Anavex Life Sciences Corp (AVXL)

[crescentmotor]

Why do you think Anavex is being blinded from its unblinded AD OLE?

I didn't say AVXL was blinded from its OLE trial. But to get to the crux of the matter, did AVXL conduct, as SAVA did, new baseline data for all participants entering its AD OLE trial? If no, then AVXL is, in effect, blinded to the OLE results even if the extension is technically unblinded. If yes, and if AVXL is doing interim testing on the OLE patients, then AVXL will have data available as to how those patients are doing although that data may not be reported publicly. As an aside, even in a blinded trial, the trial sponsor has access to a lot of trial data. However, the data is blinded as the the treatment arms so the sponsor has no idea whether any particular patient is in the treated or placebo arm. That is my understanding of how it works, subject to correction if that is not accurate.

[XenaLives]

LOL!!!!! The conspiracies are real.

The pump and dump is market wide.

The more valid the tech, the more egregious the manipulation.

[BIOChecker4]

Conspiracy theories abound. It’s absolutely stunning.

I have to admit that after years of reading this message board I really thought I’d read it all. Waves and waves of ever crazier conspiracy theories to explain and excuse Missling’s incompetence. It’s always about the assault on the poor little retail investors by the big bad Wall Street crooks (who no one can ever put a name or face to) taking the stock down so the big boys can load up on cheap shares. And somehow, it’s Adam Feuerstein who is the ring leader. So much grievance!

Of course, it’s Missling who is the hero, the champion, fighting the good fight for all those patients and stockholders. Nothing is his fault. No! He’s the hero. Never mind his incompetence. Never mind his stumbles, fumbles, goal post moving, cherry picking of data, missed timelines, silly slogans, and terrible communications. Missling could shoot a stockholder on Fifth Avenue and not lose any stockholders. Doesn’t that sound familiar?

And the funny thing is that the lower the stock goes, the louder the conspiracy theorists shout. Missling eats this stuff up on his way to the bank to deposit his latest out-sized check and the expense of the suckers who keep pouring money into the stock.

I’d like to believe that at some point people will wake up but I guess that’s too much to expect. So enjoy your conspiratorial nonsense while your losses continue to mount.

[Steady_T]

According to what I read the EMA considered Covid an emergency and so far nothing else.

[boi568]

Why do you think Anavex is being blinded from its unblinded AD OLE?

[tredenwater2]

“I suspect that this was all fairly planned. They drove the price down to force the Russell 2000 funds to sell some shares.”

Wow! I know this was mentioned a week or two ago but never thought about applying this to Anvs. Is this possibly applicable? A double whammy bear raid?

Hmmmm.

[crescentmotor]

All the SAVA claims presently rest on unblinded data.

Not true as part of the Phase II was a randomized placebo controlled six month drug withdrawal trial. In patients with mild Alzheimer's, the largest separation between the continuous and non-continuous treatment groups occurred at the end of the 6-month randomized, placebo-controlled withdrawal phase after which all patients resumed treatment with Simufilam. SAVA has reported no cognitive loss in patients with mild Alzheimer's Disease in patients treated continuously with Simufilam for twenty-four months. Unblinded data starts telling a story once a placebo group gets out to eighteen months or longer because of well established placebo effect over that timeframe. I guarantee you AVXL is anxious to see the results of its unblinded open label extension trial that will provide data beyond twelve months. AVXL may even be holding up talking to the FDA about a regulatory path forward until that OLE data is available.

[ignatiusrielly35]

I think what happens next will depend on how the Russell 2000 rebalancing plays out. Today is the relevant date. The ETFs and mutual funds will have to sell some shares based on today’s price. It’s also possible that the market makers have been short term shorting ahead of the rebalance and have arranged to buy the funds’ shares at which point they will use the shares to cover.

I suspect that this was all fairly planned. They drove the price down to force the Russell 2000 funds to sell some shares.

