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The EMA will never rule on our (non-existent) NDA. That’s because the filing in Europe is a MAA (Marketing Authorization Application). A NDA (New Drug Application) is what sponsors file with the FDA.
Facts matter.
You’re wrong, at least based on history. Every time something similar is said, the WGTers find an excuse to let Missling off the hook. They’ll blame just about anybody or anything in order to avoid holding Missling accountable. To hold him to account would be to admit being wrong, which is intolerable for those who have invested so much in being right.
Here’s one possible excuse: What does the end of the year matter as long as it eventually gets filed? These things take time. After all, it’s biotech.
No, there will always be excuses made for missing timelines and Missling will always be given the benefit of the doubt. That, at least, is one thing we (and Missling) can count on.
Problem is Missling has never delivered anything on timelines that he himself has set. No reason to think he’ll start now and every reason to think he won’t.
Keep trying to draw in the gullible suckers. There’s bound to be at least one still out there somewhere.
Anavex is where people in the final stages of their careers go to die.
In theory, it’s possible they’ll file in 4Q. However, Missling’s track record is poor. It does not inspire confidence. Promises made, promises missed. Over and over. This has been Missling’s MO.
Missling to the rescue!
Such nonsense.
“Where is my news?”
More to the point: Did you or anybody fall for his nonsense and buy stock only to see it down today? I sure hope not!
“Yet another in a long list of huge fails of posts by George that didn't end well.”
And yet he persists. The question is, Why?
I remember years ago when a lot of posters thought Australian regulators would be the easier path to approval of Blarcamesine. How did that work out? Fast forward to today and its European regulators who some believe will be easier on Anavex. Hence the opinion that “many companies are choosing to go for a Europe, the UK, etc. first.” Of course, no actual evidence of that has been offered.
IMO, the idea that Europe, the UK, etc. offer an easier path to approval versus the FDA is simply another excuse to let Missling off the hook.
As for all the negative views of the FDA, I guess these folks would be perfectly happy going back to the days of hucksters selling home-made concoctions off the back of horse-drawn wagons to frightened, desperate people. Me, I’m fine with the FDA for the most part. Is the agency perfect? No. Could it be more streamlined? Possibly, just like any other institution could be.
“Unlike EF Hutton, when Missling talks, no-one listens.”
Ironically, EF Hutton covers Anavex, so it looks like nobody is listening to EF Hutton.
What exactly is the point of your post, which you have posted dozens of times? Why do you automatically ask it of DOC328?
Yes, because some people have a problem with dishonest people who are trying to fool suckers into buying stock now based on nonsensical predictions that lack any detail or context so that the dishonest people can try to sell into a rising market. It’s called pumping.
Wrong! You really need to read the Pumper’s Handbook. It goes like this: Keep posting predictions of imminent HUGE NEWS and encourage investors to buy shares ahead of the news to get suckers to buy. Draw in the suckers to give the stock a bump up. Then sell shares into a rising market. When the stock eventually falls, reload. Then do it all over again.
There is no mystery here.
Exactly right. There is no equivalency.
It’s fewer, not less. And apparently BMS doesn’t agree with you.
“Anavex 3-71 is the most potent with the fewer side effects.“
BMS is a smart company. They were acutely aware of all the clinical stage drug candidates targeting schizophrenia and other CNS diseases. If they thought 3-71 had superior safety and efficacy versus KarTX, they’d have bought Anavex instead of Karuna and they’d have done it for a whole lot less.
Hopefully nobody is being fooled into parting with their money on your say so.
Exactly the point I’ve been trying to make. BMS is a juggernaut that will dominate the market. Meanwhile, Missling is always behind the curve (except when it comes to feathering his bank account).
Missling/Anavex has never met a timeline that he himself has set. There’s no reason to believe that will change. As noted in this article from CNBC, BMS is already pursuing 6 other indications with KarTX, including Alzheimer’s patients with psychosis. https://www.cnbc.com/2024/09/26/fda-approves-bristol-myers-squibbs-schizophrenia-drug.html
Missling/Anavex is in no position to compete with this juggernaut.
In all his years as CEO, Missling has never met a published timeline that he himself has set. Why would he start meeting them now? That at least is what the smart money apparently thinks.
Keep dreaming, ‘cause that’s all you got.
You’re arguing over semantics? This all boils down to one very simple fact: Missling/Anavex is a weak competitor. He lost the PDD opportunity. He lost the Rett opportunity. He has now lost the schizophrenia opportunity, and he’s probably going to lost the AD opportunity to bigger, better resourced competitors. Missling makes the tortoise look like a speed demon.
