Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
This is a good and serious question. One would hope that there will be other medications that could be RXed along with A2-73 to help those that are afflicted. A synergistic effect with other medications would likely result in even greater acceptance and wider use resulting in more profits.
Happily, A2-73 is unlikely to contribute to a BP favorite franchise of making big profits on drugs to counter side effects of its other drugs. However, we can bring them along for the ride to fight this terrible disease with a combination of approaches. As Gilead proved with its HepC franchise once there is a low side effect and effective treatment more will seek it. It is a very big pie any other drugs that can help as well will make it a bigger pie. Everyone wins, and most importantly the patients.
Go AVXL!
You are joking right? When it gets approved the will likely command an almost astronomical share price on a secondary IPO. AVXL could likely raise enough money to buy a manufacturing and distribution company lock stock and barrel. The value of AVXL would be so deep as to be hard to fathom at this point. Funny joke you made. The dry humor of facetiousness.
Go AVXL!
The Article in full, Thanks goes out to "imho"
CONFERENCE COVERAGE
Sigma-1 agonist presses forward after positive results in small Alzheimer’s trial
Publish date: December 13, 2016
By: Michele G. Sullivan Frontline Medical News
Key clinical point: An agonist of the sigma-1 receptor was associated with stable cognition and function over 57 weeks in patients with mild-moderate Alzheimer’s.
Major finding: At 57 weeks, the mean MMSE score stayed around the baseline of 20. The ADCS-ADL declined slightly, from about 70 to 65.
Data source: A phase IIa study comprising 32 patients, 25 of whom completed 57 weeks of treatment.
Disclosures: Dr. Macfarlane has no financial ties with Anavex Life Sciences, which is developing the drug. He reported consultancies with Eli Lilly, Janssen-Cilag, and Lundbeck.
AT CTAD
SAN DIEGO – A novel Alzheimer’s disease drug candidate appeared to stabilize cognition and function over 57 weeks in a small, early-phase, open-label trial.
MD-IQ QUIZ: Cortical thinning & depression in elderly patients
Patients with mild to moderate Alzheimer’s who took ANAVEX 2-73, an agonist of the sigma-1 receptor, experienced virtually no decline on either the Mini-Mental State Examination (MMSE) or the Alzheimer’s Disease Cooperative Study–activities of daily living (ADCS-ADL) functional scale. These findings correlated with significant improvements in the P300 evoked potential test – an electrophysiologic measure sometimes used to approximate synaptic connectivity and cortical processing speed.
letter tiles spell the word Alzheimer
Agnieszka Letowska/Thinkstock
ANAVEX 2-73 (Anavex Life Sciences; New York) also conferred an unexpected benefit upon subjects with insomnia. “Any patient who scored on the insomnia measure [of the Hamilton Depression Rating Scale] at baseline had no sleep disturbance at all by weeks 12 and 26,” Stephen Macfarlane, MBBS, said at the Clinical Trials on Alzheimer’s Disease conference.
The findings must be interpreted cautiously. The phase IIa study was designed to assess safety and tolerability; cognitive and functional endpoints were secondary. It comprised only 32 patients at baseline, 25 of whom completed both the 5-week, randomized, dose-finding, crossover trial and the 52-week, open-label, extension study. There was no placebo comparator. Instead, the study used three different sets of historical control data taken from other Alzheimer’s studies.
Nevertheless, the positive results are enough to propel ANAVEX 2-73 forward. The company will continue to treat and follow the extension study cohort, and plans to launch a placebo-controlled study in 2017, said Dr. Macfarlane, head of clinical governance for The Dementia Centre in Melbourne.
