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Following up, it would be a big problem if the company kept saying positive things about the drug if it is not certain -- if the trial results is ambiguous.
I, too, am not a securities lawyer. However, my lay understanding is that this company, as any company, must disclose a material fact. If Anavex knows the Alzheimer's clinical trial results are negative, that's a material fact, and there is a duty to disclose that. However, if there is ambiguous information about the trial, which the company is still studying, I do not believe that has to be disclosed. Lastly, I believe though that it would be a mistake for the CEO to continue to purchase shares, even in small in amounts, if the CEO knows there may be negative information about the clinical trial because that may be alleged to be misleading -- leading investors to think that all is well when all is not well if the trial may be doubtful about whether the drug works.
After reading today's, September 6, Statement of Changes in Beneficial Ownership wherein a director, Richard N. Barton, sold shares as soon as received, I checked further insider transactions of NFLX. Insiders are not net buyers of NFLX's stock.
If AVXL 2-73 promotes neuroplasticity, it may benefit stroke victims or patients that have dyslexia, among other medical problems. Of course, we have a long way to go to prove that and obtain approval for all these various indications.
''Although the exact function of the MeCP2 protein is unclear, it is likely involved in maintaining connections (synapses) between nerve cells (neurons)''
https://ghr.nlm.nih.gov/condition/rett-syndrome
Will AVXL 2-73 help to maintain connections between nerve cells?
See Barron's this weekend article "The Crowded Trades of a Scary September."
It is overbought, and I expect it to sell off today.
As one market commentator said tonight: "Maybe we'll get another bounce next week, or maybe the decline will continue, but expanding New Lows make me think that a rally to new, all-time highs is not in the cards." Maybe so. Maybe not. Who knows.
Buy the fear! It takes courage, but it is an excellent strategy. Sell the euphoria, which does not apply to AVXL. However, it applies to the stocks generally... that is maybe until today or sometime before too long.
At this juncture, this is could apply to buyers or sellers of NFLX. ''Fools rush in where angels fear to tread.'' My choice is to not own, buy or sell this stock. In any event, the cardinal rule is never fall in love with any stock.
A significant price move today and some other small, encouraging signs are appearing. On a daily basis, money, accumulation, RSI, MACD, STO and other indicators are turning up after a descent from June 7 through August 9. Some insider buying is taking place.
It was a steep drop from $6.27 on June 7 to a low of $3.33 on August 9, approximately 50% down for that time frame. After hours today, a few shares traded at $4.14. That is a gain of almost 25% from the August 9 low of $3.33.
I do not know where we go next, but suddenly it is looking better. Seasonally, September has been a good month for the company usually with more news events. We saw some increased volume on a significant down move on July 21. After that volume somewhat declined until the low on August 9, which was a tad up. Volume on this up move today was decent, over 531,000 compared to average volume of over 320,000.
We will have to wait and see, but for now, there are more buyers than sellers after more than a month of selling.
Barron's article this weekend. ''The Trouble With Netflix --
As Disney goes its own way and Amazon looms, shares could drop more than 50%.''
I recall that a few years back, Missling made several purchases of a thousand shares every now and then. People on this board at the time speculated he was sending a signal. Who knows? By itself, this is not significant when you consider only the dollar value of the 750 shares amounting to $2,600 and some change. However, I cannot envision why someone of his intelligence would on a whim throw away $2,600 for no reason at all. Let's see what he does from here. His salary, despite what some may say, is not very high for a N. Y. City life style. It takes a lot of money (more than his salary) to live comfortably in N. Y. He probably does not have a lot of cash to spare, but his great fortune may eventually come from this company. It may be a willingness to put everything he has in this company. It may seem odd, but it is definitely not a bad thing.
Smart move so far. Check NFLX and AMZN after hours this evening, August 8.
StockCharts.com has a feature where one may view the seasonality of stocks or commodities. I viewed the seasonality for Anavex. It shows the percentage of months in which Anavex closed higher than it opened. July seems to be the worst month for Anavex. August improves a bit, but September is one of the strong months. This meshes with what I have experienced during the time I have owned Anavex shares. This seasonality may have something to do with the work habits of Missling and his small staff. The company seems to be more active in the September - June time frame. Therefore, I speculate that the PRs or news should resume frequency beginning in September if not in August. Mere conjecture of course.
