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I am wondering how that large bid can remain at this level and in a tight range?
Thank you, and that is a wise strategy.
I agree. Anavex has some form of exclusivity for AVXL 2-73 for AD alone not to mention the exclusivity it may have for all of the other uses. It certainly has 5-7 years FDA exclusivity in the U.S. if efficacy is proven for the treatment of AD and FDA approval is granted. It may also wind up with 20 years from the date of filing (maybe more with patent extensions) patent protection because of the application it has on file in the U.S. relative to AVXL 2-73 as a monotherapy for AD, which may be revived at any time. I addition, more patent protection may be granted (possibly very soon) for AVXL 2-73 combination AD treatment. Remember too that Anavex allegedly has some foreign patent protection for AVXL alone including, but not limited to, that once controversial Greek patent assigned to Anavex.
Anavex has competent patent counsel. I believe more patent protection will be forthcoming.
I disagree with anyone that thinks that a major pharmaceutical company would not be interested in AVXL 2-73 for the treatment of AD. If efficacy is proven, anyway you look at it Anavex has some exclusivity and a valuable drug. With efficacy, companies will be interested
Orveko also said this: "There is a patent application that would protect A2-73 as a monotherapy for the treatment of Alzheimer's, but it has been dormant for years. Maybe there is life in it yet - who knows? "
Orveko posted this: Re: McMagyar Post# 65583
"Agreed that there is much misinformation here and elsewhere. As always, please validate my posts and others' against your own DD. Regarding IP protection, A2-73 is currently protected by one patent related to its use as a combination therapy for the treatment of melanoma. This patent is valid through 2030 or so, but *only* as a combination therapy for the treatment of melanoma. Alzheimer's is not covered in the claims."
However, Orveko also recently pointed out that we should have more patent news soon.
IPman also posted this in May 2016:
ipulator_man Member Level Tuesday, 05/03/16 02:09:22 PM
Re: neiu post# 61503
Post # of 74155
A normal timeline. The application was filed 10/19/2015. It is a combo therapy like the PLUS app. A WIPO patent is preferable to a US only patent.
Here is my updated list:
-------------------------------
Anavex IP Portfolio:
GRANTED PATENT:
U.S. Pat. No. 8,673,931
“Bicyclic Heterocyclic Spiro Compounds” (ANAVEX 3-71, previously AF710B, composition)
U.S. Pat. No. 9,180,106
"Sigma receptors ligands with anti-apoptotic and/or pro-apoptotic properties, over cellular mechanisms, exhibiting prototypical cytoprotective and also anti-cancer activity" (ANAVEX 2-73 Method of use, cancer)
PATENT PENDING:
U.S. Pat. App. No.13/940,352
“Anavex2-73 and Certain Anticholinesterase Inhibitors Composition and Method for Neuroprotection”
U.S. Pub. No. 20140296211 (ANAVEX 2-73 Method of use, Alzheimer's Disease)
WIPO Pat App No.WO2016064711
U.S. Prov. Pat. App. No.62/065,833
“A19-144, A2-73 and Certain Anticholinesterase Inhibitor Compositions and Method for Anti-Seizure Therapy”
Provisional (ANAVEX 2-73 Method of use, epilepsy)
UNPUBLISHED:
U.S. Pat. App. No. 13/777,471
“Sigma-Receptor Ligands with Anti-Apoptotic and/or Pro-Apoptotic Properties Over Cellular Biochemical Mechanisms, with Neuroprotective, Anti-Cancer, Anti-Metastatic and Anti-(Chronic) Inflammatory Action”
Not yet published
Identical to parent U.S. Pat App. No. 12/522,761 / U.S. Pub. No. 20100069484 (ANAVEX 2-73 Composition & Method of use, cancer?)
-------------------------------
The company could PR the preclinical epilepsy results along with this associated patent app this summer.
Thank you Dr Thomas!