The 5-week, randomized, dose-finding, crossover trial started one group of patients on 30 or 50 mg/day oral ANAVEX 2-73 for 11 days after an initial 2-day, single-dose, pharmacokinetic analysis, followed by an 11-day washout period, and then 11 days of 3 mg/day or 5 mg/day intravenously. A second group first received 11 days of 3 mg/day or 5 mg/day ANAVEX 2-73 intravenously after an initial 2-day, single-dose, pharmacokinetic analysis, followed by an 11-day washout period, and then 30 or 50 mg/day oral ANAVEX 2-73 for 11 days. This was followed by a 52-week, open-label, extension trial of 10-50 mg/day orally, titrating each patient to the maximum tolerated dose. The extension phase was originally planned to last 6 months, but patients and caregivers wanted to continue on the medication, so the company extended it to 12 months. It is ongoing.
The sigma-1 receptor targeted by ANAVEX 2-73 is found on neurons and glia in many areas of the central nervous system. It modulates a number of processes implicated in neurodegenerative diseases, including glutamate and calcium activity, reaction to oxidative stress, and mitochondrial function. There is some evidence that sigma-1 receptor activation can induce neuronal regrowth and functional recovery after stroke.
The sigma-1 receptor also appears to play a role in helping cells clear misfolded proteins – a pathway that makes it an attractive drug target in Alzheimer’s disease, as well as other neurodegenerative diseases with aberrant proteins, such as Parkinson’s and Huntington’s diseases.
In preclinical testing, ANAVEX 2-73 showed an additional cognitive property, seeming to display a cognition-enhancing effect in both wild-type and AD model mice.
The mean age of the patients in the extension study was 71 years. The median MMSE score was 20.5. Most patients (78%) were taking a stable dose of acetylcholinesterase inhibitor. During the extension phase, they were titrated to the maximum tolerated dose; 14 mg was the minimum dose necessary to achieve a therapeutic effect and keep the MMSE stable, but Dr. Macfarlane didn’t discuss detailed dosing.
The primary endpoints were safety, tolerability, and pharmacokinetics. The exploratory measures included the P300 electroencephalogram, MMSE score, the Computerized Cogstate Alzheimer’s Battery, and the ADCS-ADL. The Hamilton Depression (HAM-D) Scale was also employed as a neuropsychiatric symptom measure.
The cohort had low baseline depression scores, with a mean score of 2 on the HAM-D. By study’s end, that had decreased to a mean of 1 point. The biggest change was seen in insomnia; all patients who endorsed it at baseline reported it gone by 12 weeks into treatment.
Patients also reported improvements in their ability to work or do other activities, in anxiety, agitation, hypochondriasis, and insight.
The P300 wave amplitude showed a small initial bump from about 6 to 7 microvolts by 4 weeks, and then a dip back down to about 6 microvolts until about week 32. Thereafter it steadily improved, landing at around 8 microvolts by 57 weeks – a level usually seen in healthy age-matched controls. There was a significant separation from the P300 decline seen in a matched historical Alzheimer’s cohort, which dropped to about 4 microvolts over a 52-week period while patients were taking donepezil.
The study employed a second historical control group in another cognitive assessment using the Computerized Cogstate Alzheimer’s Battery. All subjects in the large Australian prospective cohort study, called AIBL (Australian Imaging, Biomarkers & Lifestyle Flagship Study of Ageing), were taking standard of care Alzheimer’s drugs. Compared with that cohort, the ANAVEX 2-73 group experienced benefits in processing speed, attention, and working memory, which became statistically significant at week 31 and continued to grow.
At 57 weeks, the mean MMSE score was stable, hovering around the baseline of 20. The ADCS-ADL declined slightly, from a mean of around 70 to around 65.
Finally, the investigators used yet another historical cohort as a comparator in a statistical analysis of projected cognitive and functional benefit. Compared with a pooled, placebo-arm, cohort study conducted by the Alzheimer Disease Cooperative Study Group over 12 months, ANAVEX 2-73 would have been associated with 1.8-point bump in score on the MMSE (P less than .016) and a 4-point benefit on the ADCS-ADL (P less than .019).