Thank you. I try to be honest. I am mostly writing to myself because that is sometimes how I think through things. Of course, I realize that I am sometimes wrong although I try to be diligent. I may be premature, but it pays to be cautious at this point I think.
I try to think slowly. CNBC, NBC, Fox or whatever must tell their stories in bites that appeal to a broad audience. Don't get me wrong; they provide an excellent service. I am just saying though that they can only scratch the surface. Here's an example, the latest employment report. If you dig below the surface, it is not that great.
The unemployment rate reported doesn't include people who have stopped looking for work. Moreover, it counts part-time workers as fully employed. A broader measure of unemployment (U-6) includes people unemployed or underemployed and currently sits at 8.6%, which is twice as high as the number in focus. This suggests that we're nowhere close to real full employment as does the percent of workers participating in the work force. I think this is one reason why wages aren't rising faster in the face of the so-called near full employment.
There are many problems we face when we analyze this aging bull market.
That said, you may see more thrusts upward in equity prices, but, again, where is the top. There is always a top. There is always a bottom. Most investors buy at the top and sell at the bottom. I try to sell near the top (no one can forecast a precise top) and buy near the bottom (no one knows an exact bottom). It is not easy, and I sometimes fail. However, I would rather come up a little short than to lose by a wide margin.
Lastly, I respect others, and I do not intend to offend anyone. As I said, I write mostly for my benefit. Whatever, I publish is what I conclude from always staying on top of my investments of funds gained from a long life of hard work. Others, I am sure are smarter than I am, and they can rightly decide for themselves what is best for them.
Insider buying.
Pulse Biosciences, Inc (NASDAQ:PLSE) Director Maky Zanganeh acquired 28,790 shares of the business's stock in a transaction dated Thursday, August 3rd. The shares were bought at an average price of $23.96 per share, for a total transaction of $689,808.40. Following the completion of the acquisition, the director now owns 287,225 shares in the company, valued at $6,881,911. The acquisition was disclosed in a legal filing with the SEC.
Director Maky Zanganeh bought 8,290 shares of Pulse Biosciences stock in a transaction dated Wednesday, August 2nd.
Pulse Biosciences, Inc (NASDAQ:PLSE) major shareholder Robert W. Duggan acquired 277,450 shares of Pulse Biosciences stock in a transaction on Thursday, August 3rd. The stock was acquired at an average price of $23.14 per share, with a total value of $6,420,193.00. Following the purchase, the insider now directly owns 3,153,234 shares in the company, valued at $72,965,834.76. The transaction was disclosed in a document filed with the Securities & Exchange Commission, which is available through the SEC website. Major shareholders that own at least 10% of a company's stock are required to disclose their transactions with the SEC.
Insider buying.
Pulse Biosciences, Inc (NASDAQ:PLSE) Director Maky Zanganeh acquired 28,790 shares of the business's stock in a transaction dated Thursday, August 3rd. The shares were bought at an average price of $23.96 per share, for a total transaction of $689,808.40. Following the completion of the acquisition, the director now owns 287,225 shares in the company, valued at $6,881,911. The acquisition was disclosed in a legal filing with the SEC.
Director Maky Zanganeh bought 8,290 shares of Pulse Biosciences stock in a transaction dated Wednesday, August 2nd.
Pulse Biosciences, Inc (NASDAQ:PLSE) major shareholder Robert W. Duggan acquired 277,450 shares of Pulse Biosciences stock in a transaction on Thursday, August 3rd. The stock was acquired at an average price of $23.14 per share, with a total value of $6,420,193.00. Following the purchase, the insider now directly owns 3,153,234 shares in the company, valued at $72,965,834.76. The transaction was disclosed in a document filed with the Securities & Exchange Commission, which is available through the SEC website. Major shareholders that own at least 10% of a company's stock are required to disclose their transactions with the SEC.
