Wednesday, November 11, 2015 11:15:31 PM
I do not know if this Comment By User 36926276 A2-73 and Improvement of Regression over Baselineon Seeking Alpha has been posted here, forgive if it has.
Anavex Life Sciences: Interview With Dr. Stephen Macfarlane
http://seekingalpha.com/article/3672856-anavex-life-sciences-interview-with-dr-stephen-macfarlane
Her/His point measuring Regression from Baseline and Improvement Over Baseline: Comparing ACDS-ADL of Axon+DZP, DZP alone and A2-73 REGRESSION from Baseline.
The Astonishing Results: A2-73 Improvement (Raise) Over Baseline
SOC: Axon+DZP, DZP Reduced (slowed)Regression from Baseline
I wish that someone would stress the ACDS-ADL; though we realize it is not 'Stat Sig' YET it is quite significant for a few reasons:
1) Neither Donepezil or Axon have shown the ability to improve ACDS-ADL (Activities of Daily Living ie. every day quality of life capabilities) over baseline. Both have shown statistical significance in reducing the REGRESSION from baseline, DZP over no treatments and Axon+DZP over DZP alone but make no mistake about it patients still REGRESSED over baseline (patients ADL scores prior to starting the drug). This means that for the most part the benefit was 'phyric' in that patients and loved ones got to hear that 'it could have been worse' while experiencing regression in ADL every day.
The fact they show stat sig in reducing regression ALSO means they show stat sig to NOT improve ACDS-ADL over baseline
2-73 IMPROVED ACDS-ADL from baseline in 11 of the first 14 patients EVER to reach the very first milestone, 5 weeks. While that patient pool might not be enough to show stat sig, it is quite quite significant. If SOC and the 'leading candidate' already proved an't improve ADL over baseline even after 6 months and 2-73 does so in 80% of patients in 5 WEEKS then 2-73 is clearly on to something. 11 of 14 patients would have had to ALL experienced something no untreated or DPZ or DPZ-Axon groups ever did; improvement. You can jump all over 'not stat sig' all you want it is tremendously 'sig'. If those #s repeat in the remaining 18 patients as they reach week 5 and are even close to linear improvements by week 12, 2-72 will be well on it's way to proving it is the ONLY AZL drug that can IMPROVE the all important ADL for patients.
This should not be and should not have been understated; sure mention it is not yet stat sig but it is a hairs-breadth from being so even on a small sample size in a short time frame.
2) The P300, which as Avanex pointed out is indicative of other metrics, was almost 4x DPZ at 5 weeks and even better than DPZ was at 6 months. Again not stat sig but highly sig.
3) The MMSE was as good at 5 weeks as DPZ was at 3 months. Again not stat sig but highly sig.
Avanex has every right to communicate those REMARKABLE and promising achievements and did so in a highly responsible manner, reminding people that (simply because of sample size) the results were not yet 'stat sig' and that this was only a safety/tolerability trial (which they passed with flying colors). People who don't understand significance (or don't want to for their own agenda) don't understand that something can be quite *significant* before it is definitively STATISTICALLY so.
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