good answer, cdavis, thanks -- understanding the disease does seem to be a work in progress even at the highest levels of scientific understanding (which I am nowhere near)
Thanks for the good reply, pivotal. I just saw the poster for the first time (see Ihub 10321) and noticed that Anavex cites Polich 1990 and Jeong 2004 in support of its statement that "EEP/ERG P300 signal is a real-time physiological measure of cognitive processes with demonstrated sensitivity to Alzheimer's disease and more proximal to disease pathology and pharmacological intervention than psychometric measures." Have you checked out those articles yet? I haven't but will search for them when I have a chance.
But P300 is not the only measure in this trial, and management has already stated that preliminary MMSE and Cogstate data (both FDA-approved measures) are consistent with the preliminary P300 data. Unless management is lying about the correlation (highly unlikely in my opinion), there is no reason to doubt the efficacy for the first 10 of 12 in Part A, or any need for a different trial -- published donepezil data is the placebo.
right, but a company stating that something is true in an official press release is presumably another matter than "just because someone says something," or maybe you were just referring to claims on this message board?
pivotal, I wish I were competent to discuss the correlation with you. My understanding is that part of the purpose of this trial is to help establish that correlation, which as a survey of some of the articles you've already posted about indicates (and thanks for those references), is widely argued but not yet settled as a consensus. In that respect this trial may be just as important to Neuronetrix as it is to Anavex. I assume that measuring EEG/ERP in tandem with more canonical measurements on the effects of a drug that (we hope) actually makes headway against Alzheimer's would add a critical data set to the debate in the scientific community as to whether P300 amplitude deserves the same respect accorded to MMSE, ADSC-ADL, etc.
But I don't have the background to assess properly how reliable the Neuronetrix readouts are on their own. Instead I rely on management's statement that preliminary MMSE and Cogstate measures are consistent with the EEG/ERP data, that caregivers have observed improved brain function in the patients and requested more time on the drug, and on the excellent performance of 2-73 in preclinicals. I have a hard time imagining that MacFarlane (since presumably he is the source) would be willing to ruin his career by lying about the MMSE and Cogstate data and/or the caregiver testimony.
So anyway, I have nothing helpful to add, really, but it's a long way of saying that I appreciate your attempts to bring real scientific discussion to the board and am grateful for the opportunity to learn from those posts. Ultimately, my investment rests on my belief that management is telling the truth about the science, not on any real ability to vet that science myself. I wish it were otherwise, but I still feel great about what appears to be going on here. I guess we'll know for sure soon enough.
it doesn't need to be a cure, though that would be nice
4x better than SOC is plenty good to earn billions per year and give better lives to millions of AD victims and their families
I'm guessing Missling will announce his plan to guide Anavex as CEO for the next 2000 years at the same time as he gives the Phase IIa primary outcomes report.
Anavex PLUS patent (a foregone conclusion, but still potentially catalytic)
epilepsy trial initiated
file for rare disease IND
3-71 trial initiated
increased media coverage
a big institutional buy-in
great response, kdreesen -- way to go to the source
based on preclinals (so far backed up by the preliminary human data), the addition of Anavex 2-73 to the equation should continue to demonstrate significant improvement over donepezil alone in the weeks to come
the fact that patients and their caregivers are observing such benefit that they have requested that the length of the trial be doubled is just as important as the confirmatory data readout
The EEG/ERP data was privileged because the company providing the data (Neuronetrix) is partnered with Anavex in the trial, thus it makes sense to privilege the partner's data and simply refer to other confirmatory readouts without emphasizing them. There is nothing dangerous about believing the management is telling the truth (as it is legally bound to do) when it says MMSE and Cogstate results are consistent with a 38% improvement from baseline. Your suggestion that results half as good as that or worse could still somehow qualify as "consistent" with the EEG/ERP data is outlandish.
dear chicken guy, appreciate the all-caps enthusiasm, but the SEC requirement does not apply to most OTC stocks, which is the reason why the S-1 data has not been accompanied by 13K filings all this time (or accounted for in the data presented by yahoo and other derivative websites)
also, the recent 8k shows that not all warrants have been exercised yet, much less sold
and even if all the ones that have been exercised were sold, that hypothetical selling clearly didn't dampen the rise in pps since the data announcement
can't post links on yahoo
search for New Pills Offer Hope for Alzheimer's Sufferers
was featured on Yahoo Australia (where the trial is taking place)
Prefer AVXL to stay independent, as I think that would be better for patients (and, yes, investors) than putting the drug in the hands of big pharma, though I guess if AVXL stays independent it will eventually rise enough in value to become part of big pharma.
Most here already knows that most Alzheimer's drugs have failed, so why would you expect upvotes for that non-information? It has been explained to you that yes, this trial is exceptional both in that it targets a novel mechanism of action and in the success of its preliminary data.
You might be reaching a bit beyond what the evidence will bear on your conclusion vis a vis downvotes.
I have read your posts as well as those of pivotalchange: 4x is not an interpretation -- 4x is the data based on comparison with published study of donepezil
Plus whatever, you think of EEG/ERG by itself, the trial data is also supported by data from MMSE and Cogstate analysis (approved FDA measurements). Although the details of that support are not released yet, it would be illegal and idiotic of management to lie about it.