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Thanks for sharing your options experience and knowledge jimmy667, xodcode and investor.
"Paper trades" Please post charts so I can learn how to chart and paper trade avxl. Thanks in advance Grim.
Top, absolutely, thats THE FLAMING BUY signal!!
The rough mmse reports are good, but until the ERP methods are better defined and quantified, that VIDEO (and everyone believes video) RWE, is confirmation of the efficacy and mmse signals.
Xena, re Pura, thanks. I was wondering about why pura was listed as Avxl news. Not enough ads I guess.
Cape cod, look at the anavex.com website. Find the presentations. They give good data and charts for results and biomarkers. A2-73 is not as oriented towards plaque reduction, but as the best (in many cases only successful)drug for AD and many other CNS diseases, pushing the frontiers of cns knowledge, new biomarkers have been discovered and old ones are being better quantified.
"Year of Execution", "2020 YEAR OF RESULTS"!!
LakeshoreLeo, all green now for me. Never sold only averaged down. I always thought you were right that the "Kaminsky Event" would happen, and that would be the final verification. Well I think the final event was the AUS news9 story, letting the cat out of the bag.
The Kaminsky event will be this year...a little later than we expected. Lol SOON for that!
Xena has collected all this info for years...xena you should write a book, SOON!
App is CNBC.
Shows extended hours too.
NICE! App says 5 day return 43.6%
To all the patient longs...relax and enjoy the ride!
Cog, I totally agree, I think the news report is what started the SP movement. That by definition, gets the word out. Bishop moved on it as well. EFFICACY VERIFICATION that I had been waiting for!
Thoughts....I always thought that when A2-73 made the evening news, it would be huge. This happened a week ago in Australia. Interesting to compare the information from that news, with the info that CM includes in his PR today. CM definitely is seen to soft peddle news. I think this leaves investors to read more into his low key PRs. Just the way it is.
I think the PR today says we are seeing lots of positive OLE data, and we got this.
All the accumulating data will lead to a better case for provisional approval for a general CNS drug.
It appears that CM is delaying letting the cat out of the bag for as long as possible. I wonder is it coincidence that Rett and PD trials get delayed and now the results are actually going to appear at about the same time. Why would this be? To not attract attention to Anavex? Just a very conservative CEO? Wants the SP to explode to maximize any buyout price? The longer data can be collected, the better the case for a general CNS approval? If you can hit a home run at will, why not go for a Grand Slam?
Not sure at all. All of the above?
Lots happening with Anavex this year. The rest of the quarterly CCs should be good!
Prof.MacFarlane, leading Ausralian dementia researcher, will certainly have a voice in provisional approval for Australia. He is at the "tip of the spear" for Anavex.
Nice find TTT. Thanks.
Gernee, F1ash regarding PD trial dosing. Remember this is a big (expensive and big for anavex), 120 patient trial. Selection of the dosing was primarily based on estimated tolerability and efficacy. They wanted to pick two doses that would allow a plotting of efficacy vs dose line. They did NOT want to have to adjust doses because some patients could not handle the dosing!
The High dose selection is the most critical. The number one criteria for High dose is: It must have a history of 100% tolerance. If there was intolerance to the high dose then, adjustments would have to be made and this would mess up the trial arms and make interpretation of data much more difficult. The second criteria for High dose is it must be in the region of efficacy.
The Low dose was not as critical, and just needed to be in the region of efficacy, but significantly lower than the high dose.
With these two points a plot of efficacy vs dose is possible. And as I supposed, in a previous post, IF the results seemed efficacious\POSITIVE, THEN the OLE trial could be run and supply the MTD (max tolerated dose) for a nice three point line/curve. Waiting for positive results might explain why the OLE trial was only recently confirmed and started. By my reasoning, the OLE trial starting is GOOD NEWS!
Nidan, you raise some good questions.
First a few questions for you, regarding your questions and scenario. Are you assuming Anavex be the talk of the investment world with positive top line results for PD? Anavex makes the evening news?
If either of these scenarios then addressing your questions:
Nidan a. Will BP be in denial and attack?
I dont think they will be able to deny the news and science internally or to their shareholders. They are probably watching Anavex right now, and hoping for failure.
Nidan b. Will BP throw money at AVXL or try to partner? (who cares)?
I think this is the most likely, and the one I care the most about LOL! They will attempt a buy out. They have money, AVXL may still be
cheap/undervalued! BPs could be accumulating AVXL as we speak! Many argue that we have poison pills in place. But many would be willing to sell out at $6, doubling or tripling the investment they have been sitting on for years. Dr.Missling has made known his well reasoned thoughts on 'partners'.
