Anavex Life Sciences Corp (AVXL)

[falconer66a]

In drug development, observations don’t count.

If our drug does very well in subset of patients shouldnt it be obvious to clinicians? And dont remarkable fin[din]gs warrant early intervention by fda before trial termination?

Nope. Big problems with this. Observations of new, unexpected therapeutic results, no matter how desired they might be, are utterly dismissed. Absolutely no attention is paid to them, because they are merely “observational.” They are merely new, unexpected things that were seen. Seeing, in drug development, is not believing. Not allowed. It’s always regarded as one of only two things. Unexpected, untested-for new results are either placebo effects (things caused by mental expectations, not actual biochemical drug mechanisms); or, simply inaccurate perceptions of what was “seen.” Placebo effect or observational error. Nothing else is allowed to explain unexpected, new good results.

If enough of those appear, they can suggest that a new, well-defined clinical trial specifically testing for what was “seen” should be conducted. But, under no circumstances can those new, unexplained observations validate any direct, consequential new therapy. NOTHING in drug development is accepted, presumed to be scientifically and therapeutically valid until it is statistically confirmed by a properly blinded clinical trial, with valid biostatistics.

All of this is likely to involve blarcamesine, when (as previously has been the case) it is “observed” that the drug produces sound, healthful sleep, especially in those with CNS diseases that inhibit healthful sleep. Observationally, blarcamesine has great potential as an insomnia remedy; solving the many problems caused by poor sleep pathologies. But it’ll take a big clinical trial to validate this.