Saturday, October 10, 2015 9:58:49 PM
Yes, this is key. The diseases the Anavex compounds, if successful, may effectively treat are all protein related diseases that heretofore have not been effectively treated. This includes a wide category of diseases: AD, PD, AlS, Lewy Body Dementia, etc. (the entire range of neurological diseases). Drugs that successfully treat (or possibly cure) each category of neurological disease would independently be blockbuster drugs, meaning that a drug treating each category has a billion dollar plus market. This quote you include from Abraham Fisher merits repeating:
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The unmatched potency of AF710B on cognition and on amyloid and tau pathologies, combined with its beneficial effects on inflammation and mitochondrial dysfunctions, indicates extensive therapeutic advantages for AF710B in AD and other protein-aggregation related diseases vs. a plethora of experimental and licensed treatments.
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If Anavex 2-73 and related Anavex drugs work you cannot imagine the enormity. Anavex is truly aiming for something transformational. Will its drugs work? People on this board have come up with a number of reasons to believe that Anavex has something that works. We just do not know how effectively these new drugs work. Only time will tell. But, below is a rough list of what people on this board have compiled that lead many of us to believe that Anavex has something that works.
Does the drug work. Here is a list of some things we know that indicate that it it does:
1. The p300 and other metrics made public this summer were positive and dramatic.
2. Patient, caregiver and researcher testimonies have been positive indicating cognitive performance.
3. Patients requested extension of the dosing.
4. The FDA approved the extension of the dosing.
5. Presenters in Barcelona will on November 7 speak about cognitive performance.
What are the odds that the company presenters are planning to travel to the Barcelona conference to present evidence that the drug does not work?
6-passed MJFF due diligence,
7-new appointees to SAB (both Ad and Epilepsy),
8-Dr. V trying to increase his stake at all means..,
9-the pre-clinical epilepsy results,
10-the pre-clinical AD results (before 2A trial),
11.-the other sigma 1 confirmatory findings "Avanir/Otsuko, Concert pharma, MJFF previous work on sigma 1 and others ,allS is positive I am aware of.....including Anavex 371 on sigma-1
12 - What is also important to appreciate, effect was shown in 12 patients and 10 of 12 had an improvement of the signal. So, relatively robust. Not a skewed statistical effect.
13 - Physicians have told us that the safety profile is stronger than donepezil, the bestselling drug on the market.
14 - the initial title for the Nov 7 presentation highlighted cognitive improvement as seen in MMSE scores
15. a tiny american biotech flys in the Study Director who resides in Australia, Steven Mcfarlane, to the conference in Barcelona Spain. This is a doctor who has already said, based on the results earlier released, that he has never seen anything like this drug's apparent efficacy, in his (distinguished) career.
16. a tiny american biotech flys in the Study Director who resides in Australia, Steven Mcfarlane, to the conference in Barcelona Spain. This is a doctor who has already said, based on the results earlier released, that he has never seen anything like this drug's apparent efficacy, in his (distinguished) career
17. Clinical Cognitive Improvement observed in Mini Mental State Examination (MMSE) and other Cognitive Markers". We'll get some Part B data on Nov 7 as well. MMSE data is not collected in Part A, but at weeks 1, 12, 26, 38, and 52 of Part B. By Nov 7 (actually by Oct 14), at least 12 patients will be beyond the 12-week data collection interval. The first patient, at least, will be beyond the 26-week data collection interval.
18. FDA has approved 4 drugs for AD that only temporarily slow worsening of symptoms for 6-12 months in ~50% of patients
19. CEO Missling's constant underpromise and overdeliver approach
20. Missling has been setting up for a successful Phase 3 since March of this year:
http://www.anavex.com/?news=anavex-to-participate-in-phase-3-clinical-trials-panel-at-adpd-2015
We will know more very soon.
Recent AVXL News
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