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They had two options. Traditional approval or AA.
The FDA already AA two other therapies, giving Anavex the map on what it’ll take to get there.
Heck, all Anavex has to do it show that they can hit that same mark, and it’ll be AA on mild side effects alone.
Let’s see how this post ages.
Don’t forget depression, insomnia, and seizures too
Come on now. How many top line results did he already mention met primary and secondary?
The goods is there, just be patient like a dubstep song and wait for the drop.
I’m interested in your thinking of the company having an anti takeover pill.
100,000,000 extra shares is a drop in the bucket compared to the potential sales of Blarcamesine per year.
If a slice of the pie is x amount, why not just be aggressive and take the whole pie if it’s THAT good.
Wasn’t Rett adult p3 trial already done and PR’d?
All primary and secondary endpoints met.
Just waiting on the pediatric P3 results?
Wasnt Biogen first approval based off of a p2 trial ONLY?
Same as their second approval?
Curious how exactly would he have upset said BP companies?
Giving them real statistics of a trial and they didn’t like the result?
He’s probably the most credible person working for Anavex right now.
I’m sure he’s having to also navigate the potential of being hostilely taken over.
There’s no poison pill poisonous enough, right now, if Anavex has the goods to be approved for all the above.
I bet we get the data and partner announcement on the same day
How about by summer of 24 Blarcamesine will be approved and pps will be over $80
Sure glad I can laugh at amateur conclusions.
Reminds me of that line from Tommy Boy
Exactly. Once revenue starts flowing…..Anavex will be taken A LOT more seriously.
I’d replace most with all to date. Even those currently approved, fail in the long run.
Funny how they all talk big, but when it’s trial result time, they slither away.
Remember NTRP days….. then on and on.
Yet here still stands AVXL
Gambling;
Seems like they moved from the slot machines were it was a LONG shot, to roulette, to now a game of hold ‘em.
So while it was a long shot a few years ago……Anavex is now on the final table.
Spot on. The fleecing of the Healthcare System
It’ll be interesting to see where Billy ends up after his stint with the FDA.
Why a breakthrough cure for memory care disorders likely isn't coming soon
Only Anavex's Anavex 2-73 drug is given a better than 50% chance of making it to market in that timespan
While SAVA has a 41% chance of making it to market in 2026, AVXL has a 52% to market by end of 2024
https://www.advisory.com/blog/2023/01/memory-care
News will happen when it happens.
We already know Parkinson’s p2 was a success, Rett adult p3 was a success, Alz p2b/3 was a success.
The co can’t possibly be lying about all three trials.
Yet, that’s what the FUD wants us to believe.
No matter what news gets released, it will be met with the same ol characters attacking.
Only thing that takes this to never seen territory is a FDA nod.
Time is becoming a factor for both longs and shorts.
Should of would of could of.
I actually DID add shares into a custodial account for the kids while the pps was in the 7’s.
Even sold (Roth) on Wed only to buy back on Friday gaining a few dimes per share to purchase a few more.
Am I a serious investor….nah….
Just retail not listening to the noise(fud) being made about the co.
Soon the climb to triple digits WILL begin.
BIIB wanted to see what they were up against.
Notice how quickly they pushed those ineffective therapies up for approval.
Nice to see State Street nearly doubling their holdings to the tune of a cool >7% of outstanding shares.
Obviously they along with BlackRock see something different than what the so called “knowledgeable” anonymous board posters, sky is falling type, here know.
Every year is the year for Anavex.
It’s another successful year of proving their foes wrong.
I’m sure a lot of people on this board disagrees with most anything that you say.
Don’t really have a winning track record
No. I didn’t mean that one. I meant Leqembi.
P3 wasn’t considered when the FDA AA the therapy.
Did you believe an AD therapy would be AA on P2 data ONLY a few months ago?
I’m sure the statistician is on that very case comparing the two.
Surely you can’t be serious……
Understand going after one trial result. All three? Just shows where you stand in the grand scheme of things.
Seems like the fud is turning it up a notch. Then again…..how much lower can the shorts risk taking it. Gladly been adding as the funds allowed. 250 for the 401k last week.
Everyone’s an expert on the type of statistic the company used these days.
Guess what, we have the premier statistician on board and good luck trying to twist anything THAT guy puts out.
And here I was thinking he meant it as “short change”
We won’t even talk about what it means in Ireland.
Then again, I am NOT offended by people calling a certain pizza a Hawaiian Pizza.
Curious to know your opinion on what you expect for Anavex over the next 12 months.
Eventually it seems like the MOA will prove correct as trials conclude and data analyzed. Each trial further cementing Anavex as the next BP.
Long strong and riding all shares to the end of the rainbow. Success or failure.
So, in summary, would you say that is why BIIB barely moved when their second drug got approved?
Investors assumed even though their drug got approved, it wasn’t a REAL win for the disease, just for the co.
Come on steady. You mean to say Amyloid clearing IS and when BP shows clearance it’s worth Billions…..?
Right now, EVERYTHING is a shot in the dark, even after 30 years of trials targeting one idea.
As of today, the new generation of therapies currently in trials are the most promising.
What BP is doing with their Amyloid submissions reeks of desperation.
Guess even they see the writing on the wall
I’ll say the same thing about the sava open label data that was said when Anavex ran the same type trial.
Meaningless
Missling said that the results released so far was ALL patients from BOTH active arms
Wouldn’t call it a failure. Just not nearly as impressive as the combined arm of Blarcamesine.
How about this:
Can the FDA keep the momentum going for rare disease drug approvals?
While trofinetide, which is being developed by Acadia Pharmaceuticals and Neuren Pharmaceuticals, has a PDUFA date in March, a regulatory decision for Anavex Life Sciences’ blarcamesine hydrochloride is also expected by the year’s end.
https://www.pharmaceutical-technology.com/features/can-the-fda-keep-the-momentum-going-for-rare-disease-drug-approvals/
As we all wait for the next move Anavex will make, it’s all the more encouraging that S1R is finally getting some attention from researchers.