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There is a setting on the my ignores page that allows you to not see replies to ignored posts.
I suppose that is a possibility. They seem to be enough different that I wouldn't expect to see the PDD data in an AD paper. Perhaps as supporting safety data.
I think he said the PDD data would be submitted for peer review. That doesn't mean that it will be accepted.
You can always get something published in a pay to publish journal but that has minimal impact. Missling would probably want a more legitimate journal or none at all.
Looks like for PDD it is none at all.
Last time I checked conspirators do their best not to leave a trail of evidence.
Which is not to say that every conspiracy theory is correct also not all of them are wrong.
One of my favorites is the agreement between incandescent light bulb manufacturers to produce bulbs with a limited life span. The group fined companies that produced bulbs that lasted too long.
Is that a conspiracy? Just market manipulation? Just a cartel?
Short report is out. As of clearing date of 3-15 the short position is 19,998,803 down about 20K shares.
Shorts don't seem worried about news.
Could one of you industry guys help me understand what sort of techniques the shorts have to protect themselves from Anavex getting really good news and the attendant SP rise?
How about responding to the points I made rather than a personal attack with the usual tropes? Can you do that?
If that is true you are a lying, manipulative POS. Oh wait. That is true whether you had 11 million shares or not.
Good point.
Looks like that was the plan.
Several posters have commented that the AD results were not strong enough and that is why Missling wants to wait for the OLE data.
That may be the case. I prefer to think that getting the OLE data strengthens an already strong case and waiting for that to be available fits in with the timeline for the FDA Rett guidance.
According to clinicaltrials.gov 7-31-24.
If that is what you were thinking I would have expected that next sentence to have been highlighted also.
One would hope that if there is a hostile buyout attempt that it would trigger a bidding war.
What is you opinion of the strength of Anavex's takeover protections? Do you think they are strong enough to make a company considering such a hostile takeover think twice?
The basic situation has not changed significantly.
Anavex is pursuing a completely novel approach to treating AD and other CNS diseases. It is an as yet unproven approach to CNS diseases that is at odds with conventional wisdom.
What has changed is the various trials have strengthened the evidence that Anavex has a valid approach. That is still not an approval for the drug.
Many of the "big boys" will be happy to wait until there is an approval which will validate the Anavex novel approach. Yes they will pay more for shares and they will also incur much less risk. Even with paying more there will still be a lot of money to be made in buying Anavex.
On top of that, the share price has not maintained the $5 SP that is a lower limit for many institutions to buy and hold shares. Why the share price has been so low is a question for each investor to answer for themselves.
It comes down to risk reward balance. The big investors value capital preservation highly and take risks appropriately. Many retail investors are willing to take larger risks in pursuit of larger gains.
I have much of much allocation of high risk money in Anavex. The bulk of my money is in much more conservative investments with a strong bias towards capital preservation.
WilliamM. Thanks for that update.
There is always some merit to looking at things from the worst possible viewpoint. As they say...hope for the best and plan for the worst.
Missling has never discussed meetings with the FDA and on those few occasions where the results of FDA meetings have been mentioned it was because of some controversy. The point being that drawing conclusions about Anavex and FDA meetings because there have not been any PRs is probably wrong.
The plan was Rett first and AD second. The plan for Rett is undetermined till the FDA provides guidance. I suspect that until the Rett path becomes clear the timing of filing an AD NDA is also up in the air.
For example, if the FDA decides to let an NDA for Rett go forward, it would be decided before an NDA for AD because of the fast track designation. That would, if approved, obtain the voucher worth approximately $100,000,000. No small sum.
If the FDA decides Rett needs an additional trial then the time to do such a trial would be so long that delaying the AD filing till afterwards would not make any sense. In that case I expect to see Anavex file an NDA for AD fairly quickly. Quickly being after the current OLE is completed which should be in a few months.
The actual MAA submission to the EMA will be after the OLE is completed so getting that process started makes sense.
As you can tell I disagree with your assessment for the above reasons. We shall see what actually happens as it unfolds.
I suggest you listen to Sandra Boenisch in the CC state the 4 year cash runway. https://video.wixstatic.com/video/79bcf7_c8598d84565648258861db371a2527c6/720p/mp4/file.mp4
The point wasn't whether selling shares at $4.50 was a great way to raise money, it was that money can be raised as required. Obviously selling shares at $20 would be a better deal.