§
Learn about the Portfolio that Adapts
Business Partnership: Exclusivity (Patent protection or FDA exclusivity) is a key to consummating an agreement with a business partner. The degree of exclusivity is a major factor in determining value. Of course, if AVXL 2-73 obtains FDA approval, there is a limited exclusivity period regardless of whether Anavex manages to secure patent protection for the drug. Patent protection is governed by the Patent and Trademark Office and generally, runs 20 years from the date of filing (there may be some extensions of the 20 year period and some I mention below). FDA approval involves varying periods of exclusivity as follows:
Orphan Drug (ODE) - 7 years
New Chemical (NCE)- 5 years
"Other" Exclusivity - 3 years for a "change" if criteria are met
Pediatric Exclusivity (PED) - 6 months added to existing Patents/Exclusivity
Patent Challenge – (PC) – 180 days (this exclusivity is for ANDAs only)
Therefore, it is in the interest of both parties to an agreement to develop any drug to wait for more certainty on which period of exclusivity applies before completing a developmental arrangement. I believe in the science behind the drug, and we have had some interesting indications from the clinical trial. I believe that the parties are waiting to settle the exclusivity issue.
Very good, even better than I thought! Thank you.
Again, I understand the registration statement to mean 6,754,609 shares of Common Stock may or may not be sold to Lincoln Park at the discretion and timing of Anavex. For Anavex to sell more, shareholder approval may be needed unless the share price is equal to or greater than $8.94 (the “Minimum Price”). Therefore, unless the share price is $8.94 or greater, shareholder approval may be needed to sell $50,000,000 of stock to Lincoln Park. I do not perceive this as a bad thing. It may be a very good thing.
I really think the company does not need to raise $50,000,00 for phase III. I personally believe that raising another $22,000,000 is more than sufficient. I have done some research on costs of clinical trials.
For example, for costs per patient for a phase III clinical trial. See this:
http://www.phrma.org/sites/default/files/pdf/biopharmaceutical-industry-sponsored-clinical-trials-impact-on-state-economies.pdf
Page 11 shows Estimated Average Per-Patient Clinical Trial Costs, by Phase, 2013 provides a figure of $42,000.00 per patient for a phase III clinical trial.
Assuming the above is more accurate than some poster throwing out figures without citing any basis or making some generalized statement that the AVXL 2-73 clinical trial cannot be done for $50,000,000, I believe this phase III trial can be done for less than $50,000,000.
Granted, costs vary per site and costs may increase from year to year, but even with a 100% increase for the per patient figure given above is $84,000.00 per patient X 300 patients = $25,200,000.
The company has some cash on hand before any sales to Lincoln Park, but let's face it. If it looks like phase lll is succeeding, who cares -- the company will get the funds. If it looks like phase III is failing, the company and its investors, myself included, are subject to losing their investment unless the company succeeds ("pulls it out of their rear" so to speak) on some other basis other than AVXL 2-73 for treatment of AD.
Report TOS
Yes, this amendment states this:
''After the SEC has declared effective this registration statement related to the Financing, the Company has the right, in its sole discretion over a 36-month period, to sell to the Selling Security Holder up to an aggregate commitment of $50,000,000 of shares of Common Stock. The Company controls the timing and amount of any future sales, if any, of shares of Common Stock to the Selling Security Holder."
And even later on this again:
".... we have the right to control the timing and amount of any sales of our shares to Lincoln Park and the Purchase Agreement may be terminated by us at any time at our discretion without any cost to us.''
I understand the registration statement to mean 6,754,609 shares of Common Stock may or may not be sold to Lincoln Park at the discretion and timing of Anavex. For Anavex to sell more, shareholder approval may be needed unless the share price is equal to or greater than $8.94 (the “Minimum Price”). Therefore, unless the share price is $8.94 or greater, shareholder approval may be needed to sell $50,000,000 of stock to Lincoln Park. I do not perceive this as a bad thing. It may be a very good thing.
I really think the company does not need to raise $50,000,00 for phase III. I personally believe that raising another $22,000,000 is more than sufficient. I have done some research on costs of clinical trials.
For example, for costs per patient for a phase III clinical trial. See this:
http://www.phrma.org/sites/default/files/pdf/biopharmaceutical-industry-sponsored-clinical-trials-impact-on-state-economies.pdf
Page 11 shows Estimated Average Per-Patient Clinical Trial Costs, by Phase, 2013 provides a figure of $42,000.00 per patient for a phase III clinical trial.