I wasn’t talking about other companies. I was talking about Missling/Anavex. Missling/Anavex is a weak competitor with a buffoon of a CEO who makes millions every year while shareholders suffer. As you yourself have pointed out thousands of times, AVXL is a schitty stock.
It’s a schitty stock for a good reasons, and that has nothing to do with a so-called cabal.
Missling has already lost the PDD market and the Rett market. AD will be next. Much better resourced companies are pouring money and research into AD.
Keep dreaming of riches to be made in company with a CEO who can’t shoot straight.
Missling/Anavex (same thing) has blown an opportunity to address the $8 billion schizophrenia market. He slow-walked development as usual, which allowed a more nimble competitor to beat him to the goal line. There is no way Anavex will ever be able to compete against BMS. It’s over. Might as well ditch the program, just like he did with PDD and Rett.
The people at BMS are smart. They know the space. If they thought Anavex had a superior molecule in 3-71, they’d have bought Anavex instead of Karuna. Now that they own Karuna, I’m certain they will be pursuing other CNS opportunities that Missling/Anavex has on the pipeline chart. Again, Anavex simply cannot compete.
Yes. And insurers will gladly cover it. Also, as is typical, most patients will not be out of pocket. It’ll be cost effective and most welcomed by the community.
Exactly right. Recruiting schizophrenic patients will be next to impossible now that KarTX is approved. Missling’s operating at a snail’s pace on a shoestring means another big market opportunity (Rett syndrome was the most recent) has been lost to a nimble, competent competitor with much deeper pockets and global marketing clout.
There is no way the approval of KarTX is good news for Anavex.
The people at BMS are very smart. If they thought 3-71 was a superior molecule, they’d have bought Anavex instead of Karuna.
I do admire your unrelenting efforts to make negatives into positives. On the other hand, it’s disgusting.
I’ll say it again. Missling has once again lost a big market opportunity to a more nimble, more competent, and deep pocketed competitor by virtue of his cheapness and dilly dallying. The only people hurt by his stunning incompetence are the shareholders.
Whatever you’re smoking, I want some.
This HUGE NEWS is great for shareholders of Bristol Myers Squibb, which has just received FDA approval for their KarXT for schizophrenia. Once again, our illustrious CEO, Christopher U. Missling, PhD, MS, MBA, BSr, is way behind the curve in terms of development of 3-71 for schizophrenia and has lost yet another big market opportunity (schizophrenia estimated at $8.2 billion annually) to a faster, more nimble competitor with much deeper pockets.
This is absolutely not good news for Anavex or its suffering shareholders. To pretend that it is good news for Anavex is beyond ridiculous (or perhaps simply delusional).
Yup. AVXL just bobbing up and down with no conviction on light volume like it has for months. There is no investor expectation for GREAT, ABSOLUTELY GREAT, or even HUGE NEWS anytime soon.
Where was our HUGE NEWS today, George?
You may apologize now.
Credibility (whatever little there was of it) has been shattered.
Not just no news, no HUGE NEWS!!!
When there’s no HUGE NEWS tomorrow Georgejjl will try to deflect our attention from his latest failed prediction by predicting HUGE NEWS next week.
Last week Georgejjl emphatically told us to expect HUGE NEWS this Thursday, September 26, 2024.
Stand by.
I don’t know what “normal” volume means on your planet but the average daily volume in AVXL is 986,660. Today’s volume was 418,847. That’s 56.53% lower than the average daily volume. Safe to say today’s volume was not higher than normal. In fact, the volume was pretty light. With the stock bobbing up and down aimlessly on low volume, there is clearly no investor expectation of HUGE NEWS on Thursday.
And by the way, predicting that the stock will close higher on an up day with 45 minutes to the close isn’t exactly remarkable.
AVXL up a whopping 10 cents on anticipation of HUGE NEWS on Thursday, September 26, 2024.
Medical quackery targeting frightened people. Sound familiar?
George has promised HUGE NEWS on Thursday.
Just have to be patient.🤷♂️
To save you and others like you from yourselves, of course.
By the way, I just made a large donation to the Michael J. Fox Foundation with the stipulation that none of the funds be allocated to Anavex.
Apparently Georgejjl thinks his antics have an effect on the stock price. Why else would he post his silly predictions so relentlessly? The only other possible explanation is that he is deeply disturbed.