[k9uwa]

Tom nailed it again. Trading within narrow spread. Will it go UP from here or DOWN. Looking at the last 1/2 hour or so of normal trade day... the shorters Sold probably more naked short shares. "They’d prefer that you bail at the low before they do it." Like many others: That won't happen. Price goes down I buy more shares. Eventually it will rise as it has many times in the past. Then is time to sell at least some of the shares. This time around whenever we begin to rise... probably won't sell. We are getting closer to the Goal Line.

John k9uwa

[tredenwater2]

“Retts is not an emergency, Parkinsons is not an emergency. AD is an emergency.”

Tell that to the parents of Rett patients or for that matter to MJFox. Its ALL an emergency. A little girl going into multiple seizures a day, an adult doing the same or walking around looking to escape in the middle of the night, or a forgetful loved one cursing at you when they dont even know your name, which is the worst? How are all 3 not emergencies? All 3 keep the caretakers/loved at home and up all hours of the. night.

Dr Missling is going for prophylactic use in all 3 and more, just a matter of time.

[bb8675309]

Nope.. Need a $15 billion MC. Then you have a deal for a Company worth $30 billion. Smokin deal only for you.

[BIOChecker4]

We sure did. Didn’t even have to use expensive paint. Used whatever color we could get on sale at Home Depot. Brushes, too.

[BIOChecker4]

Please, retail, sell all your shares now so we and our handlers can buy AVXL at cash per share ahead of the meteoric rise when approvals are announced.

There. I confess on behalf of all corrupt Wall Street players. Are you happy?

[sumbuysumsell]

Your posts were kinda more interesting back when you shared your lunch menu. Hip surgery must have set you back? Hopefully you will be able to get out for a bite soon.
If it helps to get you going, I had chips with humous, bacon, and mint chocolate chip ice cream for lunch with the 5 year old granddaughter. Afterwards, she painted a picture of pelicans at the beach.

[georgejjl]

The bashers, FUDsters and shorters painted the tape at the close of trading today!!!

Good luck and GOD bless,

[bb8675309]

Yea. It's ridiculous how much money they have taken out of this company. Best in class cutting edge CNS company on the market trading at a MC of $300 million.

[ignatiusrielly35]

The same parties have no problem manipulating or riding it the other way. They’ve done it before and they will likely do it again. They’d prefer that you bail at the low before they do it.

[bb8675309]

Yea, you can't win because it's corrupt and the retail investor no longer has any protection.

[BIOChecker4]

Nobody is forcing you, mauismart, Xena or anybody else here to put money in the stock market. If you really think the stock market is so deeply corrupt, sell your stocks and invest your money elsewhere.

I’ll never understand why people who think like you, mauismart, Xena and some others do nevertheless invest in the speculative side of the stock market. You can’t win, so you might as well buy treasury bills, municipal bonds, or dividend stocks and earn some income.

BBIA (bye bye in advance).

[frrol]

The company has laid out its intentions in the US: based on the FDA's draft updated AD guidelines, we intend to file an NDA with the phase 2b/3 data. Missling recently said to "stay tuned on this", so we are likely awaiting feedback from the FDA on whether they'd be receptive to our NDA. They may not be, but there's a chance. The two biggest remaining stumbling blocks after the ADL failure was mooted would be our relatively small trial size, and the pTau biomarker data that is apparently supportive (down trend) but inconclusive (not stat sig). It depends on how aggressive the FDA still is on expediting AD therapy approvals. We are not on Fast Track, so their response may be just "we'll give you FT, go get a full phase 3 done." Let's see, should hear fairly soon.

[frrol]

And defensive

[123tom]

I've put the clown on ignore now. Like many people have.

[samk]

probably time is money.

