Friday, December 30, 2016 6:23:25 PM
Several topics in the air here. All appropriate, to be considered by all.
There are continuing questions (by some) that the very positive symptom stabilizations or improvements during the recent clinical study can not be used because of the small trial participant numbers (n=25). It is stated that proper clinical trials require much larger populations (say n=300), in both a placebo or control arm, and a parallel experimental arm. Half of the participants, say, 150, in the control arm take a daily pill visually and palatably identical to the Anavex-containing pills the 150 in the experimental arm are taking. Neither the patients nor the doctors or nurses know who’s getting what; only a locked computer recording pill lot numbers. At the end of the trial, the blinded computer data are unlocked and matched against symptoms assessed during the trial. Appropriate statistical procedures are used to crunch and connect the data, which are then plotted (as in the CTAD presentation).
As a biologist, I know this well. The study must be double-blinded (neither patients or doctors know) so only authentic drug-caused results appear. Minimization of placebo effects.
If I were a reviewer of an Anavex clinical trial on humans, to be published in a peer-reviewed journal, all of the above (and more) would be required. Journals don’t like data appearing that were by chance or poor trial design showing unrelated or complicating drug-related phenomena. Bad numbers reveal bad science.
But, when I made my several AVXL purchases (last one just after parsing the CTAD data plots), I did not act upon my knowledge of strict clinical conduct rules, used to obviate erroneous by-chance or bad-influences results. I was (and am) confident in my equity purchases for the following arithmetical reasons.
Although the final trial cohort number was very small (n=25) — normally too small to offer a high-probability rendering of data accuracy — I was convinced otherwise.
Simply stated, all of the participants had one of two things transpire during the clinical period: they either remained symptomatically static or stable, or, actually had symptoms improve. Not a single instance of normal symptomatic decline. How could that be?
Only two explanations. Perhaps by remarkable happenstance, against all odds, 25 trial participants (the entire cohort in contention) just happened to be Alzheimer’s patients who so rarely show no decline over the many months of the trial.
Or, the cohort included typical Alzheimer’s patients, for which symptoms would normally get worse, but they didn’t because of Anavex 2-73 efficacy.
Which was it? An exceptionally atypical sampling of Alzheimer’s patients, all of which either held their symptom progression at bay or even suppressed them, regardless of any putative inefficacy of A2-73; or, do the simple sampling stochastics (probabilities) make the former explanation improbable?
It’s the latter. For those questioning the validity of the trial’s results, attributing them to pure happenstance, where an atypical number of Alzheimer’s patients got included who had rare abilities to innately stop or reverse symptomatic progress, let’s do simplest statistical probabilities for such an outcome.
First, we have to know the fraction of Alzheimer’s patients who (at the mid to mild stages of the disease, as per trial participants) can innately remain symptomatically stable for 52 weeks (or whatever the actual trial period in question was). Frankly, I’ve never read or learned of any spontaneous remission of Alzheimer’s symptoms. Once they appear, they continue to progress undiminished and in ever greater magnitudes.
But, I’ll presume that one percent of Alzheimer’s patients DO have this capability; that’s one out of a hundred, from time to time, who experience year-long remissions in symptom severity increase. For a year, they stay stable, as show on the CTAD plots.
What, then, are the chances of including everyone (n=25) in the trial cohort with such a trait? If the cohort had but one person, the chances of such results would be four percent, one out of 25. But we had 25. What are the chances of stochastic (pure chance selection) inclusion of 25 such symptom-controlling people? Multiply each individual’s chances with all the others.
The chance of this happening — if one out of a hundred Alzheimer’s patients have the rare ability to spontaneously yield flat or ascending favorable symptom data points — is 1E-50. To get 25 of these patients, it’s the number 1 with 50 xeros after it.
But, maybe in the unique population of Alzheimer’s patients the clinical cohort was drawn from, one out of ten had the unique symptom-controlling traits. Much better chance of Anavex inefficacy, then. How much? Just 1E-25. The number one followed by 25 zeros.
I forked over my few hundred dollars to my online brokerage and made my AVXL purchase with the greatest confidence that Anavex 2-73 actually does suppress or reverse symptomatic progression in Alzheimer’s. The many zeros tell it all.
Recent AVXL News
- Anavex Life Sciences to Present at the H.C. Wainwright 26th Annual Global Investment Conference 2024 • GlobeNewswire Inc. • 09/03/2024 11:30:00 AM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 08/06/2024 09:21:05 PM
- Anavex Life Sciences Reports Fiscal 2024 Third Quarter Financial Results and Provides Business Update • GlobeNewswire Inc. • 08/06/2024 11:30:00 AM
- Anavex Life Sciences to Announce Fiscal 2024 Third Quarter Financial Results on Tuesday, August 6, 2024 • GlobeNewswire Inc. • 08/01/2024 11:30:00 AM
- Form 8-K - Current report • Edgar (US Regulatory) • 07/30/2024 09:20:53 PM
- Anavex Life Sciences Announces Translational Biomarker Data for ANAVEX®2-73 (blarcamesine) in Fragile X Syndrome (Major Cause of Autism) at the 19th NFXF International Fragile X Conference • GlobeNewswire Inc. • 07/30/2024 11:30:00 AM
- Form S-3 - Registration statement under Securities Act of 1933 • Edgar (US Regulatory) • 07/29/2024 09:21:49 PM
- Results from Anavex Life Sciences Landmark Phase IIb/III Trial of Blarcamesine Presented at Alzheimer's Association Conference • GlobeNewswire Inc. • 07/28/2024 09:00:00 PM
- Anavex Life Sciences to Present at the H.C. Wainwright 5th Annual Neuro Perspectives Virtual Conference • GlobeNewswire Inc. • 06/20/2024 11:30:00 AM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 06/17/2024 11:30:10 AM
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- 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
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