“The MMSE declined 45% less and the ADCS-ADL declined 56% less than what we would have expected from the historical control data,” Dr. Macfarlane said. “This is not only statistically significant, but clearly clinically meaningful for patients.”
Nearly all patients (98%) had some sort of adverse event, but most of them were mild transitory dizziness or headache; 76% of the events were grade 1, and 2% were grade 2. There were no serious adverse events. Three subjects dropped out because of adverse events (delirium, dizziness, and a combination of confusion, disorientation, and lethargy). There were no problematic interactions between the study drug and any standard of care AD medications.
Dr. Macfarlane has no financial interest in ANAVEX 2-73. He reported consultancies with Eli Lilly, Janssen-Cilag, and Lundbeck.
Broker Assisted Block Trades should able to capture those spoof asks. You or someone will there (or an associate here) will have to stay up all night watching the trading action on level level II and then call your broker to make the trade when you see an ask numbering in the high thousands then buy the whole ask in one trade. One can break down those VWAP walls quickly that way and discourage them from that type of manipulation game. You will provide the maximum price support of the stock you hold. (And you will win a medal of Honor from the Longs of the Board!)
GO AVXL! Longs Hold!
That was an EXCELLENT POST! I Agree! I missed that one I was busy re-parsing the CC. Lets keep 100% in house and we can spead the LPC ATM out over three years have some minimal dilution of share number but keep ALL the long term profits NO DILUTION OF PROFITS that way. In the long run much much better for the shareholders. (However, I still think Biogen is just off stage left waiting in the wings with a collaboration agreement.)
The LPC ATM may have been designed as leverage in negotiations, Missling showed he was not bluffing and fired a shot across the bow.
GO AVXL!
The 10Ks show what AVXL was paid by Australia but I believe Australian researchers and hospitals were paid directly the same way NIH helps fund trials in the USA. A respected board member(Apostrophe, I think) posted last spring with references and citation to source the average cost per patient for all clinical trials which was $34000 per year. So if this trial would be close to the average then for N300 trial cost would be approx $10.2 Million. FUD spreaders and the extremely cautious often cite cost of trials on order of $100mil but that would be a LARGE trial of N3000 which is not planned and should be unnecessary. One can look on the FDA web pages where trials are explained and an N300 is perfectly acceptable and normal. N300 is the number that is planned. So best estimate is one to two years at $10mil a year. AVXL can do this itself with a little help from grants for AD and outside funding for Rett's and Parkinson's. This would likely bring the most value, LONG TERM, to the shareholders.
Go Avavex Life Sciences
The Phase 2 for A2-73 was mostly paid for by the Australian Government (FACT-See 10Ks) who will also pay much of the Phase 2/3 of the 300n in Australia by payments to AVXL and directly to the Australian Hospitals conducting the trials. This MIGHT be approx 1/2 the total cost. We should expect to get NIH funding for the US sites of the trials. If there is to be sites in other countries their Govenrments might be asked to pay their researchers and hospitals.
JMHO
Go AVXL.
You must be pulling everyones leg you mean the Jim Cramer who employs Adam Fueurnstein at the short shill rag TheStreet.com? Come on man! Be aware people! Someone else good intentionally wrote to The Stansberry Report which is another one of Cambridge Groups sensationalist "get rich quick rags" that sell investment news letters to the lazy and gullible. Another one of there Investment News Letters is "Agora" remember them and the stupid $hit they did to pump AVXL to $14 in order to sell its worthless "get rich quick" Investment letter. Come on man!
Stay focused on the company's developments & science and ones' own money management.
Stay Calm and Carry On! Roll with the punches, today was standard operating procedure in this stock sorry to say. Let management handle the PR and promotion as it sees fit. Better to concentrate on the development of the drug, IP and regulatory affairs. AVXL has experts in these fields inside the company. Some say the best way to have others listen carefully is to whisper. The results of our developments MIGHT eventually ROAR!
Go Avanvex Life Sciences!