Assuming the above is more accurate than some poster throwing out figures without citing any basis or making some generalized statement that the AVXL 2-73 clinical trial cannot be done for $50,000,000, I believe this phase III trial can be done for less than $50,000,000.
Granted, costs vary per site and costs may increase from year to year, but even with a 100% increase for the per patient figure given above is $84,000.00 per patient X 300 patients = $25,200,000.
The company has some cash on hand before any sales to Lincoln Park, but let's face it. If it looks like phase lll is succeeding, who cares -- the company will get the funds. If it looks like phase III is failing, the company and its investors, myself included, are subject to losing their investment unless the company succeeds ("pulls it out of their rear" so to speak) on some other basis other than AVXL 2-73 for treatment of AD.
FORM S-3/A (Amendment No. 1) is the heading folks. It is an amenedment to the original filling. The secondary offering pertains to the Lincoln Park agreement. It is controlled by that agreement, which has been public for quite some time. Anavex is not fully implementing its rights under that agreement. I believe it is raising some funds mow for the phase III trial. See my post # 73768. The phase III trial should cost less than $50 mil. As to the primary offering, the company will not be selling any shares without an additional prospectus supplement. This Form S-3/A says this about the primary offering:
Each time that we use this prospectus to sell our securities, we shall also provide a prospectus supplement. For each series of securities, the applicable prospectus supplement will set forth the terms of the offering including:
• the public offering price;
• the name or names of any underwriters, dealers or agents;
• the purchase price of the securities;
• the proceeds from the sale of the securities to us;
• any underwriting discounts, agency fees, or other compensation payable to underwriters or agents;
• any discounts or concessions allowed or reallowed or repaid to dealers; and
• the securities exchanges on which the securities will be listed, if any.
I think that's correct and see this from the plan of distribution that pertains to the primary offering:
Each time that we use this prospectus to sell our securities, we shall also provide a prospectus supplement. For each series of securities, the applicable prospectus supplement will set forth the terms of the offering including:
• the public offering price;
• the name or names of any underwriters, dealers or agents;
• the purchase price of the securities;
• the proceeds from the sale of the securities to us;
• any underwriting discounts, agency fees, or other compensation payable to underwriters or agents;
• any discounts or concessions allowed or reallowed or repaid to dealers; and
• the securities exchanges on which the securities will be listed, if any.
Costs per patient for a phase III clinical trial. See this:
http://www.phrma.org/sites/default/files/pdf/biopharmaceutical-industry-sponsored-clinical-trials-impact-on-state-economies.pdf
Page 11 shows Estimated Average Per-Patient Clinical Trial Costs, by Phase, 2013. It provides a figure of $42,000.00 per patient for a phase III clinical trial.
Assuming the above is more accurate than some poster throwing out figures without citing any basis or making some generalized statement that the AVXL 2-73 clinical trial cannot be done for $50,000,000, I believe this phase III trial can be done for less than $50,000,000.
Granted, costs vary per site and costs may increase from year to year, but even with a 100% increase for the per patient figure give above is $84,000.00 per patient X 300 patients = $25,200,000.
Traditional clinical trials include 1,000 - 5,000 or more patients. Anavex has designed its trials according to newer FDA guidelines to cost less as many long term posters here know.
Presently, about all sleep medications are addictive. Apparently, according to my family doctor, a huge number of people have become "hooked" on these drugs. It would be great if AVXL 2-73 worked for insomnia in place of these current drugs. This would certainly be attractive for a partner to consider.
Yes, the old saying 'ignorance is bliss', but this ignorance may be our bliss.
I like this part: ''It has also been established that the protein’s toxicity is due to the fact that the excess alpha-synuclein disrupts the normal functioning of mitochondria.''
And, here is why: AVXL supposedly restores mitochondrial function.
http://www.anavex.com/?news=anavex-2-73-restores-mitochondrial-functionality-blocks-cell-death-and-oxidative-stress-preventing-onset-of-alzheimers-disease
I grew up in a very isolated remote rural area in the 1940s. I was determined to go places and do things although I did not at the time know where or what. Some people in the area told me I was crazy, people from here don't do that, have never done that, are not educated to do that and can't do that. Besides, you have no money, you are poor (even though you do not seem to realize it). That was a long time ago. I am successful and lucky to be alive. I have never stopped dreaming. Therefore, please forgive me, but I simply do not believe what you say.
