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I would (and know people that have) travel to Europe for anything that may treat PD or AD, which are diseases due primarily to aging. Old people are not concerned about ED, believe me, they have too much else to be concerned about. I don’t think I would travel to Europe for an ED drug in any event as there are ED drugs approved and on the market everywhere. Moreover, supplements are available for ED. There is no effective drug for AD. The same could be said for PD and other CNL diseases. If AVXL 2-73 is approved for one disease anywhere in the world, people from all over the world will seek to obtain this drug for any CNL disease that is lacking in treatment. And, as Xena points out, EU countries are reforming drug laws and regulations.
CBDpotential is a genius. I believe I remember CBD saying he would take shares under $3.30. Today’s announcement gives options to insiders to purchase shares at $3.30, which means there is no incentive for these insiders to exercise the options unless the share price moves well above $3.30. If so, any purchase under $3.30 will turn out to be brilliant. I hope CBD and the insiders make a killing off their AVXL holdings.
Not really, except the stock price needs to be above $3.30 for these options to benefit the recipients.
Missling stock options at $3.30 per share. Statement of Beneficial Ownership 4 minutes ago.
Yes, great post. Anavex actually made a smart decision on Europe for the Parkinson’s trial as I said in a previous post:
The EU is an excellent choice for the Parkinson's trial. Some of the reasons for saying this are:
1. European Parkinson's experts that have been involved with AVXL 2-73 for several years understand the science behind the drug.
2. They have the credentials and credibility -- at least in Europe.
3. European and (perhaps U.S.) trial participants will be easily recruited.
4. Many more favorable venues for conducting these trials are available in Europe. For example, other young biotech companies have chosen places like the Channel Islands (independent protectrstes of Great Britain) for permission to conduct trials). The result is faster approval of the trials.
5. If success of these trials, and especially any European approval of this drug, will influence the FDA.
6. Any approval of AVXL-273 anywhere in the world will incentive every person and family in the world to seek the drug for these dreaded diseases that AVXL 2-73 may benefit because ALL of these CNS diseases are lacking in treatment.
7. Any approval anywhere will result in faster approval elsewhere.
If I were the CEO of Anavex, I would conduct clinical trials anywhere in the world that may bring this drug to market sooner anywhere in this world. I think Anavex is making a smart move here after a lot of effort and an lot of work to seek the best place possible for the Parkinson's trial. I think the Michael J. Fox Foundation concurs.
The EU is an excellent choice for the Parkinson's trial. Some of the reasons for saying this are:
1. European Parkinson's experts that have been involved with AVXL 2-73 for several years understand the science behind the drug.
2. They have the credentials and credibility -- at least in Europe.
3. European and (perhaps U.S.) trial participants will be easily recruited.
4. Many more favorable venues for conducting these trials are available in Europe. For example, other young biotech companies have chosen places like the Channel Islands (independent protectrstes of Great Britain) for permission to conduct trials). The result is faster approval of the trials.
5. If success of these trials, and especially any European approval of this drug, will influence the FDA.
6. Any approval of AVXL-273 anywhere in the world will incentive every person and family in the world to seek the drug for these dreaded diseases that AVXL 2-73 may benefit because ALL of these CNS diseases are lacking in treatment.
7. Any approval anywhere will result in faster approval elsewhere.
If I were the CEO of Anavex, I would conduct clinical trials anywhere in the world that may bring this drug to market sooner anywhere in this world. I think Anavex is making a smart move here after a lot of effort and an lot of work to seek the best place possible for the Parkinson's trial. I think the Michael J. Fox Foundation concurs.
Happy Holidays to all and to all good night!
Falconer: Thank you.
Adam the odd fellow. I think he mostly cuts and pastes his tweets about small biotech. I have ignored many of his tweets with success.
Jimmy: We are definitely seeing signs of price exhaustion of the down move in price that has occurred since at least October 23. Note the 9 TD sequential count.
