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So say you. Again, you are speculating. Not facts, just IYO.
We are looking awesome heading into the end of the year! Upcoming catalysts are lined up like nerds at a Sci-Fi convention.
This is a great time to be in this stock. All serious Longs have done (and continue to do) their DD. Now it's just a matter of sitting back and watching events unfold in a way that gives us a good reward.
Critics love to talk about the future. Nothing but the future and what they "guess" won't happen in the future.
Serious, sophisticated investors look at the past as well as guessing about the future. Their guesses are based on sound reasoning based on established facts. Established facts require no guessing. They are solid, real.
I would beware of anyone who only wants to critique future events with no evidence to support their ideas.
So your "facts" that you are basing your skepticism on are the fact that you are guessing we don't have time to get the enrollment started before EOY?
Again, you are guessing about what the future is going to be. You are accepting your guess as proof?!? Get real!
I also appreciate how you aren't arguing about 2-73's successes so far. Good to see you accept that fact.
I will keep trusting my guesses about the future instead of yours.
You are still talking about the future. You can't say things won't happen till they don't. You are guessing. I guess differently. I think you are wrong. You think I am wrong.
But the facts that are a part of history now cannot be argued. All signs point to success for AVXL and 2-73.
Sorry. You failed.
We will find out. Predicting the future is impossible. All we can do is go by the facts of what has happened so far.
You are taking an untenable position here. I ask you to present your reasons for doubt and all you can do it start talking about the future. You have nothing to base your skepticism on. No proof. Not even any fact-based line of reasoning. You just keep looking at things in the future to cast doubt.
We'll give you a mulligan on your failure the first time. Try again. Really. Here's another chance for you.
Tell us what has happened SO FAR that causes you to doubt the future for AVXL. Not things coming up in the future. Give us facts.
Maybe for those giving a passing glance. But if you understand the science and take the results thus far for what they are (being fair, honest, and diligent) there are plenty of indications that point to success.
However, it is not easy to find any evidence that seems to portend bad news ahead. The oft regurgitated "n32" is not evidence. As aren't "Missling's salary", "99% fail rate", "no placebo", etc, etc, etc...
All of that gobbetygook is not any kind of evidence. It's like someone saying "I have proof that you committed a crime."
You say, "No I didn't! And you won't be able to prove it!"
Their response is, "Then prove that you didn't!"
There is solid science, repeated by several different entities, which indicates 2-73 seems extremely promising for several diseases. This is not arguable.
We know that the company is proceeding with scientific presentations to show off their good progress being made. This is not arguable.
We know that the Rett trial is going to start very soon. This is not arguable.
The company is proceeding according to the plans they have made public with a good track record of following though with promises made. This is not arguable.
Although the primary endpoints wer safety and establishing max dosage, the EXPLORATORY efficacy data collected points in the same good direction that all of the earlier pre-clinical trials did. This is not arguable.
So what, "Sir", is the proof that you say is causing you to show a pessimistic outlook for the future?
Who said they (or anyone for that matter) were claiming that??!
There is overwhelming evidence for being optimistic. There is extremely little to zero evidence to support a pessimistic attitude.
Evidence for optimism is not the same as evidence for efficacy. Get real!
Man! I'm so looking forward to a cleaned up ihub board. Please release the bombs Dr Missling.
Shut up the low-information Posters.
This conference is too late for our schedule. I don't see how we can get three trials going this year unless we start earlier. Something's gotta give here.
Either we don't start three trials this year... or we don't release PK/PD before starting... or we have to release data NOT at a scientific conference...
I don't think we can do it all unless we bend on something.
My question is whether we will get PK/PD data or an update on the 2a trial. The abstract does talk about AD.
I know it's not the perfect venue to release scientific data, but I don't see an upcoming scientific conference that would happen at the right time for AVXL's schedule.
Not sure. I noticed this on the website yesterday. Didn't get a PR today.
Very cool! Paid $4.54 for them too!
On May 22nd AVXL released data regarding preclinical testing for several diseases. The results were astounding. There is just too much "converging evidence", as Missling puts it, to ignore the obvious conclusion:
It works!
