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The FDA has a procedure for approving generic substitutes. Among other things, bio-equivalence must be proven. See also the Hatch-Waxman Act, briefly described as follows:
Hatch-Waxman amended the Federal Food, Drug, and Cosmetic Act. Section 505(j) of the Act, codified as 21 U.S.C. § 355(j), outlines the process for pharmaceutical manufacturers to file an Abbreviated New Drug Application (ANDA) for approval of a generic drug by the Food and Drug Administration (FDA). Section 505(j)(2)(A)(vii)(IV), often referred to as Paragraph IV, gives the first company to file an ANDA for a particular drug 180 days of exclusive rights to market the drug as the generic alternative to the branded drug. The 180 days begins on the first day of marketing the drug under the ANDA, if the paragraph IV certification is not challenged by the pioneer manufacturer. If the paragraph IV certification is challenged by the pioneer manufacturer, the 180 days begins on the date a court finds that,as required under paragraph IV, the patent of the pioneer manufacturer was not valid, enforceable, or not infringed.
The Act enables a generic pharmaceutical manufacturer to develop copy of a patented innovator drug without duplicating the clinical and non-clinical studies or risking liability for patent infringement damages. The generic manufacturer must only demonstrate bioequivalence to the innovator.
CBD: You are correct, but it's also better to have a monopoly on AVXL 2-73 and donepezil to be administered in one pill.
The combination patent is important. If granted, Anavex will, for the duration of the patent, have exclusive rights to the combination of AVXL 2-73 and donepezil in one pill with the optimum dosage of both drugs. One pill is also better for patient compliance.
I have not had time to read very many posts the last several days. However, if Aricept (donepezil) has gone generic, which I understand is the case, it is off patent - meaning the patent has expired. Anavex though may obtain a patent for the combination of Anavex 2-73 and donepezil in one pill. If the combination patent is not granted, the question remains about whether AVXL 2-73 will be approved by the FDA.
AVXL is obviously being used in combination with AVXL in clinical trials.
It seems that even without Anavex obtaining a patent on the combination of AVXL 2-73 and donepezil (if AVXL is approved by the FDA), AVXL 2-73 may be prescribed as an add on therapy to donepezil. Of course, it is much more valuable for Anavex though to have a patent on the combination of 2-73 and donepezil to be administered in one pill rather than the two drugs to be taken separately.
The scoundrel, Martin Shkreli! The New York Times report this morning also says this: " He became known for shortselling the stocks of biotechnology companies — betting the stock price would fall. He also publicly disparaged the companies he was betting against, in some cases taking the unusual step of writing to the Food and Drug Administration to argue that the agency should not approve a drug made by a company whose stock he was shortselling."
Alzheimer's article in Runner's magazine by Greg O'Brien: "In My Bewildering, Terrifying, Race Against Alzheimer's, Quitting Isn't An Option". Read it if you can. He is in his sixties. Alzheimer's runs in his family. He is experiencing the disease now, and he provides a provocative description of what it is like to have Alzheimer's in its early stages. We must succeed.
Minotaur: Thank you, and it is time for a revolution in AZ therapy!
I agree. We are just getting started, although I am know there will be battles ahead of us. This board, however, is a great resource in support of the company, the science, and each other. As I said, I too am committed. Missling's efforts are impressive. This board is impressive as well. We all have doubts at times, but may the good folks win this one! I am betting a great deal that we will!
Today was a good day. I have owned AVXL stock for well over a year. But to stay with my investment, I have found it necessary to keep reminding myself about this: Innovative ideas have to be lonely. By definition, new ideas, in this case a completely new line of drugs, are non-consensus ideas. Anavex is attempting to develop drugs that are disruptive.
Although major pharmaceutical AZ drugs do not work, you must remember that these pharmaceutical companies are earning billions of dollars from their drug monopolies that do not work. New ideas are always uncomfortable. Non-conformists don’t enjoy the warmth that comes with being at the center of the herd. Unconventional ideas often appear imprudent. It has been easy for AF and others to be critical of the Anavex innovation.