The presentation is in the morning at 8:30 a.m. EST before the markets open? How is that negative? The company issued a PR today, and will make a presentation in the morning before the markets open. How can one say that’s negative? Of course, I do not imply that the way it is being arranged is positive either. I do not know. How can anyone interpret this as positive or negative? It seems to me though that it might have rattled some feathers of someone. The share price jumped this initially evening.
Jimmy:
Than you. Excellent response. There are many factors that increase the odds of an FDA approval — especially within the current environment of the Cures Act, FDA changed leadership, Orphan Drug designations, accelerated approval, aging population and diseases or problems that accompany aging. I plan to expound on all this later when time permits.
I do Tom Demark counts and follow some other related services. There are no perfect indicators, but the services I follow are more objective and are more often than not good indicators of up and down moves. These are close to coinciding with the event dates you mention. I am anticipating buy signals this week (Monday - Tuesday through Friday) and possibly into the first of next week (the week of December 11). The counts I do follow some complex rules, and not all trading dates meet the rules as valid days to count. However, this is looking like it either has to be crunch time for a move up if there is going to be one between now and the end of this year. Of course, any move can always breakdown, which is why some traders use stops (mental or otherwise). Basically, I am not a short term trader. I have and am very long term this stock, but I do some shorter trades taking advantage of shorter moves up or down that has helped me to build up my overall “core” position as some on this board day. Hopefully, I will be very right in the long term. I have a high degree of confidence in the science, and I think that what the company is going increases the odds that it may obtain FDA approval for a NEUROLOGICAL INDICATION (note I do not use any specific indication) for AVXL 2-73 along the lines I reasoned in my post yesterday, which is as follows:
The probability that AVXL 2–73 will be approved for treatment of a NEUROLOGICAL DISORDER. That is what I am interested calculating in an OBJECTIVE way.
"Drugs for rare diseases have higher than average approval rates for every stage of the FDA approval process......
For example, 76% of rare disease drugs moved on from phase I trials, compared to 63% of drugs as a whole and 58% of drugs for rare chronic diseases. Similarly, 50% of rare disease drugs moved from phase II to phase III, compared to 30% of drugs overall and 27% of drugs for common chronic conditions. Overall, 25.3% of rare disease drugs successfully completed the full process of review from phase I to approval, compared to 9.6% of drugs overall and 8.7% of drugs for chronic conditions.
The reason for these different rates of approval rates is unclear. It is possible that is simply easier to design effective drugs for rare diseases, many of which are genetic diseases with a single identifiable cause and a clear drug target......
It is also possible that the approval process itself gives greater allowances for drugs designed to treat rare diseases, even if this is not explicit. Under the FDA’s Safety and Innovation Act (FDASIA), the FDA is required to incorporate patient input into their review and decision-making process. The FDA may in practice be more likely to approve a drug with borderline conclusive effectiveness for a rare disease population, as these drug trials often face challenges in getting large numbers of study participants....."
http://www.raredr.com/news/orphan-approval
Yesterday, I did not have time to listen to all that Dr. Gottlieb and Dr. Collins had to say in their testimony. However, I believe I heard them say that emphasis is on faster approval of drugs for rare diseases, Parkinson's, Huntington's, and Alzheimer’s diseases. Further, clinical trial recruitment is made more efficient. The FDA is advancing protocols to enable more coordinated ways the use the same trial structure to evaluate treatments in more than one subtype of a disease or type of patient. The latter approach is relevant when it comes to targeted drugs. These drugs may intervene on markets that are relevant across many disease subtypes. The FDA may want to evaluate these different targets simultaneously. This could give the FDA a better way to understand the comparative benefits of a drug across different settings. The real life patient experience is now taken into consideration when approving a drug, and the Cures Act is helpful in expediting drug approval, etc.
