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Investor, totally agree. A2-73 was never claimed to 100% cure everyone with AD or Rett, or cure those diseases! It has been shown to help SOME AD biomarkered subgroups A LOT!!
Guys remember, no one has ever seen the super responders that stabilized or showed improvements, as shown on the graph. (Graph is from a year or two ago, well publicized in Anavex docs.) Iirc someone analyzed the good responders and showed that they carried a biomarked protein that was exclusive to the good responders. They found that anavex was unlucky in that statistically, there should have been more patients with the protein that appears in good responders! I think the it was the Wild variant, but dont quote me on that.
Also, this is not cherry picking, it is data mining! Standard stuff in science. It is not a 100% cure, so data has to be analyzed! This is precision medicine!
Investor, I just looked at Neurotropes website to see when they released bad news. It appears they got the data about July15 and released the bad news on September 5. So one reference point for delivering bad news, is at about 7 weeks. That is where we would be now, if the results were bad. (I never invested in ntrp!)
Assuming, like our AD data, a2-73 helps a subset of the PD patients as responders and super responders, as you noted. Arianna/kem type analysis probably will be run to data mine (not cherry pick) and prove the upstream thesis.
Also, given TGD's proclivity for data analysis, we can expect results soon!
Atilla, and the US Rett trial, which ends in October. Good results there will propel all the Anavex Rett trials!
In four months the US Rett study will be complete. The caregivers don't have much time to whisper much before results!! AND the expected positive results of the US Rett trial, will almost certainly spur enrollment in the other Anavex Rett trials. Expect full enrollment for those trials SOONER (sooner than the usual soon).
Snowball effect.
Excellent presentation about cell biology and cell membrane receptors, and a background to understanding SR1.
Highly recommend watching.
Thanks for posting Xena!
Jager, thanks for the IR update.
Good to get a response on the Australian gov situation.
Guys, of the three A2-73 trials AD, Rett, and PD...PD is the one we have the least data for. All we have is good muscarinic data for Pd. For AD and Rett, we have encouraging human safety data (I dont want to argue the semantics...see the Drs. MacFarlanes and Kaufmanns wording). For AD we also have good anecdotal evidence, see videos.
I totally agree the SP will be hurt if there is poor PD results. But the company will not be bankrupt (dead?), as the Rett trial results will be a few months later, and the AD results will be SOON afterwards.
Welcome back anders!
Someone in my investment group made the great point that during the lockdown, there were many people that wanted to join the trial but waited until the lockdown was over. Anavex took them all in. This may occur in many of our other trials as well!!
Steady and froll, this is from clinicaltrials.gov:
frrol, yeah STARS and Newron are cool names!
I confirmed US Rett trial was over enrolled from 21 by 50%. (Anavex IR)
So there are likely >30 patients.
This raises questions as to why this occurred for Anavex, and can we expect similar, or faster enrollment in our other two Rett trials.
1) Referencing Joanne Fagg's article "Newron’s failure in Rett syndrome leaves the late-stage pipeline to GW Pharma, Acadia and Anavex".
(https://www.evaluate.com/vantage/articles/news/trial-results/rett-failure-sets-thin-pipeline)
The idea is that there are fewer Rett trials going on now, so interested Rett patients have fewer possible trials to sign up for.
2) Another factor may be Anavex's good planning to cope with the Wuhan Virus, allowing at home visits, remote evaluations, etc. Prospective caregivers\patients would likely be interested in a caregivers\patients friendly plan.
3) Maybe with more people at home (Wuhan Virus), Rett caregivers had more time for evaluations.
Not only is the higher patient count better for signal refinement and statistics, but one could make a reasonable argument that our other Rett trials may see faster enrollment.
Sokol, good posts. Motor symptoms are part of Parkinsons - rigidity, tremors and slow movement. They are tested in our PD trial as the secondary endpoint.
Mauismart...is this your investment group today?
I remember you posted this yesterday. My investment group has been holding.