Check out the study if you haven't already:
https://globenewswire.com/news-release/2017/05/22/994557/0/en/Anavex-Life-Sciences-Reports-New-Data-for-ANAVEX-2-73-in-Neurodevelopmental-Disorders-Including-Angelman-Syndrome-Data-Presented-at-Antiepileptic-Drug-Trials-XIV-2017-Conference.html
Here are my favorite parts:
Angelman Sundrome:
"ANAVEX 2-73 administration significantly reduced audiogenic-induced seizures"
Fragile X:
"ANAVEX 2-73 has previously been shown to normalize an array of behavioral impairments in a mouse model of Fragile X"
"ANAVEX 2-73 restored hippocampal BDNF expression to normal levels (p<0.05). BDNF under-expression has been observed in many neurodevelopmental and neurodegenerative pathologies."
"ANAVEX 2-73 normalization of BDNF expression could be a contributing factor for the positive data observed in both neurodevelopmental and neurodegenerative disorders."
Rett Syndrome:
"MECP2) mice demonstrated fewer automatic visual responses than wild-type mice. Treatment with ANAVEX 2-73 (30 mg/kg/day PO) for four weeks significantly increased the automatic visual response in the MECP2 Rett syndrome disease mouse"
"A trend was observed in MECP2 mice treated with ANAVEX 2-73 – that is, a reduction in apnea counts to levels comparable to those observed in wild-type animals."
Are you taking everything into consideration when you say $6? I mean patent, PK/PD, 104-week update.
I ask because if you believe what the company has communicated so far, we should see all of this before Rett trial starts.
At what point will A2-73 get a real name?
Results were not very good. Only 15%-16% improvement over baseline. And that was at the highest dosages. They had some problems with AE's as well.
I am by no means an expert on this. Wayyyy out of my league. But I found this explanation online:
"Locus coeruleus cells are not dying, but are more likely losing their fully mature phenotype, since no apoptotic neurons in the pons were detected.
Researchers have concluded that "Because these neurons are a pivotal source of norepinephrine throughout the brainstem and forebrain and are involved in the regulation of diverse functions disrupted in Rett syndrome, such as respiration and cognition, we hypothesize that the locus coeruleus is a critical site at which loss of MECP2 results in CNS dysfunction." The restoration of normal locus coeruleus function may therefore be of potential therapeutic value in the treatment of Rett syndrome."
Reading this I surmise that what seems to be happening is that the genetic flaw is causing a breakdown in the working of the neurons in a very specific place in the brain. This flaw is not DIRECTLY involved in the dysfunction. It is one step removed. If you can alert the cells to the problem happening upstream they might be able to compensate and restore homeostasis.
I think they have been burned in the past too many times. They have released data piecemeal as it came in and each bit of good news was twisted and bent to look bad by the (e-hem) "people who do that kind of thing."
They are getting all the analysis compiled. They are making their air-tight case for 2-73. They are going to come out both guns blazing this time.
Not only will we get great PK/PD data... not only will we get a great update on the 104-week extension... not only will we get a patent announcement... we will also announce the start of the Rett trial.
All at the same time (or close to it)
The response from "pessimists" will be weak and ineffective. You can't argue with success. Mountains of great data will be backed up by a new trial starting.
Nothing to nit pick. Oh... they'll try! But it will sound very impotent.
That's what I think we should see. Just a guess though.
Missling bought 750 shares the first time. Every purchase since then has been half that amount (375 shares). I think the signal to look for is another purchase of 750. I feel that we will see that as the final purchase before something big happens.
Yes you did.
What you failed to see is that the current trials are for safety and dosage only. This has been well established by the completed phase 2a, part b trial.
We have only collected efficacy data as a secondary consideration so far, thus the reason for the small size of the trial and no placebo control.
Safety is a done deal. This will simplify development of 2-73 for other indications. The road is smoothing out before us.
We are talking multi-Billions in valuation if Rett goes well. Based on validation of our approach.
When we get data from the Rett trial (around Feb '18 at earliest IMO) where will we be?
We will have trials currently running for AD, PD and (possibly) MS. With success in Retts it would be speculated that the other trials would reap good results as well since the MOA is pretty much the same. There will be a buying frenzy. Price should jump way up to the $2B-$3B market cap area at that time.
If PD data (which should follow quickly on the heels of the Rett data) is positive I think we shoot straight to $5B-$8B. That's because we should by that time see some kind of indication from FDA about what will happen with Retts approval.
If all of that occurs, I'd expect initial interim data readouts from AD around that time. If they are on par with previous results I think we shoot straight to $10B minimum.