Therefore, I do not think you can rely on historical percentages in estimating approval of a drug and/or the time it may take to approve a drug such as the historical 5% approval rate for Alzheimer clinical trials. Even then, we have 3 clinical trials being designed, one of which has obtained Orphan Status, which I think is important as I discuss below.
I believe Dr. Gottlieb also said that once a drug is approved for one indication, the FDA considers the approval factors for that drug for additional indications that may benefit from the drug.
Neurological disorders were discussed in general, and Dr. Collins mentioned incentives for the development of the treatment of neurological disorders that show some promise.
Adaptive trials are now encouraged by the FDA, which save money on clinical trials (this is me talking here), and the additional incentives that may come along the way help companies continue with trials for rare diseases and for neurological diseases in general. Incentives may be provided by the government, and we also know that incentives are provided by foundations. Therefore, you cannot use historical information to accurately estimate the costs of these clinical trials. All of what I have said makes it more likely today that companies will be able to fund these types of clinical trials like Anavex is doing.
Importantly, if AVXL 2-73 is for a rare disease, you can bet that AVZL 2-73 will be prescribed off label by physicians for neurological diseases, such as Alzheimer’s that do not currently have effective treatment.
I am not knowledgeable about statics, but perhaps someone on this board is. I would like to have an estimate of the odds for approval of AVXL 2-73 for at least one neurological indication as well as an estimate of the probability of how long that approval (or denial of approval) may take. I like to try to look at objective factors and exclude subjective factors, including investor bias. Is there some sort of objective model that may be developed to consider factors like I have discussed above to come up with the probabilities for approval of AVXL for any neurological indication and to estimate the probability of how long the Orphan Drug approval process for AVXL 2-73 may take. Once this is determined (but only then) estimates may later be considered for potential revenues, and probability of profit as well as possibly estimates of share price.
I will end by saying, I understand that my investment is a gamble, but I do not know how the odds compare to a flip of the coin (but no investor ever made a great deal of money without taking risks).
The probability that AVXL 2–73 will be approved for treatment of a NEUROLOGICAL DISORDER. That is what I am interested calculating in an OBJECTIVE way.
"Drugs for rare diseases have higher than average approval rates for every stage of the FDA approval process......
For example, 76% of rare disease drugs moved on from phase I trials, compared to 63% of drugs as a whole and 58% of drugs for rare chronic diseases. Similarly, 50% of rare disease drugs moved from phase II to phase III, compared to 30% of drugs overall and 27% of drugs for common chronic conditions. Overall, 25.3% of rare disease drugs successfully completed the full process of review from phase I to approval, compared to 9.6% of drugs overall and 8.7% of drugs for chronic conditions.
The reason for these different rates of approval rates is unclear. It is possible that is simply easier to design effective drugs for rare diseases, many of which are genetic diseases with a single identifiable cause and a clear drug target......
It is also possible that the approval process itself gives greater allowances for drugs designed to treat rare diseases, even if this is not explicit. Under the FDA’s Safety and Innovation Act (FDASIA), the FDA is required to incorporate patient input into their review and decision-making process. The FDA may in practice be more likely to approve a drug with borderline conclusive effectiveness for a rare disease population, as these drug trials often face challenges in getting large numbers of study participants....."
http://www.raredr.com/news/orphan-approval
Yesterday, I did not have time to listen to all that Dr. Gottlieb and Dr. Collins had to say in their testimony. However, I believe I heard them say that emphasis is on faster approval of drugs for rare diseases, Parkinson's, Huntington's, and Alzheimer’s diseases. Further, clinical trial recruitment is made more efficient. The FDA is advancing protocols to enable more coordinated ways the use the same trial structure to evaluate treatments in more than one subtype of a disease or type of patient. The latter approach is relevant when it comes to targeted drugs. These drugs may intervene on markets that are relevant across many disease subtypes. The FDA may want to evaluate these different targets simultaneously. This could give the FDA a better way to understand the comparative benefits of a drug across different settings. The real life patient experience is now taken into consideration when approving a drug, and the Cures Act is helpful in expediting drug approval, etc.