Hilarious post falconer During the lockdown, parents had more time to notice any improvements in their child's health. Oh no, they would never discuss that with their friends that have similar children!
No no, not when the integrity of a trial is at stake!
(I like the gravity at the edge of the world anecdote too.)
Which Rett Trial?? Rett Trial Cross Reference
I can never remember the different Anavex Rett trials and details. Thought I would share this.
Anavex refers to the Rett trials as "Anavex 2-73-RS-00x" or "Excellence" or "US" or "AVATAR", and clinicaltrials.gov refers to them by NCT numbers.
Here is a little cross reference of them, giving some minimum details most are concerned about. (Note:ESCD is Estimated Study Completion Date.)
References--Anavex 2-73-RS-001 US NCT03758924
Details--------Phase2, N=21, 18-45yrs, U.S., ESCD=2020/Oct30 ...Note:Fast Track,Rare Pediatric, Orphan Drug(US/EU))
References--Anavex 2-73-RS-002 AVATAR NCT03941444
Details--------Phase2, N=30, 18-45yrs, AUZ, ESCD=2020/Dec31
References--Anavex 2-73-RS-003 Excellence NCT04304482
Details--------Phase2/3, N=69, 5-18yrs, AUZ, ESCD=2021/Jul31
Xena you might consider adding this to the compiled DD, maybe in a better format. Ihub does not support spaces, tabs or columns well.
Nidan, yeah article has much discussion about earnings....whhhaatt?
Program generated(bot) article. Other giveaways for bot generated articles are, lots and lots of numbers presented (pe, yoy#s,etc.), sometimes silly, like 0.0001% increasing sales.
Another bot article indicator is no discussion quotes from a top company official. Indicating no phone call from the 'reporter' to someone at the company...so all the article presents is massaged words with numbers from a database.
Checker, a nice little tidbit of DD. Thanks
I will take Dr. Kaufmann's word for the results...
He was the Director of the Center for Translational Research at the Greenwood Genetic Center, where he also held the Ravenel Boykin Curry Chair in Genetic Therapeutics. He holds adjunct appointments at Emory University School of Medicine, where he is an Adjunct Professor of Human Genetics, and at the MIND Institute/University of California Davis School of Medicine, where he is a Visiting Scholar in the Department of Neurology. Dr. Kaufmann is also a Simons Investigator at the Massachusetts Institute of Technology’s Simons Center for the Social Brain. Before these academic appointments, Dr. Kaufmann was a Professor of Neurology at Harvard Medical School and a Professor of Pathology, Neurology, Pediatrics, Psychiatry, and Radiology at the Johns Hopkins University School of Medicine.
Jimmy, here are my views on several of the issues you raised.
Regarding your question of what if only a subgroup shows improvement, or there is no improvement. If there is enough of an improvement to lead to a product, then that is SUCCESS, end of discussion. If there is no improvement, then consider
1) Maybe the SP drops to $3. Well we were at $2.5 only two months ago!
2) Rett results will be SOON. Hold on.
Remember the Rett trial results that will be finished soon. This is another potential product, no partner needed.
Dr.M has always kept enough money for 18 months on hand. Seems pretty conservative to me, with two trials data by end of year.
Also, the company can continue to raise money through dilution. That is what has been happening all along. It will end as soon as we have a product to sell.
Regarding Dr.M's not partnering, I fully agree with Dr.M's stated partnership philosophy. Only partnerships needed for production and PD/AD distribution. The production 'partnership' could just be working with a company to reliably supply product at a specified price. A very loose partnership. The distribution partnership would be commission based and would require contract signing etc.
I have seen many partnerships end quickly when one side is losing money. So if Anavex cannot stand on its own two feet, don't expect a 'partner' to plug in their profits.
If a large company wants partnership with Anavex...it can have the whole company for the MC of $250M. Peanuts for an Esai or Merck.
Dont expect any details of partnerships, without good PD or AD news. Partnership news is rarely released when there is no product.