During all of this is think we will probably see some kind of partnering happen. The details of that will dictate where we would go from there.
If the trial data continues in the same trajectory as it has shown so far... my gosh!! Buckle up!!
You are spot on!
Don't take the following to sound harsh or cold. I want very much to see the end of this disease. I can't even imagine one of my daughters in this condition. Very sad. But here's how the business side of it looks to me:
From what I could find Rett Syndrome affects 1 in 10,000 to 22,000 females in the U.S.
If you take the average of this estimate you get 1 in 16,000 females in the US. US population is about 323 million. So we get about 10,000 female Rett sufferers in the US. We can estimate 75% of patients being prescribed (conservative IMO).
If we figure a monthly profit of say $200/patient (this is very conservative as well I'd say) we get monthly profits of $1.5M and yearly profits of about $18M.
These are just numbers based on the US. Actual worldwide profits would be much more.
Here's another thought...
Boys usually do not make it to term with Rett. They are either stillborn or die within days of birth. The genetic flaw is deadly to males.
What if genetic screening could be done pre-natal to identify the problem? Is it reasonable to think that maybe 2-73 could be administered pre-natal and could possibly preserve the male Rett babies??
I'm not investing because someone told me to. I'm investing because the science is sound and the results are solid and astounding. This is the same reason I would never sell based on a basher doing what comes natural to him.
AVXL doesn't need pumping. It's the real deal. Optimists here are simply reviewing knows facts about the drug. The results so far are astoundingly good.
As a result, for those who are not closely following the data and don't know all of the science involved, discussing the results we have seen so far may appear to be pumping. It is not.
The questionnaire has some interesting points to glean (obviously, don't actually submit the questionnaire unless you want into the trial)
For instance, question #4:
"Is your child with Rett syndrome able to take a small amount of liquid formulation (tablespoon) of investigational medicine, which can be mixed into juice or applesauce or other light food, once daily?"
Looks to me like the trial is designed already. It's going to happen quickly folks!!
There are lots of things happening in a very short amount of time. I'm sure there are many more things that will happen in the coming months. All good things.
Go AVXL!
6214192051819 1921311 2212020!
Known approaching catalysts:
*Patent announcement
*Sept 11th: CNS Conference
*Sept 26th: Ladenburg Thalmann Conf.
*Oct 30th: Parkinson's Disease Therapeutics Conference
*PK/PD release
*Rett trial starts
*PD trial starts
*AD 2/3 starts
*MTA results/next steps
Other possible speculative catalysts:
*Partnership
*MS trial
*Fragile X trial
*Epilepsy trial
*Infantile Spasms trial
*Cognition in Neuropsychiatric trial
******************************
This is the time to be Long and strong. Don't let your confidence be rattled by nefarious trickery. Hold tight, add where you can, and watch as these and possibly more catalysts occur THIS YEAR. The later it gets in the year the more rapid and frequent the catalysts will come.
THEY ARE COMING BEFORE END OF YEAR.
I thought we all had an unspoken understanding that we wouldn't say it out loud... didn't want to jinx it.
;)
I don't see why the definition of a partnership must necessarily involve the transfer of money. They are working together in a collaborative way. That is a partnership.
No use arguing semantics. The point I was making is that BIIB is definitely aware of 2-73 and it's implications.
Biogen is involved in a partnership with AVXL so I'd say they probably know of Anavex.
It's actually better if the Fud$t€r$ try to keep the price down right now. It will only keep the spring artificially compressed longer.
Once big news hits the launch will be more energetic and go higher than it might otherwise.
Keep it up guys. You are lining my pockets!!
:)
They are not going to run from the negotiating table to write and release a last minute PR. Leaks might happen, it can't be avoided sometimes. That is not AVXL's problem. They will follow the rules and make a timely PR. But it won't come that day/minute/second.
They will announce it after hours or pre market.
IMO of course.
I don't think we will see a PR during trading. We don't need gimmicks. I see Dr M playing it very cool and professional.
It would be very hard to explain to AD sufferers why approval isn't given if phase 2 of the 2/3 looks as good as we have already seen.
Ok. I've verified. I still trust, more now than ever.
Now you getting it. Yes! Missling is handling it in the best way for the company and the shareholders. He has all the info, power, and all the say-so.
I'm glad someone with his kind of good sense is at the helm.
I expect it because the people developing the trial say it is so. They know the most about the situation. More than you or I for sure.