Therefore, I do not think you can rely on historical percentages in estimating approval of a drug and/or the time it may take to approve a drug such as the historical 5% approval rate for Alzheimer clinical trials. Even then, we have 3 clinical trials being designed, one of which has obtained Orphan Status, which I think is important as I discuss below.
I believe Dr. Gottlieb also said that once a drug is approved for one indication, the FDA considers the approval factors for that drug for additional indications that may benefit from the drug.
Neurological disorders were discussed in general, and Dr. Collins mentioned incentives for the development of the treatment of neurological disorders that show some promise.
Adaptive trials are now encouraged by the FDA, which save money on clinical trials (this is me talking here), and the additional incentives that may come along the way help companies continue with trials for rare diseases and for neurological diseases in general. Incentives may be provided by the government, and we also know that incentives are provided by foundations. Therefore, you cannot use historical information to accurately estimate the costs of these clinical trials. All of what I have said makes it more likely today that companies will be able to fund these types of clinical trials like Anavex is doing.
Importantly, if AVXL 2-73 is for a rare disease, you can bet that AVZL 2-73 will be prescribed off label by physicians for neurological diseases, such as Alzheimer’s that do not currently have effective treatment.
I am not knowledgeable about statics, but perhaps someone on this board is. I would like to have an estimate of the odds for approval of AVXL 2-73 for at least one neurological indication as well as an estimate of the probability of how long that approval (or denial of approval) may take. I like to try to look at objective factors and exclude subjective factors, including investor bias. Is there some sort of objective model that may be developed to consider factors like I have discussed above to come up with the probabilities for approval of AVXL for any neurological indication and to estimate the probability of how long the Orphan Drug approval process for AVXL 2-73 may take. Once this is determined (but only then) estimates may later be considered for potential revenues, and probability of profit as well as possibly estimates of share price.
I will end by saying, I understand that my investment is a gamble, but I do not know how the odds compare to a flip of the coin.
In dealing with any government agency, I have found that nothing ever happens as quickly as one in the private sector is prone to expect. I expect the FDA, although some what better now with the new director and Cures Act,etc., is part of the problem in slowing these trials down.
By the way, I listened to as much of Gottlieb and Collins testimony as I could today. From what I heard, it confirmed what Anavex has said about its trial designs regarding markers, real life experiences of patients, precision medicine, etc. I didn’t have time to listen to it all. Rare disease priority was mentioned as well as Alzheimer’s, cancers, and Parkinson’s as being the focus of the Cures Act.
By the way, I am appreciative that you are in the industry and following this stock.
Thank you. You may be right about that. I suppose the company is being overly cautious because they have been sued once. I guess this small company is gun shy, since I do not know of any good reason to speculate otherwise.
It seems Reg. FD actually led to less disclosure as institutional investors argued when they opposed Reg. FD. Therefore, we must all be content to wait and receive press releases about when the various trials will commence. For that matter, we must wait for press releases for any and all material information. We cannot send an email to PR and expect to receive material information in that email. The disclosure must be made to the public all at the same time, which is usually in the form of a press release. I am satisfied to wait for the press release. Here is what Wikipedia says about the regulation:
Regulation Fair Disclosure
Regulation Fair Disclosure,[1] also commonly referred to as Regulation FD or Reg FD, is a regulation that was promulgated by the U.S. Securities and Exchange Commission (SEC) in August 2000.[2] The rule mandates that all publicly traded companies must disclose material information to all investors at the same time.
The regulation sought to stamp out selective disclosure, in which some investors (often large institutional investors) received market moving information before others (often smaller, individual investors).
Regulation FD fundamentally changed how companies communicate with investors by bringing more transparency and more frequent and timely communications, perhaps more than any other regulation in the history of the SEC.