Biomarkers are an important factor the FDA may consider in approving a drug. Can someone explain the biologic measures (biomarkers) Dr. Norman Relkin referred to regarding the recent AVXL data. I have done some research that I refer to below separated by ***
***
Dr. Norman Relkin said this about the July AVXL 2-73 data: "It also provided encouraging evidence that previously reported positive trends in certain cognitive and biologic measures persisted over a period of approximately 31 weeks. "
https://globenewswire.com/news-release/2016/07/29/860192/0/en/Anavex-Confirms-Data-from-Phase-2a-Study-of-ANAVEX-2-73-in-Alzheimer-s-Patients-Presented-at-AAIC-2016.html
***
Dr. Relkin is 'a co-inventor on the patent entitled "Multiplexed Cerebrospinal Fluid Markers for Alzheimer's disease" that is assigned to the Cornell Research Foundation.'
https://www.alzforum.org/member-directory/norman-relkin
***
See this article: The evolution of amyloid toxicity in Alzheimer's -- ScienceDaily
'Outsized human suffering is linked to 'amyloid beta,' an otherwise tiny, innocuous-looking protein molecule, as it is suspected to be a key player in neurodegenerative mechanisms underlying Alzheimer's disease. The molecules appear to become toxic within our bodies when they make contact with each other and form small bundles. Oddly, they may become less toxic again as the bundles grow and form ordered fibrillary plaque deposits. This begs the question: what's different about these bundles?"'
https://www.sciencedaily.com/releases/2016/03/160301144750.htm
***
Antibodies could be key defenders against Alzheimer's, new evidence shows:
By Jonathan Weil
In a major advance in the battle against Alzheimer's disease and related forms of dementia, researchers at NewYork-Presbyterian Hospital/Weill Cornell Medical Center have identified naturally occurring antibodies in human blood that may help defend against the buildup of harmful plaques in the brain.
The newly found antibodies selectively target aggregates of beta amyloid proteins that are toxic to brain cells, while ignoring the benign single-molecule forms of the same proteins. The existence of such antibodies was predicted by animal studies, but they were never previously demonstrated to be present in substantial quantities in blood from normal humans.
Lead researcher Norman Relkin, a behavioral neurologist and neuroscientist at NewYork-Presbyterian Hospital/Weill Cornell Medical Center, presented the findings at the second Alzheimer's Association International Conference on Prevention of Dementia, June 11 in Washington, D.C.
http://www.news.cornell.edu/stories/2007/06/antibodies-could-defend-against-alzheimers-researchers-show
***
In the transgenic amyloid expressing mouse model Tg2576, where the sigma-1 receptor (S1R) expression is impaired through S1R KO (knock out), at 12 months the survival was reduced by 50% compared to the non-S1R KO Tg2576 model. Apparently the genetic inactivation of the S1R gene worsens amyloid toxicity and has a detrimental impact on survival and also memory impairment. Amyloid is believed to play a key role in the development of the symptoms of Alzheimer’s disease (AD). On the other hand, activation of the S1R through treatment with the S1R agonist ANAVEX 2-73 in the Tg2576 model alleviates amyloid toxicity and resulting learning deficits both after one month and two months daily oral treatment, respectively. In addition expression of ROS (reactive oxidative species) as well as plasticity related IEG and transcription factors in the mouse hippocampus were clearly negatively impacted through the S1R KO, however, were significantly improved through ANAVEX 2-73. This confirms that targeting the S1R, a key factor in brain plasticity, may demonstrate neuroprotection in Alzheimer’s disease. ANAVEX 2-73 is currently undergoing a Phase 2a trial in Alzheimer’s patients.
http://www.anavex.com/?news=anavex-presents-positive-results-for-both-anavex-2-73-and-anavex-3-71-in-alzheimers-models-at-2015-adpd-conference
***
ANAVEX 2-73 demonstrated to be effective on functional responses and biochemical markers of the toxicity developed in Tg2576 mice. Interestingly, the compound only marginally decreased soluble amyloid-beta brain contents. Since many therapeutic strategies based on lowering amyloid-beta have failed, it is quite possible that amyloid-beta reduction does not correlate directly with disease improvement.
http://www.anavex.com/?news=anavex-announces-positive-data-for-anavex-2-73-in-alzheimers-disease
Yes, besides the importance of dosing ranges and safety, he says this: "It also provided encouraging evidence that previously reported positive trends in certain cognitive and biologic measures persisted over a period of approximately 31 weeks. "
That takes integrity. I'm glad you are back.
