Anavex Life Sciences Corp (AVXL)

[polarbear77]

dramnesia1, it seems you’re spending some time this evening (again) questioning and invalidating our efficacy signals and results to date. I’m not sure it takes a medical degree though to figure out if the Company is referencing positive response and efficacy in strong correlation with dose/concentration in its ph2a a2-73 participants.

I’m no doctor, but when Ariana and Anavex presented and concluded the below, what the #%@* type of response are they referring to? (if not various cognitive/function/biomarker measures as it relates to efficacy endpoints for AD patients)

I’ve provided the Ariana CEO’s conclusions and presentations below for your convenience.

If you’re short on time, skip to slide 25 in particular.

The below language is seemingly quite positive on its face, most would agree. I’m assuming then it’s just your personal decision to not believe Ariana and Anavex, correct?



[Below are quotes/cites from the October 2017 PK/PD presentation outlining Ariana’s & Anavex’s representations regarding dose/concentration relationships (from our 57 week ph2a AD participants):

http://www.anavex.com/my_uploads/ANAVEX2-73-PKPD-Phase-2a-2017.pdf

· Slide 3: in depth analysis using Ariana technology demonstrates “relationship between Anavex2-73 measured exposure and dose (PK) are consistent across study periods”

· Slide 3: in depth analysis using Ariana technology demonstrates “strong drug concentration / response relationship revealed for key Alzheimer’s disease trial endpoints cognition and function, MMSE and ADCS-ADL (PK/PD). This relationship is consistent across multiple time periods”

· Slide 3: “same applies for the brain activity biomarker ERP (PK/PD)”

· Slide 6: across the 5 weeks and the 52 weeks their slides say that the achieved (check mark) “dose-effect relationship”

· Slide 12: Ariana indicates “confirmed reliable inter-individual variability (dispersion) for the Anavex2-73 phase 2a study with 32 patient cohort” and that “this is confirmation that the sample of 32 patients of the Phase 2a provides reliable information regarding dispersion and as such allows for meaningful predictions for larger populations”

· Slide 13: Ariana indicates “relation between Anavex2-73 exposure and dose (PK) are consistent across administrations”

· Slide 14: “High Dose of Anavex2-73 correlates with exposure”

· Slide 19: “ERP Biomarker Shows Significant Drug Response: P3a Amplitude Increases with Anavex2-73”

· Slide 24: through Ariana’s KEM Systematic Analysis, they found 83 rules (possible relations across variables, endpoints, PK parameters and time) and “97% of them showing coherent dose-response relation”

· Slide 25: entitled “Robust Dose (Concentration) / Response Effect of Anavex2-73” and their KEM analysis provided “consistency for 6 main exploratory endpoints cognition, function and biomarker (MMSE, ADCS-ADL & EEG/ERPs) demonstrated through systemic exploration of the full data matrix”

· Slide 25: “97% consistency: MMSE, ADCS-ADL and EEG/ERPs: Identified relations show that high dose (concentration) is linked to improved response and low dose (concentration) to poor response”

· Slide 26: chart shows that for our participants that achieved >4ng/mL blood concentration level (9 total) during the 57 week study, that 4 improved on the MMSE tests and 1 remained at baseline (5 out of 9 is a majority)

· Slide 28: “an increase of MMSE is a rare event.” And “a patient receiving a higher concentration of Anavex2-73 has a +110% (2.1 fold) chance of improving its MMSE during 57 weeks”

· Slide 29: “KEM identifies strong non linear relations linking concentration with response for both MMSE and ADCS-ADL”

· Slide 30: High Anavex2-73 concentration linked to improved response consistently across all analytes and periods” and “both Anavex2-73 and metabolite show a consistent response across the 3 different time frames”

· Slide 32: “KEM analysis has identified exclusion / inclusion criteria. Each criteria has the potential to improve MMSE / ADAS-Cog for mild to moderate Alzheimer’s patients treated with Anavex2-73” and “these criteria will be incorporated into the upcoming Anavex2-73 phase 2/3 trial”]