Nidan c. Will W/S do an attack on FDA/AVXL/other? Doubtful, imho.
Nidan d. Will the CNS patient public understand that just one treatment has been used to treat multiple CNS diseases and the best is yet to come?
I think word will spread fast. I think the respective communities (Pdd, Rett,?) will get the word out quickly.
Nidan e. Will FDA and other WW regulatory bodies chip in to make this happen or not?
I hope they follow good science and regulatory principles. I dont want to see them bend to political will, because that always leads to unwanted results down the road (possible Biogen + Acu..w/o proof)
Jwc3, you had already found a Dr.Missling quote, where you concluded the pdd trial data was positive. My analysis supported that conclusion, but from a different angle. I originally wanted to reason out what was being done with the 'early' completion patients, but instead found more interesting info.
Follow up to investor2014s good PDD summary.
A major question seems to be, what happens to the 'early' trial patients that completed the trial while others were still enrolling. These 'early' patients could have completed the trial as early a Jan.2019!
As usual we are looking to make sense of information, where there are many unknowns!
The blinded trial, when unblinded will provide data for High dose, Medium dose, and placebo. So what is really left to study?
I will look at some key phrases in the OLE descriptions:
RATIONALE:
We want to get more information about how ANAVEX2-73 might improve cognition in Parkinson’s disease with dementia.
You will receive ANAVEX2-73 if they participate in this study. The therapeutic dose will be a target of 50mg; however, the final dose will be determined based on the your tolerance. (Also, titration noted by F1ash!)
MAIN OBJECTIVE
Continue assessing the safety and tolerability
PRIMARY ENDPOINTS
Safety related
SECONDARY ENDPOINTS
Efficacy related
It looks like the OLE will add one more data point, maximum tolerated dose, and the associated efficacy for MTD. It appears that they will titrate up to determine MTD.
After OLE, there will be three points MTD, High dose, and Medium dose.
CONCLUSIONS
It appears that they have confidence in the High and Medium dose data, as they are not being pursued in the OLE!
It appears that the High and Medium doses are efficacious, as the trial is continuing to OLE!
The initial trial should have results by mid 2020, with the OLE following a reasonable course. Still cannot resolve the 'early' completing patients question, but maybe it does not matter.
Wow, strong signals from AZ, Rett, and apparently PDD.
Thanks to Investor2014, F1ash, Doc328 for contributions.
Biostockclub, yeah interesting that biib seems to be betting on both teams(theories) LOL. Should be upsetting to biib investors that have heard their plaque pitch for years!
Regarding biib confidence in aducanumab, I say, and hope the FDA says, run another trial and prove it.
Cherry picking, a term used frequently around here, might be called on biib. But after thinking about it, maybe it is a term that is not valid to use, for drugs in early trials. The reason being that early on, companies are not sure of what doses to use, what results will be, or strength of response. Biib might have found some dosage for some subset of their patients where there may be actually an improvement. Not cherry picking, just data analysis. Ok, now it is time for them to prove it. Let's see how strong the signal ultimately is, and how large the improvement population actually is. I would say they have a lot of work to do on that, at best.
Anavex on the other hand has strong signals. Can we say it was cherry picking? No just data analysis! Anavex is trying to determine dosages, establish concentrations, and determine populations affected and why. They were small population trials, given, but now anavex is using larger pops and refining parameters.
We seem to have a stronger signal than they had, and it looks like we are farther along the road to approval and understanding our a2-73 drug than biib is with aducanumab.
It seems like biib is trying to get around the system by pressuring/challenging fda to approve aaducanumab, and not prove the signal that they claim to see...by running a trial. Lol fda is being tested/trialed now! They are supposed to be the impartial judge/referee...we will see if they pass the trial! And not succumb to BP.
Thanks for the report bio!
Just passing along my thoughts on biib.
Anders, I have a relative with Autism too, so I have some skin in that game also. I will say, there is no proof that A2-73 will have ANY affect on autism, and I do not want to argue that point. However, as you know A2-73 appears to be a general cns drug, so it MAY help with autism. As you have seen in the last few years we are still learning how A2-73 works, from homeostasis, to gut biomes, to gaba glutamate ratios. No one can say NOW, how exactly 2-73 could affect autism. A2-73 might relate to autism (genetic) the way it relates to RettS( genetic). It may not be a cure but it may improve some symptoms and quality of life. That is my hope.