Connect the dots. Think like a detective or a CIA Intelligence analyst.
Put all the players on the wall. Now make a timeline of events of the past.
Write down all of your clues.
Where are we on the timeline?
Why was the earnings and CC moved up twice?
First from 12/21/16 from 12/27/16 then today after-market close?
Biogen recently canceled two collaborations. Another one today,both after the MTA with AVXL.
What are the recent interday stock trading patterns? Down in the morning then climb into the close? Does that indicate accumulation to you?
Is there other evidence of accumulation?
Conclusion? Bias towards significant FA news at the conference call after market close today or not? Watch if the power hour will blow-up the share price.
I have made my conclusion to this and acted on it already this morning.
The question I am working on now is whether or not there will be a trading halt in the aftermarket or not. I am open to comments on precedents and likelihood of that.
Update since I have been writing, price temporarily stalled at 4 weeks and 13 weeks high at $4.88, just as you would have targeted. You are right Tom, this is so easy a caveman could do it. My question now is what will happen if $4.88 is broken through this afternoon? (as if a would really sell any before the CC! Ha Ha)
Congratulations Longs this will be your Day!
Go Anavex Life Sciences!
8 mil for the A273 test quantity of drug from Biogen is a possible explaination.
Brilliant move freezes the shorts to force cover by with daylight precision bomb dropping after the close.
Earnings release comes before Christmas this year. 12/21/16 before market open. Check with your brokers like I did don't just guess based on previous years.
Think or Swim platform now states earnings call is before market open on 12/21/16. Last week they had it listed as 12/27/16 before market open. Ummm they moved it up apparently. Signal that they can move it when they want should keep the nefarious players off-balance.
GO AVXL
Looks like Insty buys are increased quite dramatically from yesterday. Thanks from an obstinate long! Haha
Go AVXL
Good info thank you.
Quite possible from what I understand these types of VWAP walls are set up with "ALL or Nothing ASKS" so they can not be bought off in pieces so they sit there psychologically driving down the price. Then they can only be bought by Broker Assisted Block Trades. The MM may have gotten the shares they wanted just below the $4.33 then canceled the order causing the price to spike then they sold around $4.47 to capture quick profit. But I do not care what I care in that the price spiked after they pulled it which shows genuine buying pressure.
Go AVXL!
Beg to differ. Volume is greater than this time yesterday and up volume of the second hour is approx 2.5X as great. I see this volume increasing as the day wears on and the price busted through a 98K (spoof?) ask at $4.33. I may be wrong but I watch carefully and not just guessing I am seeing evidence of this volume building. I do not have any evidence of where it is coming from but suppose short covering is a reasonable supposition although more likely is is increasing somewhat across the board.Sitting firmly above the 200ma at $4.28. This rally looks to have legs on increasing volume. Good follow through of yesterdays break-out hammer candle. It is setting up nicely technically for a continued break-out into some important FA developments.
Go AVXL!
98K spoof bid just got taken out! Up we go!
Go AVXL!
Agreed if one is to trade at all one should have an advace plan. Knowing the Algos will the better fills most of the time but need to make some plans and trade around the MM games the avoid getting totally fleeced as has happened so ofter with this stock and many other smaller cap stocks.
Sounds like the Donz triggered a Tourett's like syndrome. I wonder if that appears in the literature or label?
You are usually fairly right on with your targets. I suppose I should have a plan in advance. I just hate to sell on the way down it it feels like adding and abetting the MM's HFT algos to take unfair advantage of retail and other traders. I would rather trim a little on the way up to keep dry powder an artificial spike down that you and some other helped stem with your accurate stink bids yesterday. I had loaded the boat the day before thinking the pennant had reach it's pinnacle and was ready to breakout. I thought it would sometime this week with the conference at hand I was just a little early. I read some commentator on Zack's that believes 80% of the trading volume in even big caps and EFTs are MM HFT Algos making money on the little manipulated moves. I hate to venture how much of the volume is artificial MM HFTs in little Bios like AVXL. I just hope we get some real volume which will show the true direction of the price action.