CBD : I finally got a chance to watch this video you referenced. It is fascinating. It may also help explain the therapeutic responses we have been hearing about with patients in the AVXL 2-73 clinical trial, which may be the result of sigma 1 drugs link to the body's endocannabinoid system. Thank you for posting this.
Yes, pending patent approval makes good sense.
I have done the same - buying at $3 - 3.03.
Well done, and you are very kind for sharing this with the board.
Mikesc is correct in his post to F1ash. The data is promising. Dr. Hooper wrote a good article published in Seeking Alpha today. A person, Maybull, made a negative comment about Dr. Hooper's article implying that the data from AVXL's clinical trial was not promising and that all Maybull wanted to know was whether it worked or not. A response to Maybull that I thought was good was as follows: "Maybull is simply argumentative. Maybull, you may be interested in knowing that no FDA approved AD drug is "working" so far. However, the clinical trial for AVXL 2-73 has established safety. Furthermore, the limited number of people in this trial show no significant cognitive decline and there have been unexpected therapeutic responses such as improved engagement with family and friends, improved mood, increased independent activity, feeling happier, improved alertness, better coordination, and better coping. All of this, no significant cognitive decline and the unexpected therapeutic responses, are at this point I believe better than any drug that has been approved by the FDA for the treatment of AD. That may not be understood by you to be "promising", but it is thought by patients in the trial to be promising. Patients have requested that the trial be extended so they may remain taking AVXL 2-73. Of course, the point of a P3 is to prove efficacy."
AVXL 2-73 is better than Aricept if this clinical trial only shows that there is no significantly statistical cognitive decline patients in the trial at 52 weeks or even if there is a decline in MMSE scoring of less than 3.
AVXL 2-73 is also better than Aricept if it shows and continues to show this:
'Therapeutic Response Unexpected'. A sample of verbatim terms reported include:
Improved Engagement with Family/Friends
Improvement in Mood
Increased Independent Activity
Feeling Happier
Improved Alertness
Better Coordination
Better Coping
Thank you for posting.
Yes, and during that 5 year period, Anavex may be able to develop an improved version AVXL 2-73 that they and their partner could switch the market to upon expiration of the 5-year exclusivity. For example, if AVXL 2-73 may be combined with another chemical entity that will be more effective than 2-73 alone, it may be that his combination is patentable.
Got it! Enlightened! Thanks.
CBD: Do I understand this correctly to mean that a combination of Anavex's "sigma-1 drugs candidates and cannabinoids" would be used in studies? If that is correct, then I believe that raises the possibility of a patent application for a combination therapy that may provide important exclusivity/protection for the combination of sigma-1 drugs and cannabinoids. Do you know anything about when these studies may take place?
I also like the idea of this because of the possibilities for application of this therapy to other diseases and medical problems beside Alzheimer's such as pain, mental diseases, etc.
Thank you.
Good for you, and remember too that Anavex is not a one trick pony. As we all know, it has several other possibilities besides the potential for treating AD disease.
I have submitted FOIA requests before on other matters. Typically, it takes several, if not many, months to receive a response l. However, it does not hurt to try. The sooner you file your request, the better.
The pharmacodynamic results that this analysis shows, if published, is going to be in connection with a small number and from what Dr. Relkin also said yesterday it may be "unreasonable" to draw any conclusions from the analysis. Moreover, due to the pending lawsuit, I think any comments by Anavex will be guarded. However, if the PD results on its face appears to be positive, I can envision a bump up in the share price especially since I believe the down move was an overreaction. But, based on the what has historically occurred, the shorts will be waiting for another opportunity as soon as there is a recovery in share price. Remember, the last Seeking Alpha short seller artice from the other day, which had no effect, said longs can relax because this will be our last article for a while. Barring an impressive business parter arrangement to discourage short selling, the shorts will be waiting, but they too need a price recovery before attempting to take it down again. We would like to see a price recovery, and the shorts desire to see that too. We are likely to see a recovery, I think.
