Anavex Life Sciences Corp (AVXL)

[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.