Good Luck to All Longs you all deserve a break your way.
GO AVXL!
Chart of 6/27 to 7/27 shows a break-out from the same level we are at now. Price run for 11 straight trading days with just a one day pause on 7/1. then run for 5 days to 7/11 to a high of $8.30. Then traded sideways for for another 10 trading days in the $7s until the 7/27 data release and subsequent dump and slam down. The difference this time is the run is starting concurrently with GOOD Data not in anticipation of data. Also this time the data is much more significant and there are more catalysts on the horizon and developments such as the Biogen tie-up. After considering our discussions here I remember how I outsmarted my self and sold a chunk at the start of the run to have to chase it for 5 days straight but just lucked out because I jumped on some other fast movers and caught AVXL when she paused on July 1. (If I had only known AVXL would have fallen back to earth in 6 weeks,,,haha would have saved me a lot of trading work)
I am thinking I do not want to mistake again and will try not to sell any before it reaches at least $6.80 then maybe just trim some options and hold all the stock long term. I am hoping fundamental developments will break the cycle of boom/bust.
I am sure I will miss some trading opportunities but the risk of getting left behind a huge rally is greater for me.
Good Luck to All Longs!
Go Anavex Life Sciences!
An Impressive candle today. Looks like a possible break-out. Confirms the pennant formation with the base line and pinnacle at $3.70 and the top of the triangle at $4.28, which fits what you are saying. The strength of this candle might lead one to believe this break-out has technical legs. Hammer candle with a long tail down, significant in that it effectively filled the up gap at the open and the "bears or sellers" could not push it lower or hold it there as it rose steadily though-out the day and finished at high of the day significantly higher than the open on good (not spectacular) volume. This signals a possible momentum and sentiment change to the up-side. Some "CANSLIM" and momentum traders who wait for these types of momentum break-outs might come along for the ride tomorrow and push it higher without further news. Where the price is right now at $4.20s above fairly strong support of $4.14 which was some struggle to break through today when it was the resistance of the highs of the "real bodies" of the last 4 higher candles going all the way back to September. If is can break though $4.28-4.30 as Resistance/targets there is not much resistance from a "candle TA" perspective below $6.80 but as you say there are "target zones" below that are mapped by your TA methods that are not a part of traditional candle stick TA, but I take your word on that. RSI is now 68% and rising sharply today. These pennant formations are some of the strongest and most reliable from a candle stick TA point of view. But we all know what the MM can do with the HFT Algos to shape charts. It looks like bias is still to the upside and we could get one of your $1 moves or a series of .40- .50 moves which would be preferable for longs. We will see but that was a strong candle today the might signal a strong technical break-out coinciding with fundamental developments.
Thanks for your charting and good luck to all LONGS!
Go AVXL!
I like the way your Fisher Transform is shaping on the 60mim chart. Thank you for turning me on to that. Looks like we turned a corner and now in an Uptrend. I do not understand how it works but it does seem to be a leading indicator. I was adding on the way down from mid $3.70sin the morning then quit watching and the FTR played out as you informed us it should and we had 5 hours of positive Share Price. FTR really seems to be an indicator of price direction. That combined with a today's confirmation of the STAR DOJI of Dec 2 lead me to believe was a good chance of a positive bias going forward.
Always good to read your posts as one can usually trust what you say is the truth as you see it.
Good to have honest stalwarts on the board.
Go AVXL!
Well said! This is what I am seeing in the current chart. A pennant formation with the high on the triangle at $4.28 and a base of the triangle at $3.70 and the pinnacle today in the mid $3.70s Coupled with a star doji on Dec 2 that was confirmed as a buy signal today. Many times these pennants break hard one way or another. But with the star doji confirmation signaling a possible change of trend and the afternoon action trending up leads me to have a bias to an upside break-out soon. So I loaded the boat in the $3.70s today. But, as you say, the big money may try to goose the action one way or another.
