Anavex Life Sciences Corp (AVXL)

[polarbear77]

You disparagingly accuse the Company of paralysis of analysis and accuse Dr M of purposely delaying the AD trial start??

I’ll try to outline the below as simply as I can for you.

Please explain to all of us how Anavex is supposed to PIONEER “the inclusion of advanced genomic biomarkers” in CNS precision medicine trials in 2018 under the NEW FDA guidelines released LAST WEEK without hiring Ariana & Illumina to perform pk/pd precision medicine & genomic sequencing analysis on our participants?

Is that even possible? Hello?

http://anavex.com/anavex-life-sciences-provides-clinical-programs-update-reports-fiscal-first-quarter-2018-financial-results/

“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. We are expecting to leverage these important findings to more precisely target patients based on specific genomic profiles that may be highly responsive to ANAVEX®2-73,” said Christopher U Missling, PhD, President and Chief Executive Officer of Anavex. “This should allow us to improve upon existing trial designs and expedite other aspects of our clinical development program.”

AGAIN I implore, have you been paying attention to our regulatory body’s shift into precision medicine for CNS diseases of significant unmet need? Paralleling the successes of oncology precision medicine trials in recent years. YES or NO?

If YES, then how EXACTLY would you recommend Anavex fit into these new 21st CCA precision medicine trial protocols (just released last week and recently alluded to in late January 2018 by the FDA) WITHOUT actually performing the Ariana/Illumina detailed analysis?

https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM596728.pdf

Page 13:
https://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Reports/UCM592001.pdf

If you’re being honest you’ll admit that there’s no way that Anavex could PIONEER these new precision medicine 21st CCA “inclusion of advanced genomic biomarkers” trials without successfully completing the Ariana/Illumina analysis recently AND without receiving the published guidelines from the FDA just LAST WEEK.

I’m assuming you would not advise that Anavex forgo these new innovative 2018 precision medicine CNS trial protocols and instead opt for the ineffective & inefficient trial structures of old? Correct???

Is any of this crossing your blood brain barrier?