I am very happy with Dr.M's performance. My only disappointment was with the 3 trials that were delayed. That is water under the bridge, for the most part (opportunity cost), as we are past that today.
I offer the following caveat for A2-73 trial expectations. A2-73 was never expected to cure anything. It is a CNS homeostasis drug, which is expected to lead to CNS improvements, but not necessarily CURES. For example Rett is a genetic problem, which cannot be cured by A2-73, but it appears to improve the patients lives. AD patients on A2-73, showed cognitive improvements in certain subsets of patients, which has been thoroughly documented. Hopefully similar, or better, results will be seen in the PD patients endpoints.
I calculated (and posted a few weeks ago) an Anavex PD success value as a SP = $50. We must all do our own risk reward calculations.
Hang in there Jimmy. In two months we will have the results.
Lima, also no recent dilution WHILE KNOWING THE COSTS ARE ABOUT TO GO UP BY ADDING A NEW TRIAL!! That on top of a lot of trials already underway!
Why no dilution?
Could be bad news is expected? NO, as TGD would have diluted at recent sp prices, before the sp goes down!
Could be good news is expected? YES, sell at HIGHER SP!
Positive PD results could also help Linda Ronstadt, who suffers from PD. It stopped her singing. That would be wonderful to hear, as well as a $50 SP.
Lol. Need to do the trials for drilling and draining the plaque.
AVXL stock price with positive PDD results is:
When Biogen recently claimed a drug with Alz efficacy, their market cap went up $18billion, within a day or two. This is what the market immediately valued an Alz drug at, taking into account PE ratio, sentiment, etc.
Also, there are 5.8 million americans with Alz, and 1 million americans with Parkinson's(PD). Then the market cap for PD should be 1/5.8 of $18B...which is $3.1B.
Given Avxl shares at $3.50 and mkt cap of $217M, (3.1/0.217) gives a potential SP of $50.
With positive PDD trial news, Avxl share price could go to $50.
This is a back of napkin calculation for risk reward thoughts. So, if there is NO success in the PDD trial, maybe the SP goes to $4 or $3.5?
As a side note, these figures have been discussed within my investment group as well.
Thanks JSTM. Adding to that,Fauci said...
----
Investor, regarding the accuracy of the doses you mentioned in the EMA registry, who knows? Apparently, the good doctor seems to leave all dosages defined in public registries open to question. Does anyone know how strict registry data must be? The timeliness of the updates is pretty loose as well.
Dr.M is using High and Low doses as "place holders". They are trade secrets, hidden for the interests of the company AND shareholders.
True for both Alz trial and PDD trial.
Or to quote Dr.M,
"...Don't specify the dose because we want to maintain complete blinding."
Also, as patients come off trial, dosages can be completely different levels, as has been discussed here.
Dr.M is using High and Low doses as "place holders". They are trade secrets, hidden for the interests of the company AND shareholders.
True for both Alz trial and PDD trial.
Or to quote Dr.M,
"...Don't specify the dose because we want to maintain complete blinding."
Also, as patients come off trial, dosages can be completely different levels, as has been discussed here.
Bio, good observation. Re your statement that some might say that CM is searching until he finds a positive indication... I say, so far, he has ONLY had positive indications on everything he has tried (AD and Rett)!!
PDD tbd
Over two weeks ago, it was reported that U.Minnesota and NY were both studying hydroxycloroquine (HCQ) affect on covid patient. One had 1000 patients, the other 1500, I forget which was which. Two days ago, it was reported that Washington also had a HCQ study underway. Results from the first two should have been ready days ago.
Yesterday, Hahn, head of fda said it will take several months to get the results! huh?! He is perfectly willing to let 20 companies start trials on their 20 new drugs, and say they will take several months for results too!! Umm, one drug is available right now!
Why does it take fda so long to get results from the hcq dosing, that has been underway for weeks now??