Dr. Norman Relkin, MD, PhD, an Alzheimer clinical trialist and an advisor to Anavex, said yesterday, July 29, 2016, in the press release that: "Detailed pre-planned analysis of the pharmacodynamic results is in progress, which is one of the key factors of relevance for regulatory agencies and which will also determine the optimal dose for future studies."
I suppose the analysis of PD determines the oprimal dose of the drug most likely to obtain the desired effect in the body, and that determination key to arriving at the number of trial participants and the length of the trial the FDA may accept for p3.
This artice provided by bsparks: http://www.dddmag.com/article/2007/09/modeling-success-pkpd-testing says:
"PK/PD modeling can greatly compress timelines by enabling companies to utilize PK/PD data collected in phase I trials," says Graham. "Instead of a sequential approach, modeling enables a parallel approach, helping jump-start phase II and phase III trial designs. This can significantly reduce the development time at every phase. Added benefits of PK/PD modeling are optimized dose regimens resulting in smarter phase II and phase III trials with a decreased risk of drug failure at the final stage." He cites the example of a company that benefited from PK/PD modeling at the phase IIb stage by eliminating the need for an additional dose group, thereby reducing the sample size by approximately 60 patients, something that saved six months and more than $1 million.
Thus, it saves time and money. The question is: How much time and money for this AVXL p3 trial?
I agree. I maintained my position. I made it to the beach. There is only one way to move and that is forward!
The reality is that stock market participants constantly overreact to new information. Many of us overreacted previous to the news with high expectations. The news as reported warranted a move down I believe, but I think we are now seeing an overreaction to the downside.
I have been reading the back and forth on this board for the last two days. My best judgment is that it is premature for anyone to say anything definitively. Therefore, I will maintain my long position waiting to see what results emerge at week 52.
Alzheimer's Experts Call for End to Under-Treatment of DiseasePR Newswire(Sun 8:00AM EDT).
Doctors Say Evidence Supports Use of Current Drugs, Evaluation of New Cholinergic Medicines That Address Cognition and Function, Not Just Focus on Research for Cure
Here's a link:
http://www.prnewswire.com/news-releases/alzheimers-experts-call-for-end-to-under-treatment-of-disease-300302936.html
Alzheimer's Experts Call for End to Under-Treatment of Disease
Doctors Say Evidence Supports Use of Current Drugs, Evaluation of New Cholinergic Medicines That Address Cognition and Function, Not Just Focus on Research for Cure
PR Newswire Axovant Sciences Ltd.
6 hours ago
????
TORONTO, July 24, 2016 /PRNewswire/ -- Several physicians recognized for their contributions to clinical research and advances in the treatment of people with Alzheimer's disease today called for immediate changes to how healthcare professionals approach the management of the disease.
Citing statistics that show a lack of diagnosis and use of currently available prescription medicine proven to have important positive clinical impact, Gary Small, M.D., and Rachelle Doody, M.D., Ph.D., said that better education of primary care doctors to eliminate misconceptions is a critical first step to give people with Alzheimer's disease a "fighting chance." They emphasized that drugs that affect the cholinergic system are the only drugs shown to have a positive impact on all stages of Alzheimer's disease – this has been established by two decades of clinical trials and real world observational studies. Furthermore, they also pointed out new data published by Dr. Harald Hampel, M.D., Ph.D., supporting important, new information on the role medicines targeting the cholinergic system may have in Alzheimer's patients.
According to the Alzheimer's Association and published research:
46.8 million people worldwide1 and 5.4 million people in the United States2 are thought to be suffering from Alzheimer's disease, with the numbers expected to reach 120 million globally by 2050.
Less than 50% of affected individuals are correctly diagnosed with Alzheimer's disease3.
Less than 25% of the diagnosed patients receive treatment4.
If prescribed treatment, less than 50% of people suffering from Alzheimer's disease remain on therapy after 4 years5.