Martin Shkreli convicted today of securities fraud. He caused those of us on this board a bit of grief in the past.
Cracks are appearing that effect NFLX, and the stock market in general.
Apple added 49 points to the Dow's 52 point advance August 2nd to push the Dow to a new record. This new Dow record does not have that much support when you consider all of the divergence occuring in the markets. The NASDAQ has been diverging from the Dow. What's more, there is divergence between the Dow and the broader market.
The Dow is deceiving at times. It has been dominantly influnced lateley by a few companies like Boeing, Apple, Verizon, etc. Boeing which has gained 20% over the last month; Verizon's nearly 10% gain over the last week; and Apple's nearly 5% gain today. As John Murphy said: "While that's good for the Dow, history suggests it's not necessarily good for the rest of the market. That's because Dow leaderhship has usually been more a sign of caution than confidence. The Dow Jones Industrial Average is composed of thirty of the bluest of blue chip stocks. That's where investors go when they're looking for more safety. They buy lesser quality stocks when they're more optimistic. Right now, they're favoring the blue chips.''
ISM Non-manufacturing Index has been declining and is flagging a deceleration of economic pace, and there are many more signs that all is not well even though the Dow's advances make headline news.
There are times when the Dow's leadership is not good for the market as a whole. This is a time when the Dow is not representing the broader market. History repeats itself. The broader market is diverging from the Dow. Late in the bull markets, you see the Dow advancing when most of the market is weak. You should study the broader market, and look for potential cracks in the market. Most investors do not do that. The broader market does not look great. However, to most investors, I admit that everything looks great to them judging mostly by new record highs in the Dow. There is always a top in a bull market, and everything always looks good to most investors at the top. I do not know when we will top out, but I am afraid we are getting dangerously close. To me, this market does not have legs!
Remember Bob Farrell's 10 rules of investing:
1. Markets tend to return to the mean over time.
2. Excesses in one direction will lead to an opposite excess in the other direction.
3. There are no new eras—excesses are never permanent.
4. Exponential rapidly rising or falling markets usually go further than you think, but they do not correct by going sideways.
5. The public buys most at the top and the least at the bottom.
6. Fear and greed are stronger than long-term resolve.
7. Markets are strongest when they are broad and weakest when they narrow to a handful of blue-chip names.
8. Bear markets have three stages: sharp down, reflexive rebound, and a drawn-out fundamental downtrend.
9. When all the experts and forecasts agree, something else is going to happen.
10. Bull markets are more fun than bear markets.
Selling is emerging. The chart looks negative.
Maybe, you are not quite on base because this is not the full picture regarding exclusivity. Drug exclusivity is more complex. Besides patent exclusivity, generally there are other forms of exclusivity. Definitely, at the very least, you need to know these forms of exclusivity:
1. Orphan Drug Exclusivity (ODE) - 7 years: • Granted to drugs designated and approved to treat diseases or conditions affecting fewer than 200,000 in the U.S. (or more than 200,000 and no hope of recovering costs) • Runs from time of approval of NDA or BLA • Bars FDA from approving any other application (ANDA, 505(b)(2) or “full” NDA or BLA) for the same drug for thesame orphan disease or condition for seven years • Covered under the Orphan Drug Act and 21 CFR 316.31
2. New Chemical Exclusivity (NCE) - 5 years: • Granted to a drug that contains no active moiety that has been approved by FDA under section 505(b) • Runs from time of NDA approval • Bars FDA from accepting for review any ANDA or 505(b)(2) application for a drug containing the same active moiety for: - five years if an ANDA or 505(b)(2) does not contain a paragraph IV certification to a listed patent - four years if an ANDA or 505(b)(2) is submitted containing a paragraph IV certification to a listed patent • Described in 21 CFR 314.108
3. "Other" Exclusivity - 3 years for a "change" if criteria are met: • Granted to drug when application or supplement contains reports of new clinical investigations (not bioavailability studies) conducted or sponsored by applicant and essential for approval • Runs from time of NDA approval • Bars FDA from approving, for a three year period, any ANDA or 505(b)(2) application that relies on the information supporting the approval of the drug or the change to the drug for which the information was submitted and the exclusivity granted • Described in 21 CFR 314.108
4. Pediatric Exclusivity (PED) - 6 months added to existing Patents/Exclusivity • Grants an additional 6 months of market protection at the end of listed patents and/or exclusivity for sponsor’s drug products containing the active moiety, when the sponsor has conducted and submitted pediatric studies on the active moiety in response to a Written Request from FDA • Pediatric exclusivity takes on characteristics of five year, three year or orphan exclusivity when it attaches to those protections. • Described in the Best Pharmaceuticals for Children Act (BCPA) and Section 505(A) of the Food and Drug Administration Modernization Act of 1997.
