Replies to post #180759 on Anavex Life Sciences Corp (AVXL)

[georgejjl]

The ANAVEX 2-73 trials are proceeding as planned

ANAVEX®2-73 Program Update:

Since enrollment started on October 30, 2018 for the Phase 2 ANAVEX®2-73 Parkinson’s disease dementia (PDD) study[1], over one-third of the total patient enrollment target has been achieved to date.

Enrollment for the Phase 2b/3 ANAVEX®2-73 Alzheimer’s disease (AD) study[2] is proceeding as planned with over 80 patients screened to date.

Successfully submitted Phase 2 ANAVEX®2-73 Rett syndrome (RTT) study[3] to respective United States Institutional Review Boards (IRB) of the first three clinical trial sites.

https://www.anavex.com/anavex-life-sciences-reports-fiscal-2019-first-quarter-financial-results-and-provides-clinical-study-updates/

Good luck and GOD bless,

[BAR123]

George where did you get the updated pipeline chart. When I open up the chart on their website it is the older one. Thanks.

[Investor2014]

Indeed from the 10-Q! The pipeline arrow for FTD using A3-71 is now shaded into Phase 1, which it was not in the October 2018 pipeline chart.

The 10-Q states "approximately $0.9 million was spent on preclinical development activities for ANAVEX®2-73 and ANAVEX®3-71.". I expect that news of the A3-71 P1 trial in FTD will be out soon, an indication for which Anavex have Orphan Drug Designation too. Missling eluded to new indications during 2019 in the December CC.

"Also, included are non-recurring costs of approximately $1.0 million associated with large-scale manufacturing of ANAVEX®2-73 in quantities reserved for potential future commercial use. As the Company has previously produced sufficient batches of ANAVEX®2-73 for existing clinical studies, it is not expected that the Company will be required to incur additional significant manufacturing costs throughout the remainder of fiscal 2019."

I am not sure how much we should read into the quantities for future commercial use. PDD could perhaps achieve accelerated approval in Europe on clear positive results in the P2 study.

Under the PRIME scheme launched in March 2016, it is now possible for applicants to receive confirmation during the clinical development phase that their medicine might potentially be eligible for accelerated assessment.

Accelerated assessment

Missling's answer regarding the analyst question on the PDD rate of enrollment seemed to me to point to rapid completion of enrollment given we are already at over 33% starting from only a few initial trial sites and have had a full house of 20 active sites since early January. Probably June/July.

Also Missling said to expect further detail at the Bio Investor Conference 11th Feb - the sort of place where the upper echelon of bio-checkers can no doubt be found. My guess announcement of P1 trial with A3-71 in FTD and some detail around ongoing trials.

[Bourbon_on_my_cornflakes]

I would expect Fragile X, Angelmans and infatile spasms trials go directly to P2?