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Thanks for sharing. I believe the mystery indication is ALS based on Dr. Missling's comments.
The way I understand it, submitting Avatar alone was a bit of a risk -- even though the data was good, there was so much uncertainty based on the "goal posts" arguments made by Feuerstein and others. Positive Excellence data submitted alongside Avatar provides a more robust NDA for the FDA to review.
With the FDA you only get one crack at approval most of the time, so I don't mind the delays if they will help improve Anavex's odds of approval down the line.
There's a group of "regulars" who I remember migrated from the old Yahoo board. I cannot remember if you were part of that group, Leo, but if memory serves me correct I believe you were.
This is probably an accurate estimate. 2024 isn't too far away. Remember back in 2018 when some people thought that FDA approval was imminent? Everything takes longer than expected when it comes to the United States government. But if Anavex is the real deal, the wait will have been worth it.
So it's probably about the money then. Everyone has a price.
My opinion is, who cares? It doesn't seem like Anavex needs him. The SAB is kind of a joke at this point anyway -- the drug is at the finish line of the trials and if successful, I'd rather have warrants and options going to those who are actively working to market and sell, over those whose job it is to "advise...:"
Typo. My point is valid though.
Eisai is a much bigger and more prolific company than tiny Anavex. I don't blame anyone for taking that sort of opportunity, nor does it have any influence on Anavex. Blarcamesine doesn't start or stop working based where he's working.
There are three likely reasons why Dr. Hampel left Anavex for Essai:
1. More money
2. More prestige
3. More likely to win FDA approval
I know a guy who played some professional basketball overseas. Star of his team, everyone loved him. One day he ran into an NBA scout who was on vacation with his wife during the offseason and who remembered scouting him when he was in college.
A few weeks later he gets a call with an offer to join the NBA's D-League. The pay wasn't much better, but anything with NBA in the title was automatically more prestigious and it offered him a more direct chance to pursue his ultimate career goal.
My guess is that Dr. Hampel found himself in a similar situation when a major league pharmaceutical company offered him a job he couldn't turn down, because the alternative would have been continuing to play in the minors.
That or he saw data he didn't like and decided to jump ship.
How do you figure $100/share?
That is nearly $8B for the market cap. I don't know that Rett alone warrants an $8B valuation because there simply aren't enough patients to produce the sort of revenue and cash flow. Even if insurance companies do cover Rett, they're going to negotiate a massive discount on the "retail" cost of Blarcamesine treatments.
why wouldn't Rett be the first catalyst?
That was the algae stuff that was supposed to cure Alzheimers? I vaguely remember it being a point of discussion on this message board. In the 7+ years I've been invested in Anavex there have been lots of drug compounds to fall by the wayside. Whatever happened to AXON and its wunderkind CEO?
Maybe Anavex could go the Herbalife route? Those mid-level marketing businesses make a TON and nobody ever questions or cares about efficacy.
If Anavex fails to meet the primary endpoints, I’d mind to see them pivot and sell Blarcamesine over the counter as a non-approved supplement sleep aid at Walgreens.
Valid point. I was lazy but FDA could be swapped out for any other foreign regulatory agency.
My point was more that CEOs of large pharmaceutical companies aren’t going to partner at this stage. They either want to get in early and pay very little, or get in late and pay more when there’s no more risk.
Currently, in the middle of these late stage trials, the cost to partner or acquire Anavex is high but so is the risk. No CEO will jump into that risk/reward scenario with open arms.
I hope so!
Thanks. This does not sound like it will bode well for Anavex when it has to present data to the FDA, unless there is a very good reason for changing the endpoints.
The saving grace may be the lack of other effective Rett treatments, but it seems a bit sketchy they aren't releasing the original endpoint.
I really need to start following this company more closely but these trials take so long. I admire those who are able to stay invested -- no pun intended -- in the various updates day in and day out for so many years.
As always, I appreciate your perspective.
I hope you’re correct! My experience with insurers is that they’ll do anything possible to take in premiums and will do even more to avoid paying claims. I have a feeling all will hold out as long as possible until one finally agrees to cover it and the rest fall in line.
The cost of covering it may be less than the cost of not covering it and letting people suffer, but that’s a societal cost. Insurance companies only care about their bottom line and if CNS disease is as prevalent as many say, insurance companies are going to have to get used to paying more than they’re used to. Most likely they’ll just keep raising premiums for the rest of us.
I haven’t paid much attention to Anavex recently. Why did they change the endpoint for Rett?
Partnering would make it more difficult to attack Anavex. It’s easy to go after a small fish in a big pond. If Anavex partners with a larger company, it discredits those who try to distort the data for their own benefit.