There will need to be trials run to know exactly the affect of 2-73 on autism. That said, with PD provisional approval, as I understand it in the U.S., a doctor could prescribe A2-73 for autism, before/parallel to autism trial. That is also my hope. Not sure about the laws in your country, lol talk to a lawyer...yourself.
As Jimmy pointed out, patents are written as broadly as possible, and frequently before there is actual proof that the invention works. That is what anavex does, and then writes more patents as more is learned.
Plenty of reason to be hopeful, and I think you are on the right track trying to get your hands on some A2-73.
Good luck my friend!
Biochecker. So Bishop was bought off, jeopardizing the integrity of his investment newsletter, and then Missling got to Forbes too.
Nah, you should have gone with my interpretation of your post.
Bishops and Forbes readers read about Anavex and understood...and bought. Much more likely.
Checker4. Agreed! You say once people read about AVXL, they want to buy it!
Abew, the 2.89 50000 bid just went away as the price moved up.
I wonder if it will come back higher.
I am using the La, Stock Level 2, app. I am curious what do you use?
The important news from Dr.Missling is the clock starts in two weeks!
This is the news/PR we have been waiting for.
The 17 week PDD trial starts...the light at the end of the tunnel will get brighter every day. This is the big one!
Cheer up longs!
Bas, yes he said adding two new territories.
Dr.M:
Enrollment pace..expect actually a increase in enrollment because we are adding sites.
We have to appreciate that so far the enrollment has been exclusively in Australia and I understand that we have reached the highest enrollment in Aus ever, in the history of a alz study enrollment in terms of numbers recruited for alz patients, expanding into two additional territories, this will allow what we believe an addition to the existing sites in Aus, for an uptick in enrollment speed for the Alz study.
We have not set a target for completing enrollment.
Treden et al. Regarding the consortium...Yes, we have done some of these, like sometimes ERP, now adding gut tests, etc. The purpose is exactly as was quoted... To come up with standardized, validated psycometric testing procedures, that are accepted industry wide.
When the procedures are written up, every CRO can simply specify testing per the published procedure. It helps the industry not having to invent the wheel for various, future STANDARDIZED PROCEDURES.
I have been in these consortiums. No company provides any more info than is needed to reach the goal (standards). Companies are very careful about what they reveal. Frequently members of a consortium are competitors!
Dont think that this is a grand partnership. It is NOT. Now it does give companies a chance to rub elbows and dinners with other industry leaders, and something could come from that, but dont expect anything like that.
Fitzy, at times scientists/technical people will come under pressure from upper management to push a sham or poor science. The scientists/technical people respect science to much, so they will not take part, or resist taking part, in shenanigans. NOTE-Six weeks ago Biogens head of R&D left Biogen. We can fill in the blanks...
Results before the updated dates! Here's why...
Upper management of companies is keenly aware of the credibility, financial, and legal issues when missing commitments and dates.
Rest assured the new dates are conservative dates, so they should be readily achieved. Worst case, the results are near the updated dates. Dont expect the dates to be pushed out again!
Voucher worth twice Anavex market cap!! LOL
Per Flash “AbbVie buys special review voucher for $350 million”
Brich, nice. The SP doubled the day after PR. Then SP doubled again three months later. And three months later the SP had doubled again.
Lima, I think she is clearly from U.S.
I wondered where she was from also.
See my previous post #214135
The car is a typical U.S. SUV or minivan.
And near the end of the video, some clearly says in standard U.S. English (Not U.K. or Aus.):
Penny, Havana very well could be one of rhe A2-73 six patient >18yrs
cohort!
It states she is 22!
Near the end of the recording someone (mother?) says:
That was said in standard U.S. English!
Havana leading the way.
TAKE THAT RETT SYNDROME
as the post states.
Great post Penny!
IF early positive results for Rett and Parkinsons, say January-March next year, will make for the hottest winter on record for Anavex longs. Anavex will have a proven GENERAL CNS disease SOLUTION!
Anavex will have so many requests for licensing and offers to help with trials for licensing rights, that Missling will need help putting the deals together. Funding for 3-71, MS, Autism, FragilX trials etc etc etc will be NO PROBLEM. Oh yeah and AZ results forthcoming! Who knows why MS was removed from pipeline now.
Anders will apply for head legal council position.
All questions and FUD to be resolved in a few months.
"...patients...are consistently expressing the wish to gain ongoing accesss to this investigational therapy." From Dr.MacFarlane.
Years later, aint placebo affect here! Wouldn't be bothering if it werent working.
Agree plex, these are the key words to the whole PR.
