Replies to post #256491 on Anavex Life Sciences Corp (AVXL)

[jtsmgoblue]

Nidan-what do you mean or are implying when you say a “nominally positive result”?

[georgejjl]

Nidan, I believe that you have a good understanding of statistical analysis of data sets. Please, confirm the following statement of mine.

Top-line results from the Anavex PDD trial should be very easy and quick to analyze using computerized statistical analysis programs that are commercially available.

Below is the list of endpoints for the trial to determine the top-line results:

Quote:
Outcome Measures:


Primary Outcome Measures:

Cognitive Drug Research (CDR) Computerized Assessment System Continuity of Attention [ Time Frame: 14 weeks ]
Change from Baseline to End of Treatment in Continuity of Attention as measured by Cognitive Drug Research (CDR) Computerized Assessment System Continuity of Attention test

Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: 14 weeks ]
Assess the safety and tolerability of ANAVEX2-73 compared to placebo


Secondary Outcome Measures:

MDS-UPDRS Part III Total Score (Motor Scores) [ Time Frame: 14 weeks ]
Change from baseline to End of Treatment as measured by MDS-UPDRS Part III Total Score (Motor Scores)

SDS-CL-25 [ Time Frame: 14 weeks ]
Incidence of sleep disorders symptoms (SDS-CL-25)

https://clinicaltrials.gov/ct2/show/NCT03774459

Good luck and GOD bless,

[Jager997]

To briefly summarize my conversation with IR:
Jager - I have been an investor with AVXL for approximately 5 years… What’s up?
IR – Dr. Missling said the approach other companies have taken with Alzheimer’s disease has failed. That is when he decided to use biomarkers and discovered a couple that seem to respond better to the drug. Of course this approach is taking longer. We are also expanding the trials to include Canada and the UK.
Jager – I expected to hear approval of some kind from the Australian Government by now.
IR – They are waiting on test results from the studies.
Jager - When are you going to provide results from the Parkinson’s study?
IR – I don’t have an exact date but sometime this summer, June, July, or August. Although not likely June since we are at the end of the month. The data is locked but it will take some time to analyze and review the data.
Jager – Have you looked into treating Glaucoma?
IR – Yes we have. But since we are a small company, and running three trials, it would be too much to take on at this time.
Jager – Back some time ago I recall Dr. Missling mentioning you would probably partner going into large scale trial with Alzheimer, phase three study… Is that still on the table?
IR – We want to maintain good value to our shareholders. If we partner with someone part of the proceeds will have to go to the partner. We feel that we can take Rett Syndrome and Parkinson’s treatment to market but would probably need to partner with a manufacturer to meet Alzheimer treatment.
Jager – Thank you for your time. I am looking forward to the Parkinson’s results.
IR – It should be a good summer with the Parkinson’s results followed by the Rett Syndrome results shortly thereafter.