Maybe, you are not quite on base because this is nit the full picture regarding exclusivity. Drug exclusivity is more complex. Besides patent exclusivity, generally there are other forms of exclusivity. Definitely, at the very least, you need to know these forms of exclusivity:
1. Orphan Drug Exclusivity (ODE) - 7 years:
• Granted to drugs designated and approved to treat diseases or conditions affecting fewer than 200,000 in the U.S. (or
more than 200,000 and no hope of recovering costs)
• Runs from time of approval of NDA or BLA
• Bars FDA from approving any other application (ANDA, 505(b)(2) or “full” NDA or BLA) for the same drug for thesame orphan disease or condition for seven years
• Covered under the Orphan Drug Act and 21 CFR 316.31
2. New Chemical Exclusivity (NCE) - 5 years:
• Granted to a drug that contains no active moiety that has been approved by FDA under section 505(b)
• Runs from time of NDA approval
• Bars FDA from accepting for review any ANDA or 505(b)(2) application for a drug containing the same active moiety for:
- five years if an ANDA or 505(b)(2) does not contain a paragraph IV certification to a listed patent
- four years if an ANDA or 505(b)(2) is submitted containing a paragraph IV certification to a listed patent
• Described in 21 CFR 314.108
3. "Other" Exclusivity - 3 years for a "change" if criteria are met:
• Granted to drug when application or supplement contains reports of new clinical investigations (not bioavailability
studies) conducted or sponsored by applicant and essential for approval
• Runs from time of NDA approval
• Bars FDA from approving, for a three year period, any ANDA or 505(b)(2) application that relies on the information supporting the approval of the drug or the change to the drug for which the information was submitted and the exclusivity granted
• Described in 21 CFR 314.108
4. Pediatric Exclusivity (PED) - 6 months added to existing Patents/Exclusivity
• Grants an additional 6 months of market protection at the end of listed patents and/or exclusivity for sponsor’s drug products containing the active moiety, when the sponsor has conducted and submitted pediatric studies on the active moiety in response to a Written Request from FDA
• Pediatric exclusivity takes on characteristics of five year, three year or orphan exclusivity when it attaches to those protections.
• Described in the Best Pharmaceuticals for Children Act (BCPA) and Section 505(A) of the Food and Drug Administration Modernization Act of 1997.
Look at the chart. PMO, ADX, MFI, ChiOsc, and MACD all pointing down. The path of least resistance is down. Plus, late July -- early August is seasonally a weak period. Add to all that Howard Marks warning about FANGs. Additionally, the North Korean situation must be dealt with. The diplomat solution failed. It's time to be cautious.
Oaktree Capital’s Howard Marks is sending a warning to markets.
In his latest investing memo to clients, Marks — one of the most widely-read and respected investing pros out there — strikes an extremely cautious tone and recalls two memos he published in years most investors would like to forget: 2000 and 2007.
Those memos cautioned on the excesses of the tech boom and housing markets, respectively.
“Since I’m convinced ‘they’ are at it again — engaging in willing risk-taking, funding risky deals and creating risky market conditions — it’s time for yet another cautionary memo,” Marks writes.
“Too soon? I hope so; we’d rather make money for our clients in the next year or two than see the kind of bust that gives rise to bargains… Since we never know when risky behavior will bring on a market correction, I’m going to issue a warning today rather than wait until one is upon us.”