What AVXL is doing is something that NOT "what everyone does.” Most of the other drug companies, big pharma, are doing something else -- something else that's not working. So, remember this foremost: You will never make any serious money doing what everyone else does! Nevertheless, only invest money you can afford to lose. I hope everyone realizes the risks inherent this Anavex venture.
Think about what I have said. As you should know by now, we face more than our fair share of forces that do not desire to see Anavex succeed no matter how good the science. If successful, Anavex will be revolutionary. Revolutions are not easy to accomplish no matter how badly a revolution is needed.
Personally, I remain encouraged. I am committed. Since my initial investment over a year ago, I have added along the way, including this week. I am glad I did. I would like to see Anavex succeed with drugs that work where others fail! Do be careful, and I wish you the best of luck!
1.10 million.
And the patent office approved fake patents - everyone in Washington is in on this scam.
Even the FDA is faking it. My goodness gracious!
The inventors, mice, clinical trial staff, scientific board, all authors of all scientific articles, all employees, and all patients are all faking it.
From what I understand, Japan, for example has shortened drug approval/entry. Phase 3 may be eliminated. If an AZ drug is safe and give any indications it may work, it ought to be between patients and their doctors.
So what! Every drug that has been developed has at one time been without a trial. Although, it is inaccurate to simply say Anavex has been without a trial.
NAD Protects Neurons? I started looking into what was said in the article someone posted yesterday entitled: Mad Cow Research Hints At Ways To Halt Alzheimer's, Parkinson'sThere may be something to NAD that relates to Anavex 2-73 and why it may work? That article (cited below) quoted Corinne Lasmezas, a neuroscientist and professor at Scripps Research Institute and what she had to say about NAD. The article appears here: http://www.npr.org/sections/health-shots/2015/03/09/390980364/mad-cow-research-hints-at-ways-to-halt-alzheimers-parkinsons
Scientists used to believe that aging was caused by mutations in the genetic blueprint of the cells – a theory that, according to Dr. David Sinclair (see below) , may still apply in later life – but if the earlier phases of aging are caused by a drop-off in NAD+ levels, as Dr. Sinclair’s research indicates, some aspects of aging could theoretically be reversed.
David Sinclair, Ph.D. is Co-Director of the Paul F. Glenn Center for the Biology of Aging, a Professor of Genetics at Harvard Medical School, Associate Member of the Broad Institute for Systems Biology, and co-founder of Sirtris Pharmaceuticals, Waltham, MA. Dr. Sinclair’s research aims to identify conserved longevity control pathways and devise small molecules that activate them, with a view to preventing and treating diseases caused by aging. His lab was the first to identify small molecules called STACs that can activate the SIRT pathway and extend lifespan of a diverse species. They also discovered key components of the aging regulatory pathway in yeast and is now focused on finding genes and STACs that extend the healthy lifespan.
According to Wikipedia:
"Sirtris Pharmaceuticals, Inc. was a biotechnology company based in Cambridge, MA that developed therapies for type 2 diabetes, cancer, and other diseases. Founded in 2004 by Harvard University biologist David Sinclair, venture capitalist Christoph Westphal, and serial entrepreneur Andrew Perlman, the company went public in 2007 and was subsequently purchased by GlaxoSmithKline in 2008 for $720 million. It was operated as a business unit of GSK until 2013, when it was absorbed into GSK, where research and development continues.[1] Sirtris's drug discovery was focused on developing activators of sirtuins, a class of enzyme that may mediate benefits of calorie restriction. The company's current lead candidates are SRT2104 and SRT2379, which are both potent activators of the SIRT1 enzyme. These and related molecules are in clinical development. The company's other drug candidate was SRT-501, a proprietary formulation of the compound resveratrol, possibly an activator of the SIRT1 enzyme.[2] Development of SRT-501 was halted by GlaxoSmithKline in late 2010, due to suspected drug-related adverse effects in study participants. The company later focused on developing more potent synthetic activators of SIRT1 and is investigating SIRT3 as another potential drug target.[3] Studies from rivals Amgen and Pfizer cast doubt on whether SIRT1 was directly activated.[4][5] Subsequent work provided evidence that the original conclusions of Sinclair were correct: SIRT1 is directly activated by resveratrol and the synthetic activators, with the activator binding in the N-terminus of SIRT1.[6] A mutation in this N-terminal SIRT1 domain (SIRT1-E230K) was shown to block activation by resveratrol and by synthetic activators from Sirtris, both in vitro and in vivo, largely settling the scientific debate. In 2014, SRT1720 and SRT2104 were shown to extend the health span and the lifespan of mice on a standard diet."