"It is unfortunate that only a minority of primary care doctors believe they have received sufficient training to diagnose the disease," commented Dr. Small, Director of Geriatric Psychiatry at UCLA's Semel Institute for Neuroscience and Human Behavior. "We see patients regularly for whom the diagnosis of Alzheimer's was missed. Unfortunately, the result is people with the disease are not getting treated. This robs them of the ability to perform everyday tasks independently and maintain quality of life. We must change this now. We know that research to find a cure is important. But so, too, is clinical research of medicines that can make an impact sooner."
"Unfortunately, there is a general misconception among some doctors and patients that cholinesterase inhibitors do not provide much benefit," said Dr. Doody, Professor of Neurology and Director of the Alzheimer's Disease and Memory Disorders Center at Baylor College of Medicine. "Years of study have shown that they do, and, therefore, it is very important to treat patients to preserve as much cognition and function as possible – it is important to treat them immediately after diagnosis to slow down progression of symptoms. This improves the quality of life for individuals and families affected by the disease."
"Results of our recently published brain imaging studies add to the growing amount of clinical and scientific evidence that supports the importance of the cholinergic system in the treatment of Alzheimer's disease. Hopefully, we will soon get additional innovative compounds and therapies that will further enhance the cholinergic brain system. Companies like Axovant and others are in the late-stage development process of such novel compounds. If they are successful with the development of these compounds, then we believe they could be used in combination with standard of care therapies that we have today. That's really good news for patients and caregivers," said Dr. Hampel, Professor at the Department of Neurology, Marie Curie University and AXA Research Fund Excellence Chair (Sorbonne Universities), and representative of the Hippocampus Study.
In summary, some of the most prominent physicians in the field of Alzheimer's disease call for immediate action: patients consulting their physicians about possible early signs of Alzheimer's disease, physicians carefully assessing these patients, and in case of positive diagnosis – prescribing appropriate medications targeting the cholinergic system to ensure maximum benefit.
Alzheimer's is the most common form of dementia, a general term for memory loss and other intellectual abilities serious enough to interfere with daily life. Alzheimer's disease accounts for 60 to 80 percent of dementia cases. It is a progressive disease, where dementia symptoms gradually worsen over a number of years. In its early stages, memory loss is mild, but with late-stage Alzheimer's, individuals lose the ability to carry on a conversation and respond to their environment. Alzheimer's is the sixth leading cause of death in the United States6.
For more comments from Dr. Small:
This part is intriguing ('Therapeutic Response Unexpected'). It will probably be said that all of this may be due to the placebo effect. Can all of these events be attributable to the placebo effect? Increased independent activity and better coordination are two that seem to me to be most unlikely to be due to a placebo effect.
16 events reported I think needs explaining, and I am not sure why the poster uses preferred term 'Therapeutic Response Unexpected'. That term being in single quotes indicates it is a quote of someone's quote, I guess?
Does anyone know if events like this have ever been reported in any other clinical trial of an AD drug?
'Therapeutic Response Unexpected'. A sample of verbatim terms reported include:
Improved Engagement with Family/Friends
Improvement in Mood
Increased Independent Activity
Feeling Happier
Improved Alertness
Better Coordination
Better Coping
I fully agree. We have done the work, which indicates the science behind this class of drugs is an answer to treating CNS diseases. It is new, relatively unknown, and in the long drawn-out process of validation. Exercising patience is the key. If you are right, sit tight. Don't become impatient and lose your position or as some have said to keep a core position.
I believe we need to manage our expectations. What may seem to be obvious to us is foreign to others. All of these "others" out there will likely approach any new and encouraging developments with suspicion.
I am not proficient at technical analysis, but today's share price movement wedge wise to me indicates a move higher. A move up seems, fundamentally and technically (according to others on this board -- see Tom's posts), extremely likely for tomorrow. I would not be spooked by any of the feints otherwise. If not up, the share price at the very least should not head down very much barring some dramatic surprise. Now as for next week, no one can predict the future. However, based on the events about to occur over the weekend (Sunday), and with the other events during the week with whatever may develop at the conference in between the odds of shorts losing money in the following days is most likely. For me that is not a bad thing -- shorts losing money. Get the picture?