In his memo, Marks outlines what he calls the seeds for a boom, which include things like more money than ideas (the current bull market is often attributed to a surge in liquidity), willing suspension of disbelief among investors (“this time is different“), and pursuit of the new (think FAANG), among others.
And it is this final idea, and the FAANG stocks, that perhaps sends the clearest warning to investors that they ignore history — and fairly recent history at that — at their own peril.
You are correct. I checked both the daily and weekly charts. In July 2016 (July 27, 2016) as an example when we had a big down move (larger than this down move yesterday, July 21), we had news that was interpreted as negative and greater volume. Yesterday's move down occurred with no news and lower volume than previous big down moves. The daily down move yesterday went from a low of 3.63 to close at 4.21, almost 50% up from the low of the day. Perhaps yesterday's selling lacks the conviction of previous larger down moves that happened in November 2015 and July 2016. We will have to see if there is follow through selling. However, I do not know of any reason to sell. Might there be some negative news passed on by insiders that we do not know yet? From all that I/we know, it seems that the latter is not likely. It seems more likely that someone took advantage of the long lapse in no news to drive the share price down.
We have seen big down moves in the past. Look at 2015 and 2016 as examples. Actually, this down move today is smaller than previously large down moves that occurred in November 2015 and July 2016. It's too bad some longs may have panicked and sold today. It was a bit nerve racking with the way the price was moving down. It was not easy for me to do, but I bought quite a bit today with an average of $4.15 per share. I have profitably bought and sold over the years always maintaining a core position, and I now own more shares than I have ever owned. Of course, only time will tell whether I have once again made the right move. However, I do not know of any reason to be overly concerned.
For anyone interested, here's Bob Farrell's 10 rules of investing:
1. Markets tend to return to the mean over time.
2. Excesses in one direction will lead to an opposite excess in the other direction.
3. There are no new eras—excesses are never permanent.
4. Exponential rapidly rising or falling markets usually go further than you think, but they do not correct by going sideways.
5. The public buys most at the top and the least at the bottom.
6. Fear and greed are stronger than long-term resolve.
7. Markets are strongest when they are broad and weakest when they narrow to a handful of blue-chip names.
8. Bear markets have three stages: sharp down, reflexive rebound, and a drawn-out fundamental downtrend.
9. When all the experts and forecasts agree, something else is going to happen.
10. Bull markets are more fun than bear markets.
Yes, why? Expected quarterly earnings were 16 cents. Earnings failed expectations. Quarterly earnings were 15 cents! By the way, take a look at the PE ratio, although I know that's old fashioned consideration. The PE ratio is in outer space. What caused the surge was the subscriber base increased, but that subscriber base is fickle. You could see it suddenly fade away at some point. What has worked in the past, especially during a favorable market spurred on by QE, may not necessarily work in the future. QE has ended and the FED will be reducing the 4.3 trillion or so balance sheet as it has announced. Nothing goes on forever. However, if one thinks that is not the case and that what once works will always work, so be it. By the way, what ever happened to Blockbuster? Competition from Netflix and others put an end to the Blockbuster phase. Another time another story, and think about competition from the likes of Amazon now as well as new competition in the future. There is nothing more inviting to competition than success. Netflix has experienced great success, but success breeds competition. Nothing is constant except change and change continues as time marches on.
There's some decent buying after hours. It's a Friday. It's a bit unusual for Anavex at least. It may not mean much of anything, but I find it somewhat unusual for this stock.
Correction: It is a 4 day conference from June 6-9.
This is not a conference for small, retail investors. "This global gathering of leading executives, institutional investors, private equity investors and VCs will address near- and long-term investment opportunities and discuss the mechanisms driving healthcare in the U.S. and internationally.
350 companies and 2500 people may be attending, but there are small breakout sessions. Anavex is presenting on the last day of this 3 day conference. My guess is its presentation will be a small session. It's a significant conference, but I would not say Anavex's presentation will be significant comparatively speaking, but it may attract some large investors. Anavex may be fishing for some larger fish is the way I see it. It's potentially positive, but it's like any other fishing trip. Will the fish be biting? What type of fish - partners, institutional investors, independent accredited investors, venture capital companies, etc.?
