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Monday, September 25, 2017 9:24:38 PM
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.”
Recent AVXL News
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 06/17/2024 11:30:10 AM
- Anavex Life Sciences Announces Expansion of Leadership Team • GlobeNewswire Inc. • 05/22/2024 11:30:00 AM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 05/17/2024 10:01:00 AM
- Anavex Life Sciences to Present at the H.C. Wainwright 2nd BioConnect Investor Conference at NASDAQ • GlobeNewswire Inc. • 05/14/2024 11:30:00 AM
- Shareholders that lost money on Anavex Life Sciences Corporation(AVXL) Urged to Join Class Action - Contact The Gross Law Firm to Learn More • PR Newswire (US) • 05/10/2024 09:45:00 AM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 05/09/2024 08:35:55 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 05/09/2024 12:00:30 PM
- Anavex Life Sciences Reports Fiscal 2024 Second Quarter Financial Results and Provides Business Update • GlobeNewswire Inc. • 05/09/2024 11:30:00 AM
- The Gross Law Firm Announces the Filing of a Securities Class Action on Behalf of Anavex Life Sciences Corporation(AVXL) Shareholders • PR Newswire (US) • 05/07/2024 09:45:00 AM
- Form DEFA14A - Additional definitive proxy soliciting materials and Rule 14(a)(12) material • Edgar (US Regulatory) • 05/06/2024 10:03:33 AM
- Anavex Life Sciences Corporation Sued for Securities Law Violations - Contact The Gross Law Firm Before May 13, 2024 to Discuss Your Rights - AVXL • PR Newswire (US) • 05/03/2024 09:45:00 AM
- Anavex Life Sciences to Announce Fiscal 2024 Second Quarter Financial Results on Thursday, May 9th, 2024 • GlobeNewswire Inc. • 05/02/2024 11:30:00 AM
- May 13, 2024 Deadline: Contact The Gross Law Firm to Join Class Action Suit Against AVXL • PR Newswire (US) • 04/26/2024 09:45:00 AM
- Contact The Gross Law Firm by May 13, 2024 Deadline to Join Class Action Against Anavex Life Sciences Corporation(AVXL) • PR Newswire (US) • 04/19/2024 09:45:00 AM
- The Gross Law Firm Reminds Shareholders of a Lead Plaintiff Deadline of May 13, 2024 in Anavex Life Sciences Lawsuit - AVXL • PR Newswire (US) • 04/16/2024 09:45:00 AM
- Class Action Filed Against Anavex Life Sciences Corporation (AVXL) - May 13, 2024 Deadline to Join - Contact The Gross Law Firm • PR Newswire (US) • 04/12/2024 09:45:00 AM
- Anavex Life Sciences to Present at the Noble Capital Markets Virtual Healthcare Equity Conference • GlobeNewswire Inc. • 04/11/2024 11:30:00 AM
- Class Action Filed Against Anavex Life Sciences Corporation (AVXL) - May 13, 2024 Deadline to Join - Contact The Gross Law Firm • PR Newswire (US) • 04/09/2024 09:45:00 AM
- Anavex Life Sciences Corporation Class Action: The Gross Law Firm Reminds Anavex Life Sciences Investors of the Pending Class Action Lawsuit with a Lead Plaintiff Deadline of May 13, 2024 - AVXL • PR Newswire (US) • 04/05/2024 09:45:00 AM
- Shareholders that lost money on Anavex Life Sciences Corporation(AVXL) should contact The Gross Law Firm about pending Class Action - AVXL • PR Newswire (US) • 04/02/2024 09:45:00 AM
- Lost Money on Anavex Life Sciences Corporation(AVXL)? Join Class Action Suit Seeking Recovery - Contact The Gross Law Firm • PR Newswire (US) • 03/29/2024 09:45:00 AM
- Investors who lost money on Anavex Life Sciences Corporation(AVXL) should contact The Gross Law Firm about pending Class Action - AVXL • PR Newswire (US) • 03/26/2024 09:45:00 AM
- Anavex Life Sciences to Present at the 23rd Annual Needham Virtual Healthcare Conference • GlobeNewswire Inc. • 03/25/2024 11:30:00 AM
- The Gross Law Firm Notifies Anavex Life Sciences Corporation Investors of a Class Action Lawsuit and Upcoming Deadline • PR Newswire (US) • 03/22/2024 09:45:00 AM
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