Replies to post #140089 on Anavex Life Sciences Corp (AVXL)

[nidan7500]

“This should allow us to improve upon existing trial designs and expedite other aspects of our clinical development program.” '

Agree also. If this will all happen in my lifetime is an unknown but AVXL is clearly looking to only use trials as a method for verification of the upfront analysis proving it was completely and properly done. A massive learning process shift from old days which, we can all see now, was massively expensive and marginally effective. When he finally proves this technique is effective (as it must be) we will all be better off. Have to work on the timing thing.

[polarbear77]

Agree completely, great points Sokol/Nidan. Our approach does dovetail nicely with Dr Gottlieb’s comments at Davos.

I’d argue that the months of trial initiation “delays” related to BOTH:

• Precision medicine data analysis: as Dr M stated today “We believe Anavex is pioneering the inclusion of advanced genomic biomarkers into late-stage CNS precision medicine trials, including our Rett syndrome, Alzheimer’s disease and Parkinson’s disease trials. It was a strategic decision to start the new clinical trials after genetic data were collected and analyzed.”

AND,

• Awaiting the new 2018 FDA Strategic Policy Roadmap with 21st CCA precision medicine trial designs & protocols from our regulators (streamlined orphan designation review, accelerated approval potential and use of RWE and patient perspectives with this new 2018 framework).

[January 2018 FDA release titled: HEALTHY INNOVATION, SAFER FAMILIES: FDA’S 2018 STRATEGIC POLICY ROADMAP
https://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Reports/UCM592001.pdf ]

I’ll take waiting a few months to file INDs so as to be modeled with the first precision medicine CNS trials/frameworks under the new 21st CCA legislation.

To think that Anavex could effectively PIONEER “the inclusion of advanced genomic biomarkers into late-stage CNS precision medicine trials, including our Rett syndrome, Alzheimer’s disease and Parkinson’s disease trials” without BOTH of the above accomplishments/releases would be absurd.

Would’ve been nice to start Rett trial last Summer/Fall, however they must have their reasons.

Meanwhile, Anavex (not BP) will be pioneering these precision medicine aspects in CNS trials? I believe I read that correctly.