See Seeking Alpha article "Anavex 2-73: How It May Work" $AVXL. http://www.seekingalpha.com/article/3734766
This article concludes that IF Anavex 2-73 is a, "particularly good hydrogen donor" it may reverse damage that oxidation and nitration has done thereby reversing AZ?
See also:
http://www.npr.org/sections/health-shots/2015/03/09/390980364/mad-cow-research-hints-at-ways-to-halt-alzheimers-parkinsons
"What we found is that if you replenish NAD in these neurons, it completely protects them against the injury caused by misfolded prion protein," Lasmezas says.
That suggests the right drugs could protect brain cells from the misfolded proteins involved in Alzheimer's and Parkinson's and ALS, Lasmezas says."
See https://en.m.wikipedia.org/wiki/Hydrogen_carrier. NAD is a hydrogen carrier.
Could it be that Anavex 2-73 may be a hydrogen carrier or it may replenish NAD (a hydrogen carrier) in neurons? Can someone more knowledgeable explain this?
Below is a couple of paragraphs from the internet about hydrogen carriers and the role they play in the body.
A hydrogen carrier is an organic macromolecule that transports atoms of hydrogen from one place to another inside a cell or from cell to cell for use in various metabolical processes. An example is NADPH in photosynthesis also called NAD along with it FAD is also one of the hydrogen carriers.The main role of these is to transport hydrogen atom to electron transport chain which will change ADP to ATP by adding one phosphate.
Adenosine triphosphate (ATP) is considered by biologists to be the energy currency of life. It is the high-energy molecule that stores the energy we need to do just about everything we do. It is present in the cytoplasm and nucleoplasm of every cell, and essentially all the physiological mechanisms that require energy for operation obtain it directly from the stored ATP. (Guyton) As food in the cells is gradually oxidized, the released energy is used to re-form the ATP so that the cell always maintains a supply of this essential molecule. Karp quotes an estimate that more than 2 x 1026 molecules or >160kg of ATP is formed in the human body daily! ATP is remarkable for its ability to enter into many coupled reactions, both those to food to extract energy and with the reactions in other physiological processes to provide energy to them. In animal systems, the ATP is synthesized in the tiny energy factories called mitochondria by a process called glycolysis.
Maybe someone here can make more sense of all this, but it does seem that, according to Corinne Lasmezas, replinishing NAD
In neurons protects them against injury. NAD tends to diminish as we age. AZ is a disease prevalent in the elderly. The Seeking Alpha article published last week "Anavex and How it May Work" seems to be related to what Lasmezas said in the Mad Cow article re NAD.
Well said!
Man, that is easier, and it makes me feel much better! I can do without the free pills, but I may need new glasses.
I plan on being there with my shares although I will be 90 years old at that time, seriously. Hopefully, the company will be handing out free pills. I may need them to get through the meeting.
At this juncture, shorting AVXL is a good way to turn a small fortune to no fortune or to turn a large fortune to a tiny fortune. Remember, next week there will definitely be more good news (December 7), and before long we will hear more about the ongoing clinical trial -- not to mention many other potentially positive developments such as a BP, etc,
A short sale restriction is in effect. The U.S. Securities and Exchange Commission has issued a rule to restrict short selling under certain circumstances. Under the alternative uptick rule, trading halts when the market price of a security declines 10 percent in one day. Once triggered, the rule remains in effect for the remainder of the trading day and all of the next trading day. The restriction does not allow a short sale to occur at a price equal to or less than the highest current nationwide offer to purchase the security. In this way, short sales cannot drive down prices without an intervening uptick in price.
Yes, I believe we are in stronger hands, and that's why I am buying more.
Great news for the people that need and deserve the drug(s) at these prices, and the hog gets slaughtered.
Yes, good sign. Light volume. Solid as a rock!
