Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
This is also in the 7/18 EA
That section is part of the copy of the original July 2013 agreement included as reference for the amendment statements
I think there was some confusion because the original July 2013 agreement was included in the document as reference and you those items if you skim through the filing. Yes, both of the recent employment agreements delete the CFO role and the stuff related to Brimberg, etc
One thing to point out here is this entire trial is "Phase 2a" with PART A that was the initial weeks and PART B for which we haven't yet seen data. So presenting "Phase 2a" data can very well include new PART B results.
Dr. Missling is speaking on June 7th @ 3:30pm at the 2016 BIO International Convention in San Francisco. The title of the session is "Casting a Wider Net in Alzheimer’s Research: The Diversity of Today’s Approaches and Signs of Progress". The speakers for this session include Susan Peschin, MHS; Christopher Missling, PhD; Kenneth Rhodes, PhD; Carole Ho, MD; Susan Abushakra, MD and Arnon Rosenthal, PhD. Besides Anavex, these are from companies such as Yumanity, Alector, Denali Therapeutics, etc all working on various approaches to treating Alzheimer's.
Either way, something's afoot, likely good whether for a larger trial or otherwise. Must be a fairly recent development since the different sites are not in sync on it. Cedar Lane Labs shows US Bio as the supplier, too. The main clue I had was that Linscott used to list Tocris as the supplier and now lists US Bio, but you likely have more experience than I in this game ... Cheers!
Linscott lists it from U.S. Biological where it used to point to Tocris and it shows up on US Bio at https://www.usbio.net/biochemicals/254635
Perhaps U.S. Biological gave them a better deal for a larger trial ...
It looks like it may now be available from U.S. Biological instead of Tocris?
Susquehanna is still there with 97,718 shares. And two other filings today show up: Cubist Systematic Strategies and Pinnacle Summer Investments at 17,570 and 50 shares, respectively.
In the paper, memantine in combination with A-273 (and PRE-084, the other Sigma-1 agonist in the study) had reduced efficacy. The paper has results and analysis that shows a synergistic (more than just additive) improvement in efficacy of combo with donepezil. The study included isobologram analyses "performed according to Fraser's concept" and the combination index (CI) for the different combos was calculated from the results. A CI < 1 indicates synergy, C1 == 1 indicates additive behavior, and C1 > 1 indicates a negative effect (less than additive efficacy). The A-273 plus donepezil combo showed synergy for both measures of efficacy in the study. I think is more significant than an "obvious" additive effect that seems to be implied by the examiner's comments. One other note on the examiner's comments is that he mentions that both 2-73 and donepezil bind to muscarinic and sigma-1 receptors and thus have the same mechanism of action, but I didn't think donepezil binds to both?
_Synergy_ of Anavex 2-73 and donepezil is described in Tangui Maurice's new paper. I have the same impression as circa1762 here with regards to it not being clear to the examiner the different methods of action and this paper (which wasn't in the list of references suggested to the examiner) seems to clarify this as synergy is more than just obvious, additive behavior. The paper is titled "Protection by sigma-1 receptor agonists is synergic with donepezil, but not with memantine, in a mouse model of amyloid-induced memory impairments." and the abstract can be found at http://www.ncbi.nlm.nih.gov/pubmed/26386305
From his conclusions in that paper:
"Finally, we also analyzed the combination between ANAVEX2- 73 and donepezil and memantine. We also found with this drug, currently under phase 2a clinical development [84], a clear synergic effect with donepezil. Collectively, our data suggested that the anti- amnesic and neuroprotective effect of selective 1R agonists, or non-selective drugs like ANAVEX2-73, against amyloid toxicity is effective in combination with donepezil. A new, synergic, mode of action could be proposed that may boost the therapeutic efficacy of each drug."
I'm not sure why this reference was not listed other than it is a new publication, pre-published electronically in Sept 2015 but for the January 2016 issue of the journal.
This share count is same as 13 Nov number that I got from the transfer agent on Johnny Bee Good's off week so it actually hasn't changed since 13 November.
Today's outstanding share count is the same as the number I got from the transfer agent last Friday ( 34,600,011) so no new shares were issued this week it seems. I assume the transfer agent has the most recent number at their fingertips (i.e. no delayed information)?
New Anavex 2-73/ donepezil synergy study by Dr. Maurice.
I had posted this on YMB, but there is new paper by Dr. Maurice with the abstract at http://www.ncbi.nlm.nih.gov/pubmed/26386305 relevant to this discussion. Here are the "highlights" from the paper:
• 1 Protein agonists (PRE-084, ANAVEX2-73) are neuroprotective and anti-amnesic in A 25–35-treated mice.
• Their combination with the AChE inhibitor donepezil, but not with the NMDA receptor antagonist memantine, shows synergy for neuroprotective effects.
• The synergy involves combined action at 7 nAChR and 1R.
• Symptomatic effects are purely additive.
In the paper there are results for Donepezil alone, Anavex 2-73 alone, and their combination. (There was also combos with the PRE-084 sigma-1 agonist and memantine)
This paper was accepted in Sept 2015 and will be published in print in the Journal for Behavioural Brain Research, Volume 296, pp 270-278 in January 2016. I think it's also good to see there has been ongoing work in parallel with the current clinical study. The acknowledgments mention "This work was supported in part by Anavex Life Sciences and in part by external resources of the University of Montpellier."
I got an outstanding share count update from the transfer agent at 5:53 EST, 13 November. There were currently 34,600,011 issued and outstanding common shares. So, the count is up only about 190,000 shares in 5 days from when Johny Bee Good got a count on 6 November, or 38,000 per day. I.e., probably ongoing conversion of outstanding warrants, but at no alarming or highly impactful rate or volume.
Is anyone requesting an updated outstanding share count?