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Good article on the placebo effect.
https://www.nytimes.com/2018/11/07/magazine/placebo-effect-medicine.html
"A decline of 2 points in MMSE over 148 weeks. This is better that SOC, although not exactly a halt in decline."
Considering the age of the trial participants, wouldn't there be a "normal" rate of decline over 3 years anyway?
It seems the FDA is becoming a bit more open- minded.
https://newatlas.com/psilocybin-magic-mushrooms-depression-fda-breakthrough-therapy/56928/
Wasn't there some paper posted on this board a while back showing the percentage boosts A-273 gave to various popular seizure meds?
I must have missed that also.
Could you please repost?
So on someone else's dime the RETT trial is fully funded, likely to completion?
TOO COOL.
Not super relevant but another example of that which ails the human body is, like Anavex, being looked at through newer, different lenses.
https://www.theguardian.com/science/2018/oct/06/race-to-kill-killer-zombie-cells-senescent-damaged-ageing-eliminate-research-mice-aubrey-de-grey
What do you realistically think will be announced/presented?
I'm very happy about Australia and Spain.
I don't trust those in power here in the U.S.
I believe BP could buy Anavex roadblocks.
I'd be really worried if we were a one trick Rett pony.
But we're not.
I was thrilled when I saw the 10/20 dose.
To me, that meant our stuff might work for some stuff way below the mtd.
I agree with some here who've said the PD trial is the big one.
It's short and could lead to money to advance a fascinating pipeline.
I truly would like to see those little girls helped, but the way their wiring is messed up, anything that crosses the blood/brain barrier is probably suspect.
I wonder if Anavex is the only company in the world where the CEO can say this:
"the longer we wait the greater the reward"
And the audience applauds.
Hence the word "inTOXICated".
That's something I'm excited about.
For the first time in years, new people are taking A-273.
Excellent insight!
They've been walking the line for some time now.
They would not blindly utter something stupid.
Reading your thoughts gave birth to one of my own.
If Anavex had taken brain scans of the phase 2a participants at the onset of the trial would scans taken today show reduced Amyloid build up and tau tangles.
More importantly, do you think they will take scans of the new trial participants?
Or do people in the early stages not have much Amyloid build up and tau tangles to measure?
Enrolling the first patient in a gold standard Alzheimer's trial is certainly a cause for celebration.
Cheers All !!!
BB
Poison pill question.
While some retail (like some on this board) are simply buy and hold AVXL shareholders,I'm guessing there are also some who trade the stock while still holding a core position.
My question is, assuming that "first in, first out" type rules would apply, over time do these trader types eventually own no shares that would be eligible under the poison pill provision?
And if that is true, does the poison pill lose slowly lose its effectiveness over time?
He's not going anywhere.
I'm with you on these and a few other points, but the reason I'm in for the long term is the bar to clear is literally at zero, as I believe Xena pointed out.
What we hear (anecdotally) from the phase 2a patients and caregivers leads me to believe we'll clear that very low bar.
Considering their age, wouldn't it be likely a few of them just up and died?
I agree and think this is where Falconer's 2023 scenario is off.
Slowly(painfully so), the world is becoming aware of Anavex.
For now it's mostly academia not the moneyed powers that be.
But with each passing day more will be aware of a small biotech company that is doing the unheard of,
Running 3 separate CNS trials using the same compound.
I work for a cutting tool manufacturer and each year we have a company wide
meeting where they update us on our major competitors and end users.
The world does not operate in a vacuum.
Everyone in biotech land is at the very least aware of us.
I believe if A-273 is approved for PD dementia the investing world will assume the same results for the AD trial.
Fear and greed will force them to do so.
They really don't have a choice even though they think they do.
Human nature is like that.
I also believe approval for Rett will have the same result.
Regards,
BB
I've a question. Not sure how to phrase it but I think you'll get the idea.
As the phase 2 portion of the upcoming AZ trial draws to an end will it be unblinded(if it was blinded at all)?
I'm sure that logically the results must get a good hard look before proceeding to phase 3.
Will the Australian equivalent of our FDA also be looking/aiding/approving
at that point?
The reason I ask is the phase 2 must last long enough to give a clear(ish) answer regarding the optimum dose.
Between that peek-in and the previous knowledge the Australian's have from the first trial(and ongoing extension), might there not be a compelling argument for approval.
I wonder if the trial is designed for the end of the phase 2 and a normally scheduled look-in to coincide or might we be getting a bonus look-in?
