)

[nidan7500]

bas2020

t would be a true disappointment and failure if the endpoints missed an expectedly "normal" placebo response of little to no improvement. If the placebo response was "normal", blarcamesine would've clearly exceeded in meeting endpoints and the trial would've been a resounding success.

Obviously, that didn't happen. Instead, the trial got hit with some unfortunate bad luck with extraordinary placebo scores. However, it's not the first time a Rett trial has experienced this... and the reasons behind it are quite plausible. It's not a true placebo effect with the patient, where the patient realizes s/he is taking a drug and believes it's helping him/her. Rather, it's one that's expressed and influenced by the parents/caregiver... and that positive "hope" and belief are conveyed to other Rett parents, as well as the reviewers. It's rather normal for this "bias" to happen... more so with pediatric patients than with aging AD patients.

It's not the first time the FDA has experienced this phenomena... and is why they frequently approve a drug in these circumstances, especially a safe drug. They review the entire package of trial data, OLE and REW information in the approval process... not just the p-values.

Not concerned at all about the prospects of approval for Rett... and AD.

Great-refreshing-evaluation and post...thanks, we needed that assurance. Let's face it...this is very thin ICE w/many worried onlookers. The criteria of not getting (even a little bit) wet is a worry. Thanks for the value added reasoning.