I appreciate all your TA contributions as you map out targets and my TA is more rudimentary looking instead just for bias as to the direction of the price based on candles and patterns. I might add that in the past many of your targets were spookily prescient.
Good Job Keep it up!
GO AVXL
Plaque drugs fast tracked to failure so the Industry will move on to viable drugs and solutions. Poor drawn out trial designs.
Will A2-73 work? Who knows but at least it is something new and a different approach. "We think differently and have NO FEAR"
The brilliant as you give me confidence. Added 10% at the open. We shall see "In it to win it!"
Missling is an American! You got that? He is in it to win it! You got that? Missling matriculated from Northwestern University in Chicago a top MBA University. Missiling is an American!
"We will start the war from here" Lt. General Ted Roosevelt, Jr. on Okinawa after landing off target.
Missling has landed 37,000 barrels of gasoline. Why?
He gave good and sufficient notice.
http://www.ridingthebeast.com/numbers/nu777.php
The "Typhoon of Steel" is just Offshore!
I read that. Perplexing as it is Green Light might mean short attack. The way to play this rough GEM is long term horizon averaging in as we go. Generational wealth aka Gilead, Celgene and of course Boeing! Titan/Minuteman III Joking of course, or am I?
As you so eloquently spoke in a prior response there it a big difference between greed and generational wealth. Some may be in for 2 to 3 years others of us may be in for 5 to 15 years as a suspect our BOD is. Case in point GILD and CELG.
Do the math from 15 years back.
We differ in that I am in 150% AVXL with many options as well. Win or lose the sun will set and rise regardless and I will be there to see it in many places of the world whether a backpacker or philanthropist. Of our music and of our people and the festivals of the world. These are "Our People Our Planet"
We will reach our destination! I do not care if anyone gets to read it as I enjoy to write it. I am glad you are one of those that got to read it. CBD we will reach our destination. (play REM "Driver 8")
Nice work detective. Riddle solved.
Nice work Detective. Riddle solved.
Exactly, it is as if the reason for the 41 week PR is the Message: "And the Train Conductor(Missling)says Driver 8 Driver 8(stockholders & Scientists) you will reach your destination"
GLTA Longs and Believers
They go about their killing..quietly. Who wrote that and of which novel? I say Anavex Life Sciences and her scientific collaborators will write a very important chapter and maybe a whole book on treating CNS maladies. Make room for the Screaming Eagles!
BIIB might be a BLUE CHIP investors wet dream. Lilly would be a buy for me on a pull back. It is crazy that most buy BLUES when they are up when the whole Idea of being a Blue Chip is long term. AVXL is a white chip and most will sell when it is a red chip. I am holding for blue chip/black or orange chip hehe.
Thanks for paying attention, Bro. Yes I did sell some in a run up in June and had to jump on Galena Regulus and Threshold to give chase I lucked out as AVXL stalled and those three spiked. But trust me it was pure luck borne of desperation to chase our little red head. Little did I know I could have just waited,,,,and bought cheap! haha
I admit I am the world's worst trader. GILD and CELG has been good but I was not diversified. Diversification is stupid and for the meek and uninformed but mostly for those that seek to maintain wealth not grow it.
I am 100% Long AVXL to a shocking degree. I trust it will bear fruit eventually as will your major play in the other company. Cheers to both and thanks for keeping it real Bro.
Wow! Great post! Where have you been? Quietly accumulating? I was until today I had to announce I was paying UP for more shares as I see as you see. It is as if the fairy tale of the Emperor has no clothing has been turned on it's head. I see the Emperor in fabulous Regalia presiding over an expanding Empire. But I am a long firm LONG so what do I know? Ha ha
Opps! Just as I thought smart money is on the BUY! Nice to be in the majority for a change! Thanks P'Xena!