Anavex Life Sciences Corp (AVXL)

[tradeherpete]

Last week we saw the announced formation of the AVXL (Merck, Sage, other) consortium with a focus on Biomarkers and ERP-AI through a company (Cognision). AVXL has already earlier published an ERP_AI patent for the outpatient use of ERP as a treatment process for AD patients. We also note that Cognision has been granted FDA validation and 510K(K141316) for use as an ERP device in such practices. The patent/partnering w/Cognision presents a non trivial step to Biomarker development in the application of ERP and AI.

So what's next? Consistent with the news released on the 29th by the FDA I would anticipate that future p3 approval trials will be more focused on specific Biomarker endpoint. (eg PDD not only movement but corresponding ERP data). Eventually trials will become much shorter, only long enough to verify that the required patient medical end point is met and the corresponding ERP data have been achieved. This kind of process should lead to EA releases under controlled conditions with patients who are in such a position to move on w/their lives as an outpatient. The days of the , " One size fits all" trials are ending. The technology will evolve over time as AD Dementia holding pens get emptied./quote]

-Brilliant Nidan.

Finding out Actigraph is being used in the PDD trial, we could look forward to learning how much that can tell us regarding patient improvement. It might be eye opening. Will the Rett trial be taking advantage as well since it is also a movement disorder? Again, strides are being made increasing the amount of information that can be gleaned from a well designed trial. Did Neuron use Actigraph? This kind of biometric device might see use in all future drug trials as the body and mind are linked in patients that are sometimes not able to verbalize or even be aware of what’s happening to them.

Are we seeing the tip of the iceberg moving forward in drug trials? Let’s hope so.

imo