All that aside, it’s important to at least begrudgingly accept the possibility that Anavex won’t succeed and Adam Feuerstein and his cohort will get bragging rights. Nobody knows how this investment will play out until the FDA makes a decision. And my guess is that most partners aren’t going to show any serious interest with a serious offer until there’s a guarantee they’re buying a drug that is allowed to be sold in the United States. Partnering for $1B+ and then seeing Blarcamesine not approved is a one way ticket to the unemployment line for a BP CEO.
Who cares if they write hit pieces? The only opinions that matter are the FDA experts. A well-timed hit piece full of slanted information may have a short-term adverse effect on the share price, but as long as Anavex isn't trying to raise more cash it doesn't really matter to anyone other than traders looking for a quick exit.
Before Jesse B, it was some other Twitter scientist. I can't remember her name. Before her, it was Nathan Michaud, and before him, Jean Fonteneau. Anavex investors should be used to these types by now and factor their influence into the short-term price action.
My fear is that healthcare insurers will be initially reluctant to pay for Blarcamesine.
Interesting link to the interactive site. Thanks for sharing it.
I agree that in the end the only thing that matters is safety and efficacy in properly conducted human trials.
But it seems to me that many failed drug candidates initially had mice or rodent trials that went well enough to justify further trials. This is why I have a difficult time becoming too excited over A371. It looks promising, but the murine tests are so preliminary that it's nearly impossible to say that they mean anything other than further investigation is needed.
I'd much prefer a successful murine trial than a failed one. But as you may or may not recall, many investors were ecstatic about Anavex's P2A trial in July 2015. According to them, approval was two or three years away. We're now going on 7+.
A371 may be the future but for now, my hope is that Blarcamesine gets approved because without recurring revenue, there may not be enough of a runway to finance the A371 tests through to completion without significant dilution to existing shareholders.
Good analysis...but one question for you that has always been on the back of my mind. What happened with all of the other drug trials that presumably involved mice and warranted further study, only to later fall apart in P2 or P3 testing? Why do some mice models accurately predict success in humans but others do not with regard to Alzheimer's trials?
This is mostly correct. Sometimes large funds recognize they are late to the game, or that an upcoming catalyst is imminent and they’ll try to acquire cheap shares by “shaking the tree” and seeing who will sell to protect profits or minimize losses. Once they’ve taken a position the stock price will begin to climb toward intrinsic value.
But that’s not what happened yesterday. Anavex was the victim of bad timing. A forced Sunday PR because of a weekend presentation + an overall down day in the market led to reduced momentum as money went to the sidelines as fears of recession grow stronger.
You are correct that had this news event been a revenue defining moment it would have had more buyers than sellers. The fact that Avxl closed red doesn’t mean the PR data was negative or unimportant. It means that the data was not urgent.
Less sophisticated investors and most traders fail to understand the distinction.
Nope. Just realistic. Everything takes longer than expected. So when the cheerleaders from the balcony are shouting $100 in 6 months, I'll say it's closer to a few years.
Maybe you weren't around when people thought January 2018 was going to be a significant month for Anavex and FDA approval. Or when people were saying $1000+ back in November 2015 when it spiked to $15?
The fun thing about predictions are that they're easy to see who is right. What are your realistic timelines for share price appreciation?
Eventually people will realize that irrational exuberance leads to disappointment, such as the fact that Anavex is now down for the day.
Long-term yesterday's PR announcement was a positive for the company's future. Anavex is taking its time and being methodical, much like the FBI often spends months or years building a case before it makes any arrests. Lots of impatient investors who want immediate returns cling to false expectations. This is why I ignore those who insist Anavex will be $1250/share -- if that happens, big if, it's 7+ years away. Triple digits is most likely 3-5 years away.
I am willing to wait to see how it plays out. With each positive PR, the risk diminishes slightly.
That guy was the biggest fraud in town.
There is no link because there is no sales director job currently available.
The problem is that there are so many positive (and real) developments to discuss, but instead there are discussions posting misinformation designed solely to trick new investors or give a false sense of premature optimism.
Except they're not hiring anyone for that position. At least not yet. But as Lennon once said, believe whatever helps get you through the night.
No, they don't have to advertise for a sales director. And they aren't advertising a sales director. The available openings at Anavex are clearly listed -- and sales director is not one of them.
Except Anavex is not hiring a sales director. At least not yet. That will be down the road after FDA approval, once it has a product available to sell.
The stock isn't moving? It was in the $7s last month. I'd say there's been decent movement over the last month.
It'll take positive FDA results to reach last summer's highs. Last year money was being passed around at unsustainable levels and everyone was in party mode. I don't see that environment returning anytime soon.
If you're a trader, Anavex is a boring opportunity because of the long time it takes to properly run a trial. If you're an investor, waiting until 2025 or even 2030 to see this through to the end is not a big deal. So far everything seems to be progressing smoothly.
