Anavex Life Sciences Corp (AVXL)

[polarbear77]

Still many remaining unanswered questions here and I don't know what to expect from tomorrow's conference.

It's strangely been 9 months since new data/charts were last provided; we're obviously still awaiting pk/pd trial data analysis from Ariana to be released; and I can't recall an investor Q&A since last Dec 2016 and that one lasted only for a few short & unfulfilling questions. This gives plenty of ammo for shorts and detractors of the Company and to cause me some concern as well.

That said HOWEVER, can't we STILL make a reasonable determination that the new FDA trial protocols and FDA guidelines are keeping Anavex in neutral until the FDA actually publishes these new guidelines for all companies and the FDA publicly sets forth new protocols from the NEW 21st CCA?

Nidan has kept us updated on this; and it's my understanding that the FDA has not yet made these new changes public yet.

So why would Anavex jump the gun and preempt the FDA's time frame on announcements etc under these new trial guidelines? Shouldn't Anavex navigate the political minefield so as to avoid any costly missteps?

Certainly Dr M understands that investors have been ANXIOUSLY awaiting the above-mentioned lingering questions to be answered.

YET he interestingly decides to pull the 15 month abstract in March 2017; skip AAIC in July; hold onto 15/18/21 month extension trial results for at least 6 months now; and NOT YET p/r the start of any of the 3 trials.

How does one make SENSE of the Company/CEO's above INACTIONS, all the while actually taking these next 5 ACTIONS?:
(1) starting an SEC regulated insider planned stock purchases plan for public visibility about 6 weeks ago (widely acknowledged as a likely show of confidence by the CEO), and
(2) continuing to make positive unambiguous efficacy assertions such as "provides dose dependent cognitive improvement" and "restores cellular homeostasis" in scientific and investor conference abstracts and p/r's to date, and
(3) continue to proclaim as recently as the August 2017 SEC quarterly filing that the 3 trials have been designed and are first of their kind in precision medicine (see quote below), and
(4) deciding to use the 12 month charts from Dec 2016 in June 2017 (positive charts) with older data than what they had in hand at that time in June 2017, and
(5) continue to sign up for upcoming scientific conferences such as tomorrow's 2017 Healthcare Conference and the 11/13 and 11/14 Neuroscience 2017 Conference

4 of the 5 actions insinuate to me that they LIKELY are holding 15/18/21 month extension trial data that would be considered positive and better than current standard of care. Because if they are in possession of unclear/poor/disappointing 15/18/21 month data, they've likely created some big problems for themselves by taking the above 5 actions (again my opinion).

Efficacy will largely determine our future. Surely Dr M knows that this is NOT a game; there are huge players in the mix and billions of dollars on the table.

You DO NOT bluff or overstate your hand when making assertions about CNS disease symptom improvement, do you?

Don't 4 of the above 5 actions make it relatively clear that Anavex believes that their compound works? That they have internal confidence as it relates to the crucial efficacy question?

Again, you don't make unambiguous and assertive statements at this point in time (to the scientific and investment communities) about a2-73's ability to improve CNS disease sufferers' symptoms UNLESS you've sufficient SAB-reviewed trial data to SUPPORT those claims (am I right)???

Therefore isn't the most logical reason for the delay the FDA guidelines and trial protocols announcements/negotiations?

What else could it be? How could the delay be for negative reasons WHILE taking the above 5 actions?

I get that the continuing quiet period is unnerving as h---, but ASIDE FROM THE MONTHS of new-data-silence, has anything been presented or provided to the public that is negative from Anavex?

Let's see if logic prevails here.

All must DYODD. Only invest what you can afford to lose. GLTAL

http://www.anavex.com/anavex-reports-fiscal-third-quarter-2017-financial-results/
"The respective trial designs are based on broad genomic and biomarker characterization, pharmacokinetic and pharmacodynamic modeling including data from patients in previous ANAVEX™ 2-73 trials, as well as preclinical translational science. To our knowledge, this is the first use of this approach in the design of clinical trials for Alzheimer’s disease, Parkinson’s disease and Rett syndrome, and marks a shift towards advancing implementation of precision medicine for these and other neurodegenerative and neurodevelopmental diseases.”