[bb8675309]

Your right. They naked short sell the stock and steal from the company value and at the same time billionaire is paying these bashers saying " Hey look over here at the CEO" while in fact they are assisting, robbing the company value. SEC is shett..No protection for the retail investor. Whole market is Fubar corrupt.imo

[Hosai]

IMO I'm guessing Anavex most likely recieved mixed/ambiguous feedback in regards to applying to FDA in 2023, especially in regards to ADL end point. Missling was perhaps going to wait for OLE data and/or the peer review (perhaps even hoping for the peer review to in part make the case that ADL was difficult to show in early AD trials).
Now with the change in FDA draft guidance if all this was the case that it seems things have obviously changed. Perhaps companies might still want to wait for the guidance to become official? Either way it would seem AVXL could apply to FDA anytime...they said they went with EMA first because that process takes the longest and the EMA pr's came out of nowhere last time so there may not be much warning beforehand.

[powerwalker]

No, Joe, those are cicadas!

[TWilson07]

And saying it a second time after the first was deleted isn’t?

[frrol]

Your response is compulsive.

[JoeBear906]

Retts is not an emergency, Parkinsons is not an emergency. AD is an emergency.

[Steady_T]

The FDA has a rolling submission process for drug granted Fast Track designation. So far Anavex has not applied for Fast Track or Priority Review for AD.

The EMU utilizes rolling submission only in emergency health situations.

[JoeBear906]

I want an NDA for AD to the FDA so bad I can taste it. Let the FDA try to say no. It is a drug that likely at least marginally improves the lives of millions with no consequential side effects nor delivery issues. And the recipients are in the end of life. And getting worse quickly.
At worst, under right to try, at least with provisional approval with a concurrent phase 4 review leading to full approval and full medicare insurance coverage.
But Anavex simply must submit an NDA for AD. And for god's sake adult Retts too.
Remember the 12 sections have at least 4 sections that are the same between AD and Rett's.

[JoeBear906]

Pre-approval process. Hmmm. It has multiple sections, the NDA has 12. The MAA probably has a similar quantity.
I am thinking Anavex could listwhat it has submitted such as 'We have sent in sections 1 through 4 of 12' without a lot of controversy or 'We have begun submitting sections of the MAA.'
I can't see how announcing that would be actionably bad. It sure as hell would be share price good for selfish old me and the company that wants to raise funds through already planned and announced dilution.
But I hear only crickets.

[frrol]

You meant to write they have yet to show stat sig efficacy in a controlled trial. That would be a sensical and true statement.

(They had a small controlled trial readout last year.)

[123tom]

Watch the price action , clown. See if it's understandable to you. If you don't understand what it's doing, read my descriptions. This is my last attempt to help you stop your mind game. Good luck.
Today's tight range between 3.55 and 3.75 is the battle zone I described. The small but significant rally over 2 days, from 3.25 to 3.75, didn't continue today. It has to try again tomorrow and this week, as Price won't stay at 3.65 for too long before it makes the next important move. Important for shorts and longs. Because shorts have to stop continued rally now, or else they'll be looking at prices around 4.00-4.50 . Would they be ok with that? Conversely, longs have to rally again now and break through this 3.70 barrier, can't stay stuck here or shorts can roll it over and send price tumbling down again. So, right here is a key battle zone for the price action. Target up is 4.35 area. Target down is 2.90 area. But this next move starts here in this 3.50-3.75 zone.
The stronger trading force, mm manipulation, computer bots, or eager investors, will demonstrate where they want the direction
to go this week, continue downward, or develop the bottom at 3.25

[skitahoe]

I don't believe that has to be true. Remember, I'm not saying for every trial, but if the DSMB or lead clinician believes such action worthy, it could take far less action at that point to make such a decision than waiting years and reviewing applications that run to over a million pages. I believe a fairly small panel of expert Drs. actually seeing what's happening at key trial sites would take a smaller effort than evaluating a BLA or NDA as applicable.

Gary

[skitahoe]

You're right Joe, I was suggesting a massive change, I don't know if it will ever be made. I'm sure we've not yet had a filing with other regulators as if we did, it would be announced. They're preparing to do so, but that can take a great deal of time, I have no idea just how close they are.

Gary

[boi568]

All the SAVA claims presently rest on unblinded data.

[crescentmotor]

He also posits that the benefits of Simulfilam evaporate after 18 months, so don't get carried away.