Money flow is beginning to barely perk up again, which should also be obvious because the share price has been up for the last three trading days. In the last 3 days, the market has been absorbing shares sold. It's likely, however, that there will be selling occurring in the next few trading days unless there is some positive news in that time frame. It looks to me the share price needs to break and hold above the 6.35 - 6.50 level, roughly speaking, to continue the short term move. Longer term, the share price has been gradually trending upward since late February - early March. I am a long term holder having traded a few shares on the ups and downs. On the fundamental side, I am hopeful as I have constantly reviewed the science. I have never lost any money on this stock so far, but I really do not care so much about that. Most importantly, I will be extremely happy if the Anavex drugs work and benefit humanity. I am too old to spend the money I have now. I like making money. I always have, but that is not so important to me now.
The NASH CX study is blinded but the number of patients and power of the study is definitely open to analysis. On the recent call we learned that the FDA was one of the key drivers in GALT’s trial design that assumed a 25% dropout rate. This isn’t surprising given the recent reductions of recruitment in other trials where the need for a liver biopsy was having an effect on patient recruitment. This is probably why the FDA suggested a robust trial design to account for significant dropouts. Liver biopsies by themselves are delicate procedures that entail significant risks to patients. Anecdotally it’s not hard to draw the conclusion that the reason for such a disparity in the unusually low drop-out rate is due to the clinical activity of the drug. Traber reflected, that to date “a total of 10 dropouts out of 162, which is a 6% rate.” Keep in mind the trial was designed for 156 and in a way was oversubscribed. Having 152 patients left in the trial at this late stage is quite encouraging since if you assume the current dropout rate continues then only 5 more patients would be expected to drop out over remaining 5 months of the trial ending in August. The reason this point is important goes to the power of the study which should be approximately 95%. It is clear that any efficacy data out of this trial should be treated a pivotal.
I, of course, am only speculating. Maybe the end points of the Galt study are being met for possible provisional approval.
It has reported that GALT is due out with its topline NASH (Nonalcoholic Steatohepatitis) CX trial results in December this year. The company has hinted at the possibility of a Breakthrough Therapy designation if they meet their regulatory endpoints on Hepatic Venous Pressure Gradient (HVPG) and Fibrosis. There seems to be a feeling that there may be a pathway toward provisional approval as they outlined their plans to break the patient groups up into subsets for a follow on phase 3 trial. My understanding is that a few points of improvement in HVPG may result in provisional approval.
The company will need the cash to ramp up and market if it obtains provisional approval. Again, this is absolutely pure speculation, but I cannot think of any other reason for this large offering.
Today's financial report. Note: "receipt of $2.1 million in research and development incentive income."
Tom is not speaking in absolute terms, but his technical analysis in using Fibonacci, Elloitt Wave, etc., is excellent in informing about what could happen -- mainly what could happen in the near future. His contributions to this board are valuable. No one can predict the future with certainty, and he is not attempting to do that as he has acknowledged. He does a superb job using his tools to interpret what the charts look like so we may be able to better understand the price action as reflected in charts, which is a history of what has in fact occurred. It's all about where we have been and where we may go. Within recent months we have been trending upward. Tom, of course, sees that, but he reminds us too of the ups and downs we have and will continue to experience so we may make decisions about whether to take short term profits, trade in and out, and/or hang in there for the longer term. We should thank him for his contributions.
I think the examples could be hypothetical or real, but that we should not interpret them as real. It's best we consider them hypothetical, which they may very well be because we simply do not know. In any event, we need to keep in mind the importance of the protection the patent gives Anavex, assuming the molecules involved are at any point proven to have efficacy for any applicable neurological conditions covered. Approval and protection of a new drug is a difficult, long, tedious, risky and expensive process. I am doing my best to be patient in keeping faith that Anavex is on the right track, and that its drugs will benefit mankind. No one can predict the future, but I think we have made progress one step at a time.