HCQ IS GENERIC! So no money behind it! That explains a lot! But still why does fda seem to be unwilling to lift a finger to at least get the hcq data from ny and u.minn, immediately? Why is fda not coordinating these real time tests? Just looking the other way, and waiting for the BP trials to run.
FDA does not appear to be leading at all in this fight. They look like an inflexible beauracracy, going through their usual motions, while people die.
UPDATE -- I called Investor Relations....
I asked about the PDD and Rett trials. IR says no testing sites are affected by the Chinese virus to this point. If there is a disruption, there are other avenues in place to get medicine to people.
There will be a 100% Enrollment PR for Rett, when that happens. The thinking is that the virus has affected enrollment for Rett.
They now expect to have both Rett and Pdd results, at about the same time, this summer.
Wrong. If anyone in u.s. suspects they are infected all they have to do is call the local health department or their doctor.
Steady, it appears to me that in the efficacy trials (with placebo arm), a2-73 is given in low to medium doses, so there are no problems with dosing being to high, messing up the dosing regimen.
Then the EXTENSION trials are where the dosing is really varied to obtain a plot of efficacy versus dosage. Seems like a safe way to handle dosing, though it takes a little longer because of the extension.
Bas, interesting thoughts. Thanks for the perspective.
Grim, post chart so I can learn how to paper trade avxl too. Very helpful. Thanks
McG, only 1270 5$ call options tomorrow, so that little amount would not motivate price manipulation down to 5$ (imho) as millions of shares sold yesterday. I interpret the price down yesterday as anavex selling stock to raise cash. I suspect anavex got their fill of cash, and hopefully we will not see much more selling from them for a while. Likely, there was also a falloff in buying as well.
In the run up to 6$, it is possible there was some shorts covering, but there are >6million short shares, so there will need to be a LOT MORE COVERING, which is probably yet to come.
Leo or optionexperts, please check me on this. I might be on same page...only 1270 5$ call options tomorrow, so that little amount would not motivate price manipulation down to 5$ (imho) as millions of shares sold yesterday. I am not an option guru so tell me if I am wrong.
Thus I interpret the price down yesterday as either shorts selling or anavex selling stock to raise cash. Somebody had to come up with a lot of shares to sell!? Millions of shares traded, so I tend to think it was NOT shorts, as that is a huge amount. So that leaves anavex raising money. Do you agree/not...anyone?
Nidan, at least it appears that fda is not giving Biogen a pass, but requiring them to trial and prove, the claim that they have some evidence of efficacy.
It looks like biogens pressure on the fda, to just approve, did not work. Fda passed that test.
Reasons for no A2-73 peer reviewed article...
I was very disappointed to learn there would be no peer reviewed article. I was looking forward to seeing all the most recent data and have many details explained.
I think the reasons it was not published are as follows:
It seems that, almost monthly, the understanding of the science of a2-73 efficacy increases. Not just s1R, but homeostasis, autophagy, gut biome, gaba/glutamate, etc.
Because of the ever increasing understanding, Dr.Missling probably did not want to publish, as it would appear to be published early, before the knowledge/project was complete. Scientists do not like to publish partial results!
Also within 6 months (at the time) rett and PD trial results were expected, and the results would generate the desired PR/interest.
Also, companies are sensitive to publishing their R&D results for the world. There is little upside, and the downside is the releasing of what are called 'industrial secrets'.
Lastly, the team has been busy preparing trials, expansions, partnering, etc. These efforts obviously should have higher priority!
I know interest has waned, on this subject, but I wanted to publish my thoughts. Xena might include the topic when she writes her book on the great success story of Anavex!
Investor exactly, anavex knew little about why a2-73 worked only a few years ago. It was just homeostasis. It seems like every month the understanding of the reasons for efficacy grow. Mitochondria, autophagy, gut biome, Gama/glutamate, etc.
Well said!
BB, yes that is the way the oles are. Evidence the recent news reports out of the ALZ study in Australia. The trial is still ongoing but the original patients that have completed are now reading AGAIN etc. THE FLAMING BUY signal.