True--but that is for unblinded data with looser patient entry criteria than the two Phase III trials. I also did not did deep into Bio Scoping's analysis or his SAVA PR sources to see how things like patient drop-out numbers were handled. For now, SAVA appears to be setting the high bar as no other AD drug that I know of provides positive benefits for so long. Let's see if AVXL can do better when it releases some eighteen month OLE data. The biomarker data between the two companies will also require comparison. Game on!

[frrol]

Your horoscopes give horoscopes a bad name.

[boi568]

Anavex is in the pre-application process for an MAA.

[boi568]

If the FDA were to involve itself in ending trials for efficacy, as you suggest, it would requires orders of magnitude of greater resources. This is not going to happen.

[123tom]

Brief price action comment for today...
Yesterday's bounce peaked at 3.75, pulls back to pivot at support 3.55, and bounces to a key step Resistance at 3.65. This is the battle zone I described in recent days. The place where resistanceover and and selling could make price roll over and start the next downwave. This is a battle zone at 3.50 support, 3.40 support must hold in order to keep any rally momentum, and maintain 3.25 as a Bottom. Watch this battle zone. The winner could see an 80 cent trade target. 4.30 for bulls or 2.90 for bears.

[boi568]

He also posits that the benefits of Simulfilam evaporate after 18 months, so don't get carried away.

[JoeBear906]

I really wish I had won a million dollars. I really wish I won the lottery. I prayed hard. And one day I heard in meditation a tiny voice deeply intoning...."Buy a ticket!"

Anavex won't get any kind of approval without an NDA.

I am not even clear the new drug application has truly gone in for the EU EMA MA.

Anybody know?

[skitahoe]

Thanks for all the agreement, but sadly we cannot change the FDA or other regulators without immense pressure for change. I believe our FDA has become a little more open to change, but far from actually getting involved in trials and making a judgement for themselves without formal documentation that often goes over a million pages and adds perhaps a year or more to the process. Imagine the difference if the DSMB at 50% or so through a trial told the FDA to come take a look at what's happening here, and if you like it, approve it, or at least permit it's use for sale by granting EUA for now, with further results supporting full approval through a Phase 4 reporting the results of all who received the product.

I suspect that such actions would cut the cost and time required for many approvals dramatically, certainly approval with out a ton of paperwork would save years, and many millions. I also suspect that our regulators would get a far greater sense of accomplishment if they actually got involved in the clinic instead of reviewing a pile of data. JMHO.

Gary

[Investor2014]

Let's see Anavex actually filing for approval before worrying about all sorts of at this point immaterial concerns.

[crescentmotor]

Bio scoping on Patreon

Bio Scoping (Piotr), a long-term AVXL holder, has long viewed SAVA with a jaundiced eye. Now he has transitioned in a fresh analysis that shows SAVA's Simufilam cognition effects at eighteen months are 3X that of the approved drug Donezepil (Aricept), which only shows cognitive benefit for six months, and that his analysis points to a favorable Phase III trial outcome. The blinded Phase III outcome can be anticipated to show even better results due to more stringent patient eligibility requirements than existed in the Phase II trial. In a vote of confidence, two SAVA directors have just exercised warrants and collected put up $5 million out-of-pocket toward additional shares. Still waiting to see if the CEO exercises any of his warrants prior to the May 6 final redemption date.

[ExtremelyBullishZig]

George...what do they know...?

The price just doesn't skyrocket like this for no reason...

[Talon38]

Gary...your positive logic is right on. Anavex trials have proved 2-73 has efficacy against deadly and debilitating diseases and it is very safe! In the meantime, due to the length of the prolific trials and their bureaucracy...people die as a result of those diseases. The very goal of being very safe in the development of drugs can take a very dear toll. The example of the development of COVID vaccines was...."time is of the essence". The FDA, EMA and other national health agencies need to accelerate cures while they insure product safety!

[powerwalker]

old*, there have been many posters on this MB that have advocated the same thing for years in different terms before this guy showed up with his "AI" generated type postings.