On April 2, 2013, the Securities and Exchange Commission said companies can use social media to disseminate information if certain requirements are met. As with company websites, investors’ access to the chosen social media platform must not be restricted and investors must be notified about which social media will be used to disseminate information.[3]
Most corporate announcements are issued via press releases or conference calls and then summarized on websites.
Background Edit
Before the 1990s, most individual investors followed the progress of their stock holdings by receiving phone calls from their broker, by reading annual or quarterly reports mailed to them by the company, by reading news in newspapers or financial publications, or by calling the company with questions. Most investors relied primarily upon full service brokers, such as Merrill Lynch, for trading advice.
During the 1990s, Internet usage became widespread and online discount brokers such as Charles Schwab, E-Trade and Ameritrade allowed individual investors to trade stocks online at the push of a button. At the same time, these investors began using the Internet to research stocks and make timely, more informed trading decisions. The Internet placed a plethora of rich research information into the hands of investors, who became more empowered than ever to make their own informed investing decisions. As these investors learned the joys of real-time stock quotes and near-real-time access to press releases, they began to demand even more access.
By 1999, individual investors became more aware of quarterly analyst conference calls, where a company's management would disclose the results of the quarter and answer analyst questions about the company's past performance and future prospects. At the time, most companies did not allow small investors to attend their calls.
One small investor, Mark Coker, founded a company called Bestcalls.com, a directory of conference calls open to all investors, to help persuade public companies to open up all their calls ([1] and [2]). Coker campaigned in the press to educate individual investors about the benefits of conference call attendance as a fundamental research tool, and worked constructively with the SEC to educate them about the pervasiveness of selective disclosure on earnings conference calls. At the same time, companies such as Onstream Media, Broadcast.com, Vcall.com, Shareholder.com and Thomson Financial (now Thomson Reuters) offered webcasting technology and services that made it more practical, and more affordable, for companies to allow all investors to listen in.
In December 1999, the SEC proposed Regulation FD. Thousands of individual investors wrote the SEC and voiced their support for the regulation. But support was not unanimous. Large institutional investors, accustomed to benefiting from selectively disclosed material information, fought vigorously against the proposed regulation. They argued that fair disclosure would lead to less disclosure. In October 2000, the SEC ratified Regulation FD.
Those are good points. In addition, there’s a number of people participating in the various trials as patients with the backing of legitimate organizations, two foundations in fact. Decisions for patients and organizations to participate in trials are not made in a vacuum. Eighteen years ago, I participated in a clinical trial for a gene therapy to treat cancer. The decision to do that was well researched by me, and I also consulted with physicians that I thought had expertise. Additionally, physicians at various clinical sites must also make decisions to participate. My point is that decisions to participate by patients and care givers are not made lightly. These illnesses are serious. The fact that a clinical trial is successfully put together by recruiting patients and care givers sends messages of hope if not some amount of legitimacy. All of those participating are “gambling” so to speak that this molecule may be of some benefit when all else failed. All of this lends some amount of credibility that may lead to speculation that the molecule is worth risking a bit of an investors capital as well. Notice that some institutions and hedge funds are even stepping forward and buying relatively small amounts of AVXL shares thinking that there may be something to this particular molecule. “Let’s at least place a bet”, I suppose falls in the category of human psychology for participants and investors.
I am curious about the below part of the article that states that 9 out of 24 patients with full data improved, but 6 had the best response. Plus, if I am reading this correctly, 1 patient remained stable. It seems then that 10 out of 24 patients with full data benefited at least to some extent. However, what about the ones that declined is one question that I have. In other words, I am curious about the degree of decline among the 14 patients that declined. Was their rate of decline less (a benefit), the same (no benefit), or more (a detriment) than the normal rate of decline of Alzheimer’s patients in general? See this part of the article:
“Dr. Afshar presented 57-week data for the 26 patients who were still in the trial at that point and 109-week data for the six patients who had the best response at 57 weeks. Patients in both analyses were grouped by plasma level, not by their dosage level, although Dr. Missling said higher dosage generally correlated with higher plasma levels.
