Anavex Life Sciences Corp (AVXL)

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Will There Be Clinical Information Restraints?

Everyone looks for the earliest clinical results from any of the three upcoming studies of Anavex 2-73 in humans, whether in little girls with Rett syndrome, or older people with Parkinson’s or Alzheimer’s diseases. Will be hard to contest or dismiss those results, whether positive or negative. Clinical results will be the definitive thing for Anavex.

For Anavex investors, the most difficult situation will be if any sort of intermediate, on-going clinical results are never disclosed or leaked; that everyone must wait for the formal end of the studies and the subsequent appearances of their technical results.

I ask, then, will those conducting the three trials configure things so as to somehow keep intermediate results in-house and undisclosed before the trials formally end?

Will trial participants and their families and doctors have to sign non-disclosure agreements (NDAs), agreeing to keep their perspectives and thoughts silent until formal results are published? Might continuance in the trial be subject to such non-disclosure?

I’ve suggested previously that it might be difficult to keep a tending nurse or mother of a Rett syndrome girl in the study from inadvertently telling friends or family members about a Rett girl who, after taking the drug, has clear symptomatic improvements of any number of frank (visible) symptoms.

What if, say, 90 of the 300 Alzheimer’s patients taking the drug in the Australian trial simply regain their cognitive functions, sleep well, and clearly progress positively? How, or would those results remain hidden for the remaining weeks or months of the trial?

I’d love to learn how the medical (and legal?) people conducting the trials will attempt to restrain preliminary releases of individual clinical results — if they will or can.