I'd bet that there isn't a single drug that's ever been approved that didn't have some group rallying against it, trying to distort the science or accuse the company of mismanagement.
You use the rare disease to get the pediatric voucher to accelerate the profitable diseases. That's the focus point. Otherwise Anavex submits to the FDA and the application just languishes for months and months.
Good to see you back here as a voice of reason. Everyone is looking at the 5 day chart and panicking. If they looked at the 6 month chart they'd realize everything is copacetic.
There you go. Even longs are a slightly reluctant to buy in right now. Me too, because the drop from $13 to $11 is fairly insignificant. It wasn't long ago this was at $7/share, and a lot of money I believe is on the sidelines right now.
Everyone clamoring for a PR announcing the completion of the trial is shortsighted. Odds are any pop in the share price will quickly retrace as has every other PR announcement. What matters is P3 data.
I believe that AVXL will be approved for Rett syndrome. There aren't many other treatments and anecdotal evidence supports that the drug works well enough to warrant approval. Whether insurance companies will cover the cost initially is another question I don't know the answer to.
I have the odds of Rett approval somewhere around 80%. I have PDD and AD closer to 50%, which is a nice improvement from the 15% I had it pegged in 2015 when it was still in P1.
Thanks for affirming what I said earlier, that only the FDA's opinion matters.
My point is more that with a stock like Anavex, it's not too hard to control the share price in a coordinated short attack. It's not even that hard for a poster to control the share price without a short attack.
I'd be willing to bet that if MayoMobile or Dadofmarcmax or any of the other 3 or 4 knowledgable longs here posted tomorrow that they were all out of AVXL, the stock price would drop if only because some posters here will develop cold feet, too.
The market is up across the board. AVXL was up the first 10 minutes this morning, then some activity happened on Twitter and now it's dropping.
With low-volume stocks like Anavex, it doesn't take much to move the market. If anything, I think a lot of astute investors are looking to de-risk by moving money into blue chip stocks that are seemingly on sale right now. I wouldn't be surprised if some investors are selling Anavex and moving into more secure positions. The twitter poster is stoking the fire with evidence that as of now, nobody has refuted. Let's see what happens when some knowledgable posters respond with their own set of evidence that supports AVXL's claims.
A PR saying the trial is completed is ultimately a non-event. Everyone knows the trial will be completed soon. It's irrelevant to the intrinsic valuation. Positive data from the completed trial is what's needed. And that will take time to gather.
I'd rather have one haymaker PR announcing positive data than a somewhat meaningless PR that will dampen the effect of a top-line data PR a few weeks/months from now.
Yes. Notice that nobody is responding with evidence that Anavex is not manipulating data? So he keeps posting and the short attack marches on.
The reason the stock price is crashing today is because there's a poster on Twitter who is saying that AVXL is manipulating data. He was attacking SAVA before.
Maybe he's right. I don't know. I've heard a lot of the same arguments in the past and all I can say is that the FDA will be the final arbiter of success, not some low-level scientist on Twitter. It's interesting though that nobody here has discussed his posts and their validity, especially the one where he found a study that questions Sigma1 and M1 receptors.
Anavex isn't hiring a sales director. The dropdown menu is pre-populated with several job positions, sales director included, but the open vacancies are more limited at the moment:
Director/Senior Director, Biostatistics
Senior/Exective Director, Clinical Development & Medical Evidence
Director/Senior Director/Executive Director, Clinical Development
Associate Director/Director/ Senior Director, Clinical Scientist
Vice President, Quality Assurance
Director/Senior Director/ Executive Director, Clinical Operations
Director/Senior Director/ Executive Director, Global Pharmacovigilance
I'm sure Anavex is collecting resumes from people who are filling out applications based on the drop-down menu options but the only jobs that have actual descriptions attached are the ones explicitly cited as being vacant. The fact that Anavex is looking to fill 7 new positions is a read-between-the-lines positive development but hiring a sales team 12-18 months before FDA approval is a bit premature.
Ironically, a stock like AVXL has the best shot at bucking the market because it is still in the pre-revenue stage, which means that future cash flows are all but impossible to predict. Lots of smart people here have made projections but in my opinion they are overly simplified, and back of the napkin estimates should always be taken with a grain of salt. Financial models are very complicated and require a lot more effort than can be summed up in a paragraph or two on a message board.
All that being said, what Anavex has going for it is that the FDA does not stop functioning during a recession, nor do Anavex's clinical trials. When the time is right, hopefully we get the FDA approval we all are looking for and when this happens the stock price should go up no matter what happens to the market.
The upside may be limited though if other firms who are interested in a buyout / partnership opportunity decide they'd rather hold onto their cash.