And finally, based on the previous phase 2 trial results, how long would the phase 2 need to last for clear dosage answer?
I think someone said the PD trial was not precision mediciney?
I agree. It would be a tough sell.
I think they'd be wise to wait.
It'll cost a hell of a lot more later on, but they'll still make a boatload of money.
The CEO that eventually hooks up with Anavex will be wealthy and able to write his/her own ticket for the rest of their life.
As the unofficial "10th man" I wonder if perhaps Dr. Missling et al. would prefer that the share price stay muted.
By our reckoning, a higher share price means less dilution, along with the warm, fuzzy feeling of a swelling account balance.
But maybe flying under the radar is our best case scenario whilst we advance our program.
Maybe Dr. Missling knows what we have is so big that whether its 50 or 100 million shares is of little consequence.
I've been pondering something along these lines this weekend.
I'm addicted to reading, so everyday I visit half a dozen or so sites that have links to a dozen or so articles each day( Business insider,Abnormal Returns,The Big Picture...) and pick a dozenish articles a day to read.
I believe going forward any medical articles I see I'll give special attention and contact the authors( info usually found at the bottom of the page) and point them at the Anavex story.
Might be a fools errand but I'd have to think they're always looking for content.
If I could have just one question answered it would be how closely is A-273 being followed by the Australian government (and how high up amongst their decision makers does this interest go)?
The one question I wouldn't want to know the answer to is the dollar amount Dr. M may have turned down(in regards to buyouts or partnerships).
The word infuriating comes to mind.
The world is desperately looking for help and they won't look at us.
One thing that bugs me a bit is Dr. M told our fellow board members at the ASM that he thought the share price would head up once the data was released.
I hope he wasn't counting on that to raise some cash.
The stock market is a highly irrational creature.
We have every right to expect a higher share price.
Netflix is bleeding billions( as is Tesla) but their stock price heads for the moon. Having a product with no profit is not a going concern at all.
In the late 90's just having .com in your name brought investors by the score.
Some companies were created with no stated purpose, and the money came.
On any given day there are plenty of biotechs with less to offer and no further along than Anavex trading at lofty valuations.
Anavex itself traded much higher with less to show a couple of years ago.
Anavex's share price is languishing but I expect it could turn on a dime.
One write up by a respected journalist or publication might very well do it.
Biogen announcing a deal and an upcoming Tysabri/A-273 combo trial would certainly do it.
We may stay at $3 for the next few years but it's hardly a foregone conclusion.
Wouldn't it be grand if 3-71 or 1-41 took care of the other 20%.
Thank you. I think I'll buy some more.
Just to make sure I'm understanding...
"In the study population, when participants with these variants (approximately 20 percent) were excluded, the remaining study participants (approximately 80 percent) showed improved scores on gold-standard tests of cognition (MMSE) and activities of daily living (ADCS-ADL) (p<0.05)."
Does this mean if we did this again with the same people but weeded out the ones we would now weed out, 100% of the the participants got better?
25 billion to their market cap, I think.
And here we sit and pout at 150 mil.
Thank you both.
Kind of what I thought but had nothing to base it on in my experience.
I'm still not quite getting it.
If you would, pretend you're the chief strategist at Biogen and I'm a top level exec.
Explain to me what we're doing/planning/hoping for.
I realize this is complete conjecture on your part.
Not sure what everyone here is inferring.
Dr. Missling said we have enough money for all 3 trials so I suppose stealing the show would keep our share price lower and would make us issue additional shares to access all available funds.
But how does this aid Biogen?
The trials will go forward and the results will speak for themselves.
I doubt Dr. Missling will throw his hands up in the air and say, "Ok, you win, you may partner/acquire at a lower price."
I would think we would be delighted to see one of our biggest competitors
head into a box canyon.
"Unburdened by knowledge, they pushed forward ." -Unknown
Do we have a bit of a clue in regard to this with the trial extension?
Whether for physical or mental reasons, it seems the phase 2 participants have no desire to do without.
Perhaps Biogen will highlight their upcoming phase 3 trial(to appease their shareholders) AND announce something (big or little) with Anavex, and with Pfizer backing off, declare themselves the king of the CNS world.
If they were going to throw some serious money at a relatively unknown company, a "package show" might be the way to go.
"it would be inhumane to maintain the placebo arm."
"The needs of the many outweigh the needs of the few.”