At 57 weeks, six patients had improved on the MMSE: four with high plasma levels and two with low plasma levels – patients identified as “outliers.” One patient with a high level remained stable. The rest of the cohort declined: seven with low levels, eight with moderate levels, and four with high levels, who were also identified as outliers. Also at 57 weeks, 24 patients had full data on the functional measure, the Alzheimer’s Disease Cooperative Study-Activities of Daily Living (ADCS-ADL). Nine patients had improved: five with high plasma levels, three with moderate levels, and one with a low level, identified as an outlier. One patient, with a moderate level, remained stable. The remaining 14 patients declined: nine with moderate levels, four with low levels, and one with a high level, dubbed an outlier.”
Biostockclub: What you say makes sense to me, and based on my long life I believe as well that taking what we see at face value is indeed how life works.
“The Walt Disney Company share gained (while NFLX fell) after the company said it plans to price its streaming service "substantially below" that of Netflix. The company said, however, that its service will be cheaper because it will initially have a smaller library than what the streaming giant offers. Disney said its goal is to attract as many subscribers as possible when it launches the service.”
The above is one example of competition Netflix faces next year while content producers demand higher prices from NFLX. Add to that coming increases in interest rates. Check out the likelihood of another,Fed interest rate hike in December. Add to all that the effect of the passage of a tax stimulus bill this late in the long economic recovery from the 2008 crisis. It's not the time to stimulate the economy (when it is coming out of the recovery) because that produces more inflation that the Fed is focused on containing with the interest rate increases. NFLX's strategy is based on borrowing more money to buy more content, etc. Low interest rates helped Netflix to do borrow, but it has too much debt now from from doing that. That cycle is not forever sustainable. All that borrowing has been fun for NFLX and its shareholders, but paying it back this late in the game with increased competition will be extremely painful.
Not looking good. I don’t like the chart. Take note of the PMO sell signal, MACD and Stochastic headed down, plus read the latest news this evening where the Chief Financial Officer dumped some stock shares very quickly and timely I think. Good for the CFO that has the very best insider’s perspective of Netflix, but bad for lesser hopeful morsels holding the stock. And, no, I think prospects for this stock heading higher next year are very unlikely viewing the fundamentals and late stage of the bull market rally that has taken share value to the extreme. Be careful and good luck.
Great! I will continue to hold my long lasting long position and accumulate as I did again today. I have no need to sell. I have a strong cash position to continue accumulating. I have made a lot of money off this stock from selling and buying from time to time, and I am thankful for another opportunity to add more shares for the long term. Although I have successfully bought and sold over the past several years, my interest all along has been to gradually increase my long term core holdings. Thanks to whomever for yet another buying opportunity.
Note this about the focus of CTAD 2017:
''The future of clinical trials may lie in revisiting all drugs known to be safe and evaluate their relevance in AD treatment. .....
CTAD 2017 will highlight the latest on trying to get these trials off the ground.
Overall, the aim of the conference is to overcome the hurdles and speed the development of effective treatments.''
Paul Aisen (Anavex expert board) was one of the major figures at the CATD 2017 conference.
I like the overall aim ''... to overcome the hurdles and speed the development of effective treatments.'' Everyone, including the FDA is onboard with doing just that.
I am cautiously optimistic.
Yes. The AVXL information presented at CATD 2017 is helpful to design the AVXL 2-73 clinical trial going forward. Ariana was hired to focus on the best responders, which it seems are those with mild Alzheimer's. If a statistically significant number of mild Alzheimer's patients respond to treatment in the next phase, the drug will be approved. If it is approved, AVXL 2-73 will be prescribed, perhaps off label, for all Alzheimer's patients if it is perceived to improve sleep and mood. Sleep and mood is a major problem in Alzheimer's patients. I say all of this too because there is not much of anything currently available to treat Alzheimer's patients. No one at this point knows whether future mild Alzheimer's patients will respond positively or negatively compared to a placebo. Therefore, anyone that professes to predict one way or another is simply guessing. I am very long -- have been for a long time. I hope AVXL 2-73 is a success.