Anavex Announces Preparation of Regulatory Filings based on Guidance From the FDA
New York, NY – November 18, 2015 – Anavex Life Sciences Corp. (“Anavex” or the “Company”) (Nasdaq: AVXL), a clinical-stage biopharmaceutical company developing drug candidates to treat Alzheimer’s disease, other central nervous system (CNS) diseases, pain and various types of cancer, announces that it is moving forward with the development program for ANAVEX 2-73. Guidance received from the FDA confirms the Company’s strategy to advance ANAVEX 2-73 for the treatment of Alzheimer’s disease in a larger double-blinded, randomized, placebo-controlled Phase 2/3 trial.
Buy AVXL before Thanksgiving.
This company took action in response to a recent short attack!
Applied DNA Sciences Identifies Suspects in Short Attack
Persons of Interest Reported to State and Federal authorities
STONY BROOK, NY--(Marketwired - November 19, 2015) - Applied DNA Sciences, Inc. (APDN) (Twitter: @APDN), a provider of DNA-based anti-counterfeiting and anti-theft technology, product genotyping and product authentication solutions, announced that working with former law enforcement officials, it has identified two persons of interest believed to be involved in the short attack on the company that was perpetrated October 29, 2015. The identities of the suspects have been reported to federal authorities and will be reported to states Attorneys General.
APDN believes that the misstatements in the short attack were a deliberate effort to manipulate the stock price coincident with a quadrupling of the short positions.
Furthermore, the forensic IT investigation revealed that one of the suspects has a background in finance and has been previously fined and ordered to cease and desist operation of an unlicensed investment advisory firm. Given the suspects' backgrounds, the research dedicated to the short attack, and the false and misleading statements and innuendos stated in the short attack, APDN's management believes the short attack is an example of a coordinated, organized stock manipulation to achieve personal gain by the attackers.
Current after hour share prices above 6 are extremely bullish. As of today, money flow should be up sharply. AVXL was extremely oversold (an exaggeration that was not deserved). Fundamentals are very positive. The science is sound. Relative strength should increase.
Thank you, Circa. Forget the money, I could not live life inside little martin's skin.
Some messages appear on the KBIO Yahoo message board about shorts bankrupted by the unbelievable and, to me, inexplicable rise in KBIO share price after hours. Talk about dangerous.
Yes, safety and absorption have been established. Presently, the FDA is of the mind to approve this drug for AD if it is shown in this larger trial that it has any degree of efficacy at all. Safety is of utmost importance to the FDA. All of this is extremely encouraging -- especially with what we know about the science. Remember too, that none of the other AD drugs on the market work with the possible exception of Aricept. Do not be concerned about Adam F saying things, including his ridiculous comment about Anavex 2-73 making some patients dizzy. All CNS drugs make some patients dizzy (blood pressure and other drugs do too). Frankly, Aricept makes some patients dizzy - the FDA approved Aricept knowing it made some patients dizzy!
Permission to move to a phase 3 is of great importance. Only about 33% of drugs in clinical trials make it. You can confirm this on the FDA website. With what many on this board know about the science behind Anavex drug therapy combined with moving forward to a larger study is very significant. All of this means that the odds of getting approval of Anavex 2-73 and/or the combination with another drug already approved by the FDA (Aricept) are much higher than ever before.
I do not believe you brag. You state facts in my opinion. Thank you.
I am steadily adding to my long position. I am doing so with money that I can afford to lose, although it is definitely not my desire to lose in the long run. If circumstances arise, I may change or exit my position. I have read all the recent attacks and comments about the company. I have not seen anything of substance that warrants any change in my strategy, which is to continue to accumulate shares. I know of nothing about the company as it exists today, the clinical trials and/or the science behind the AVXL drug development that justifies any change in my long position/strategy. I cannot explain the steep drop in share price, but it has been my experience that stock price movements are often overdone. Perhaps this move down is simply exaggerated? I certainly believe that it has no relevance to fundamentals.
"Keep your head straight when all about you are losing theirs." So far, the Anavex 2-73 clinical trial has met its goals, and safety has been established. This is highly meaningful, because safety is first and foremost a primary concern of the FDA.