Anders, Yes price too! IIRC there is a gene therapy being studied for Rett also, and it works well, but the price is very very high. Maybe someone else is familiar with it.
Anders, Oh yes! Our number 16 score improvement is still valid, just as the 6.7 value is for Trofinetide. Dr.Kaufmann called it strong! I am adding that ours is 2x to 3x stronger than Trofinetide, depending on whether the placebo effect is included.
Yes Anders, you got it. Also, I was probably to conservative. If we subtract the placebo effect from BOTH Trofinetide and A2-73 data, we get the truer readings because we eliminate the placebo effect:
(RSBQ - Placebo = Corrected RSBQ avg reading)
Trofinetide------> 6.7-2.3 = 4.4
A2-73 -----------> 16-2.3 = 13.7
***A2-73 is actually >3x more effective! ***
As an investor this is important to know. Because if the competition has better numbers, then our drug will rarely be prescribed!
Note: the A2-73 data is from a small, non-placebo arm Rett trial.
Doc, yes your figure 3 is of the raw data, my table 3 is of the averaged values from your raw data figure. Totally agree that placebo effect is real and significant, and is part of every detailed study. Also waiting for our placebo armed study!
Doc and Anders see my post Comparing Rett Trofinetide results to Anavex results.
My post shows highlighted tables Doc references.
Note the Trofinetide trial was with 82 participants, and placebo controlled. The first 14 days (D14) obtained baseline data, and the full study was for 54 days (D54). The Anavex study was 6 patients, no placebo.
The 200mg/kg dose arm shows Trofinetide RSBQ score dropping 6.7, while the placebo arm drops 2.3.
Comparing these to the Anavex scores that dropped 16 points, we can see:
1) A2-73 provided a much stronger signal, >2x that of Trofinetide!
2) The placebo affect accounts for a drop of only 2.3 points. Assuming similar placebo affect with A2-73, there is still a very strong signal, two times as strong as Trofinetide!
George, posts presentations. Interesting that Dr.Kaufmanns presentation on Rett behavior, draws links to Autism, which could be huge for A2-73. Would like to see that trial next! Also, it appears there is nothing A2-73 specific in his presentation...like he stuck to the Behavior title, and did not include the latest anavex trial (6 cohort) results! There was some tongue in cheek question about that early on.
Also regarding presentation by Neul related to Rett trials. He covers Trofinetide, but I cant tell what his charts say about it (they appear to be heavily compressed images). But comparisons of a2-73 vs trifinetide have already been done on this board. A2-73 was twice as good (using the data we have).
Disappointed that Neul did not give clearer efficacy description for the 6 cohort Rett A2-73 trial results. He did have one powerful sentence, but I am afraid it may have been lost in the forest. The sentence said there was an efficacy signal for both clinical and and caregiver measures, with correlation to biomarkers. Again already extensively analyzed and dicussed on this board(kudos to this board again). I would have been interested in his professional opinion of A2-73s signal etc.
Was Neuls data of the Anavex Rett trial results, what we thought Kaufmann would present or am i missing something?
Many thanks George!
George, posts presentations. Interesting that Dr.Kaufmanns presentation on Rett behavior, draws links to Autism, which could be huge for A2-73. Would like to see that trial next! Also, it appears there is nothing A2-73 specific in his presentation...like he stuck to the Behavior title, and did not include the latest anavex trial (6 cohort) results! There was some tongue in cheek question about that early on.
Also regarding presentation by Neul related to Rett trials. He covers Trofinetide, but I cant tell what his charts say about it (they appear to be heavily compressed images). But comparisons of a2-73 vs trifinetide have already been done on this board. A2-73 was twice as good (using the data we have).
Disappointed that Neul did not give clearer efficacy description for the 6 cohort Rett A2-73 trial results. He did have one powerful sentence, but I am afraid it may have been lost in the forest. The sentence said there was an efficacy signal for both clinical and and caregiver measures, with correlation to biomarkers. Again already extensively analyzed and dicussed on this board(kudos to this board again). I would have been interested in his professional opinion of A2-73s signal etc.
Was Neuls data of the Anavex Rett trial results, what we thought Kaufmann would present or am i missing something?
Many thanks George!
JJ, you will like this. My son is a programmer, a young one, soa I explain it to him that anavex is like Microsoft, when Microsoft was a few guys working on something called DOS...out of a house! They had not sold a copy yet but companies were interested in it, and they were working the bugs out.
They had not sold the first copy yet....and the stock was $3.
As some would say, No Sales, No Revenue, Negative PE ratio! Oh My!