That's just like, your opinion Man. "I'll stick with my opinion that AVXL is in a shaky position." I'll stick with my opinion that Anavex is making progress. It is the end result that counts, not the bumps in the road as it gets there.
Yes I do expect additional trials to commence. Probably not until the FDA has provided guidance on Rett so the company knows what the path forward looks like and can allocate resources in an informed way.
And there was the sentence just after the one you highlighted.
First that $121 million is supposed to be enough to last 4 years assuming no additional income.
Second Anavex has been able to sell shares via the ATM and there is no reason to think that won't continue as a way to raise money as needed.
Third schizophrenia has been on the development chart for a long time.
Forth Anavex is not in a shaky position.
Rett was a set back. How much of a setback has yet to be determined. That depends on the FDA.
If the FDA requires an additional Rett trial it is likely that we will hear about an NDA for AD being prepared in short order.
Then there is FTD and PD trials to get started.
Your post assumes that the FDA won't approve an NDA for AD. Why is that?
The only way there would be a $32 buyout is if there are very good things happening. If there are very good things happening then $32 would be at a serious discount.
Short report is out tomorrow after the close.
I have to run to the bathroom after seeing that.
That theory has been shown to be wrong over and over again yet you still post it. Why?
True the majority of insty shares are help by index funds but there is a chunk that are held in optional funds.
Probably not going to be a year for important news.
We should get the Rett pathway and the peer reviewed paper.
Schizophrenia trial should be well underway.
AD NDA filing is likely.
Additional trials started.
I'll vote for that. 😉
As I understand it ADCOM is a decision made by the FDA not a requestable item.
Dufus. It's calendar days. I made that mistake and was roundly corrected by this board with quotes of the regs. Pay attention.
And the difference is what?
It will take as long as it takes. There is no set schedule. As we have seen from the Mabs, there can be some gut wrenching ups and downs in the trial and approval process.
Warren Buffet famously said that “the stock market is a device for transferring money from the impatient to the patient.” Real investing (as opposed to speculating or gambling) takes time above all else, so it pays to be patient.
Jim Rogers. "Most successful investors, in fact, do nothing most of the time."
I'm not fully convinced of anything. If that is your metric I suggest buying gold.
As far as MAA and NDA filings, I do give those very high probability.
I also think there will be an NDA for Rett. The question is whether an additional trial will be required or not.
The tape is not that good of a long term metric when observed in the short term.
If you think that Anavex has the science then patience is required. If you don't think Anavex has the science then it is day trading and the tape is everything.
Is this moving slower than I would like? Of course. Would I like more information to make me feel more in control? Sure. Will that change the ultimate outcome? Probably not.
The only real issue with Missling is his chosen communication approach. You and a number of others don't like it and are calling for his head.
As far as the n for the pediatric Rett trial, that was chosen by the trial designer based on previous strong results. I doubt that Missling designed the trial himself. Yeah, I get he approved the design so if you want to hold him accountable that's fine, but that is not his expertise. Anavex has staff that do that.
AD MAA process has started. US NDA is waiting on the OLE data before submission. A new CEO won't change that.
Rett is waiting on the FDA and possibly the OLE data. A new CEO won't change that.
Peer review paper is whatever it is. A new CEO won't change that.
Financial position for the company is great. A new CEO won't change that.
So a new CEO would basically change the communication approach and little else. Perhaps start more trials with the attendant reduction in the overall financial position.
It has become a less civilized forum. While it is not a cess pool it it has increased its odor strength considerably since the rule change.
What the hell Paulie? No mayo?
From the PR.
If Missling used the word complete in one of the CC calls, I missed it.
Anavex had no choice in going with the Centralized Marketing Procedure. It is compulsory for drugs that treat neurodegenerative diseases.
That is not to minimize the importance of obtaining the go ahead.
In your short dreams.
This has always been about getting approvals.
The rest is entertainment.
I'm guessing the concept of integrity is a bit difficult for you to imagine in others.
You must be pretty hard up for entertainment to be hanging on a board to watch "morons". To each his/her/their own.