Efficacy is to be proved or disproved in the ongoing clinical trial although the science behind the development of Anavex drug therapy is encouraging. Efficacy is certainly not an appropriate topic by me, a political scientist (Adam F) or short sellers (Martin S) or anyone else. It is important, however, that the Anavex 2-73 clinical trial has given indications that have been described as "encouraging" by scientists and medical practitioners. Any further comments or conclusions about these indications should be ignored, because these comments and conclusions are truly meaningless.
Briefly, I have tried to look generally at stages of FDA clinical trials, and how the Anavex study or trial is proceeding (SOME OF MY NOTES OR COMMENTS ARE IN ALL CAPS WITH PARENTHES):
Phase I:
The first investigation of a potential new drug in people, to determine how the drug reacts in the body, and how the body reacts to the drug – how it is absorbed, distributed and metabolized or altered / used by the body. Commonly conducted in a small number of healthy volunteers. (ANAVEX 2-73 PHASE HAS SUCCESSFULLY COMPLETED PHASE ONE.)
Phase II:
The first study to focus on the clinical effectiveness of the drug, and therefore performed in patients with the disease. At this stage the studies also determine any short-term side effects and safety risks associated with the investigational drug. (ANAVEX 2-73 HAS DEMONSTRATED SAFETY. THUS FAR, THERE ARE NO SIGNIFICANT SIDE EFFECTS. SOME DIZZINESS HAS OCCURRED WITH SOME PATIENTS, BUT DIZZINESS MAY BE A SIDE EFFECT OF ALL CNS DRUGS. REMEMBER: EVERY DRUGS APPROVED BY THE FDA HAS SOME SIDE EFFECTS! ALL PRESCRIPTION DRUGS HAVE POWERFUL ACTIVE INGRIEDIENTS. THESE INGRIEDIENTS MUST BE POWERFUL IN ORDER TO WORK!)
Phase III:
Studies carried out in large numbers of patients, comparing the investigational drug with the best existing treatment or standard of care in that particular disease. If positive results are obtained all data to date is compiled into a dossier and an application is made to REGULATORY authorities to request a license for clinical use. (THIS IS WHERE EFFICACY WILL BE PROVED OR DISPROVED. IF ANAVEX 2-73 SHOWS ANY EFFICACY AT ALL, IT IS LIKELY TO BE APPROVED BY THE FDA AS DONEPEZIL WAS APPROVED.)
NOTE: One of the several side effects of Donepezil is dizziness! It is dishonest for Adam F, political scientist, to discredit Anavex 2-73 for this side effect.
Phase IV:
Also known as post-marketing studies, these are conducted after the drug is approved by regulatory authorities and may include thousands of patients. These trials are generally designed to evaluate the long-term safety and efficacy of a drug, and to test it in a “real world” setting of daily clinical practice.
(ANAVEX 2-73 MAY MOVE TO THIS PHASE IF IT OBTAINS EARLY APPROVAL SUCH AS BREAK THROUGH THERAPY APPROVAL AS ANAVEX HAS ANNOUNCED THAT IT INTENDS TO PURSUE)
Do your own DD. Decide for yourself. Anavex 2-73 may or may not succeed. Clinical trials are much more complicated than I have outlined above. However, I have gone through the above steps to keep my head straight as we are all confronted by those that attempt to freighten or panic the market for their personal benefit. If I have incorrectly stated anything, please let me know. Any useful comments will be appreciated.
Yes, the science has not changed. The AVXL attacks have not been about the science. On the contrary, the attackers completely avoid discussing the science supporting the therapy. Therefore, I will stick with my plan of accumulating shares at these lower levels.
Yes, I unfortunately have to agree that so far there is no reason to launch any legal action. I have sought some opinions about this as well. However, down the road, there may be a basis. I will be looking for someone to cross the line.
I agree. I like the science. I believe it will eventually prevail. I bought a few more shares this week. I plan to do the same this coming week.
This is some what off subject. The incident in Paris makes us all think. I am saddened by the acts of some vile people in the world, but I have to believe that these people are in the vast minority. The people behind these heinous acts will not succeed in the long run because the vast majority of the world consists of good and decent people, like most people on this message board, that are truly interested in the advancement of mankind -- not the destruction of mankind.
JB: Thank you. I agree.