There’s something about that 47.15 - 47.13 price level — pull back on the daily chart.
Consider NFLX has decided to get into content. Disney produces content. Disney has a P/E ratio of under 18. What differentiates NFLX from other content producers to support or justify a P/E ratio of 281?
More accurately, a melt up.
My understanding is that a primary reason Ariana was hired was to focus on the best responders. Specifically, AVXL is supposedly identifying the best responders to ANAVEX2-73 by using Ariana Pharma’s KEM advanced Artificial Intelligence technology. This analysis is planned to be used to more effectively design the upcoming Phase 2/3 clinical study, potentially raising the odds of late stage trial success. Is it possible to use this analysis to improve responses in other/more patients going forward?
In looking at a Demark chart and considering how this stock has moved over the years I have followed it, AVXL shares are likely to zigzag or wallow at this lower level for at least the next 6 trading days, which coincides with the CTAD as well. Of course if positive and convincing information is revealed at the CTAD, the stock should move up sharply. If the latter information is clearly negative, there will obviously be a sharper move down. In the meantime, I do not expect the stock to do much of anything. Lastly, based on my studies of this drug candidate, I am in the hopeful camp that we will get reliable and positive news, but I will manage my expectations waiting patiently to know more come the first part of November. I am actually writing this for myself to do just that … to help manage expectations and exercise patience.
With limited time lately, I briefly looked for the presentation, but I couldn’t find it. If I find something I will post it.
Galectin Therapeutics to Present Clinical Data at The Liver Meeting® 2017 Demonstrating the Ability of Non-Invasive Test to Identify Clinically Significant Portal Hypertension in Patients with Compensated NASH Cirrhosis
The study will be presented at The Liver Meeting® in Washington D.C. on October 19-23, 2017 and is co-authored by investigators involved in the NASH-CX trial. Topline results from the trial will be reported in December, 2017.
http://globenewswire.com/news-release/2017/10/20/1150936/0/en/Galectin-Therapeutics-to-Present-Clinical-Data-at-The-Liver-Meeting-2017-Demonstrating-the-Ability-of-Non-Invasive-Test-to-Identify-Clinically-Significant-Portal-Hypertension-in-Pa.html
Surely, that’s a tongue in cheek statement. There are no new eras in the markets although this bull market has historically been ongoing for a long time.
I do, however, congratulate all of the longs. They are doing extremely well for now.
For me, I will not presently invest any money in NFLX although I have done so before.
I may be out early, but the worm can turn at any point. I have experienced major market drops before. In 1967, I bought an S&P put for $750 based on a Paul Tudor Jones prediction of a correction. The next week the crash came. I called my broker after hearing about the drop. I was stunned. The put was quoted at $87,000.00. I thought the financial world was coming to an end. It did not, but then there was 1990, 2008, etc.
What benefit need be shown for FDA approval of an Alzheimer's drug? Can Anavex show a statistically meaningful benefit for (a) cognition and/or (b) function?
See this article for a discussion of statistically meaningful benefits of endpoints for FDA approval of an Alzheimer's drug: http://www.usagainstalzheimers.org/sites/all/themes/alzheimers_networks/files/Researchers-Against-Alzheimer%27s-Endpoints-Analysis-FINAL-5-10-17.pdf
Here are some excerpts:
''The Food and Drug Administration’s (FDA) approach to approving new medicines for Alzheimer’s disease since the 1990s has been to require a proven benefit on two independent primary endpoints of cognition and function, although this policy has not been formalized in the FDA rules or finalized FDA guidance. We argue that, in light of an improved scientific understanding of the continuous and progressive character of the disease and consistent with many recent oral expressions by agency leadership in public settings, the FDA should clarify for the field that a clinically meaningful benefit on a single primary endpoint of cognition or function is a sufficient basis for a New Drug Application filing.
.....we would note that even if the FDA may be open to approving a safe and well-tolerated drug that demonstrates efficacy on a single primary endpoint of cognition or function,22 the agency might naturally wait for such a drug to be presented to the agency before articulating this position. We would strongly disagree with such an approach. If the FDA were to state that meaningful efficacy on a single endpoint is sufficient for approval, we believe that it would impact prospective investments in this therapeutic area as well as clinical trial design, including considerations of power and sample size, and possibly even reducing the costs and burden of trials to some degree.
18 Hong Liu-Seifert et al., “Function and clinical meaningfulness of treatments for mild Alzheimer's disease,” Alzheimers Dement (Amst), March 2016, p. 105–112, https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4879645/ (internal footnote omitted).
See also footnotes 21 and 22:
21 There is an argument that the practice of classifying endpoints in terms of cognition and function is itself in need of conceptual re-examination. To a patient, a memory loss (cognition) that prevents normal social engagement or reading comprehension (function) could be viewed as either or both a cognitive endpoint or a functional endpoint. Regarding function as meaningful and cognition as not meaningful doesn’t make sense from a patient’s perspective. From a patient’s perspective, the critical inquiry is whether a drug candidate has a truly ‘clinically meaningful’ impact on an endpoint that matters to him or her, whether classified as cognition or function. A full explication of this argument is beyond the scope of this paper.
22 We recognize that with advances in our understanding of Alzheimer’s disease and other dementias, the categories of “cognition” and “function” have become less rigid and more confusing, as it has become increasingly clear that cognition is a surrogate for function, although not a substitute for it.''
I signed the petition.
NFLX completes a double top 2 days ago.
''Netflix shares appear to be reflecting this changing growth, cost and risk profile. The shares recently failed to break through $190.00, completing a double top short of the $200.00 round number. The shares have dropped back to test their 50-day average near $178.00. The relative strength index (RSI) is testing 50, where a break would signal a downturn in momentum. The next potential downside support levels appear near $169.55, a 23% retracement? of the current uptrend, then $163.90, the bottom of a previous breakaway gap and a support level established through August.''
Read more: Netflix Stock Completes Double Top | Investopedia http://www.investopedia.com/news/netflix-stock-completes-double-top/#ixzz4u2303LOo
Netflix falls after FX+ expands
Sep. 25, 2017 4:06 PM ET|By: Clark Schultz, SA News Editor
Netflix (NASDAQ:NFLX) fell 4.70% after FX Networks announces that its FX+ streaming service will be included on Cox Communications in October. FX worked a deal with Comcast earlier in the month.
FX+ costs consumers $5.99 per month for no-ad on-demand access to 16 FX series past and present.
The move fired off by FX parent Fox shows that Netflix may have more trouble landing licensed content and helps explain its larger push into original content.
What will Anavex present Tuesday of next week. Anavex Life Sciences to Present at the Ladenburg Thalmann 2017 Healthcare Conference
Howard Marks, after being criticized about some of his statements about the market, valuations, etc. , said this:
"FAANGs
There’s been a lot of discussion regarding my comments on the FAANGs – Facebook, Amazon, Apple, Netflix and Google – and whether they’re a “sell.” Some of them are trading at p/e ratios that are just on the high side of average, while others, sporting triple-digit p/e’s, are clearly being valued more on hoped-for growth than on their current performance.
But whether these stocks should be sold, held or bought was never my concern. As I said on Bloomberg:
My point about the FAANGs was not that they are bad investments individually, or that they are overvalued. It was that the anointment of one group of super-stocks is indicative of a bull market. You can’t have a group treated like the FAANGs have been treated in a cautious, pessimistic, sober market. So that should not be read as a complaint about that group, but rather indicative [of the state of the market].
That’s everything I have to say on the subject."
Absolutely!