Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Overall market is red today. But why pass up on an opportunity to dis someone?
XBI -2.33%
AVXL -2.33%
SAVA -10.95%
NWBO -3.46%
NVDA -2.75%
UK and the EMA have very different timelines.
The EMA has a 7 month delay from the time a letter of intent to file is approved till the actual MAA can be filed with the EMA/CHMP.
From reading the NWBO board it seems that the UK doesn't have anything like that delay in the process.
Not really a good analogy. Nicholson got a lobotomy. I hope to do better with Anavex. 😉
How do you know this?
I seriously doubt that the FDA cares about which agency approves a drug first.
Just like the EMA didn't seem to be impressed with Aduhelm, the FDA will deal with what is submitted to it when it has the file in front of it to review. If another agency has approved a drug I would suspect that the FDA would see that as a positive. Would that be enough to cause the FDA to approve a drug without a full review of the submittal? I doubt it.
After all, The FDA can't approve a drug that hasn't submitted an NDA.
Your command of the obvious is legendary.
That was the last paragraph in my post.
Thank you for making my point.
I understand it quite well. I also understand random selection and the issues involved. Both type 1 and type 2 errors to occur.
You may want to delve into that just a bit deeper to understand what the reality is.
Most of the PI funding to the FDA comes in the form of NDA application fees. The FDA gets that money from the company applying for an NDA up front. Since the FDA is the only game in town the approval rate has little to do with the amount of money the FDA gets.
If a company wants access to the US market they have to pay the application fee to the FDA. The implication that there is a quid pro quo involved doesn't stand up to scrutiny. The fee schedule is published. All PI companies pay the same fees.
You can argue about the approval of the Aduhelm drug against the advisory committee advice and that would be a legit argument. That also lead to investigations etc.
Sure there is a chance that a change in CEO might bring a long term improvement, just as there is a chance a new CEO could make things worse.
Consider that if the Rett trial had not had such a strong response in the placebo group there would be an NDA filed by now and Missling would be a hero.
Also consider that if the trial had been larger it would not necessarily have come out differently and Anavex would still be in the same place.
There are legitimate criticisms of Missling's communication strategy and the way Anavex handled the trial endpoint communications. At the same time Missling has positioned the company very well in my estimation. Most of the recent clamor for Missling to be replaced is a result of a single trial outcome that was unexpected. My point is that demanding Missling's job based on the unlikely result of trial seems more like an expression of frustration than a serious evaluation of his overall performance.
I make no apology for Missling nor do I claim he is the golden child. He is a CEO managing a developmental stage biotech through a difficult developmental process, attempting to get a drug or drugs approved and on the market. That process has ups and downs as can be seen by looking at other developmental drug companies. The failure rate of bio tech developmental companies is quite high and it appears to me that Anavex is negotiating that process pretty well with a very good chance of success.
Well. There is the obvious.
22,000,000 shares of a short position has a value of about $94 million. Now the shorts didn't sell those shares at $4.30 but a lot higher at $5 to $9.
So do the math an figure out how much cash the shorts have in their accounts. The short net position is the difference between the price they sold and the current price, but that is not the amount of cash in their accounts for the short sales.
The longs have their shares at a share price of $3 to $10 depending on when they bought. So at this point they may be down -$1 to -$6 depending on their average cost basis.
The difference is the longs have ownership in a company that hopefully will have value in the future. The shorts have a bet that Anavex will fail.
The upside for the longs is much more than the upside for the shorts.
The longs don't need much if any money to continue their position in the future. The shorts are paying borrowing costs every month. They are increasing the size of the short bet. The short position increased 10% over the last reporting period. 2 million shares x $5 = $10,000,000 that went in to the short accounts. Pretty good work for a two week period.
Pretty much like the contents of your posts.
Oh wait... Anavex has something of value in development. You, not so much.
You keep thumping that drum without considering the consequences. At this point with the SP being down and the bashers piling on, changing senior management would be playing into the shorts hands.
Let's consider what might happen if Missling was replaced . What would change in the corporate strategy in the near term? Do you have an answer for that?
Even if there was a change in CEO tomorrow what what change?
Maybe a bit more communication? Perhaps. Any change in the the trials underway? Any change in the up coming trials?
What overall change in corporate strategy do you see?
Any change in in CEO is not going to have a short term improvement.
The shorts have a massive amount of money to work with. They can ride out a pretty big hit to the SP and then start shorting the SP back down.
For Missling to have any real chance of hitting the shorts in a sustained way he has to have sufficient news/progress to start and hold an upward trend over not just a week or two but a longer period.
To me that means more than just a PR about filing 1 or more NDAs and a good peer review paper. It means an approved NDA and a partnership with a major chunk of up front cash.
My 2¢ worth.
The general opinion on the board is that it has little to no merit.
Many consider it to be a short tactic. The latest short report showed close to a 2,000,000 share increase in the short position to 22,000,000 shares short.
There are other's that feel that Anavex brought the suit on by the poor communications habits.
You will have to make up your own mind.
Ummm. The company hasn't said what the unnamed rare disease is and it hasn't said that trials for it have started.
You need something else to bitch about.
Here is a paragraph from the Anavex PR on the 3-71 P1 study.
The Phase 1 showed that the dose could be quite large.
The multiple ascending dosage up to a target will show what the effective dosage is.
At this point the ideal dosage is unknown no matter what the expectation is.
There is a lot of PK data being taken in the part A that will determine what the appropriate dosage is.
The trial has 3 arms. The two dosing arms do have ascending doses with each arm dosing up to a target dose. That means to me that they are ramping up the the dosage to the target dosage.
You are correct in the part B dose being determined by the part A dosage results. It would appear that the dose will be either 30mg or 60mg.
My, my, my. It's nice to know we have prosecutor, judge and jury on the board.
You better hope that no one takes too close a look at the crap you post.
That explains some of the share price drop.
That is the single biggest increase in the short position in the last year. 2,119,132 share increase.
Thanks for posting that.
Alright. I'll play your silly game. Show me what is wrong with those two posted quotes.
I'll go with what the folks that sponsored the event called it.
Your opinion of what it "really" was is OK with me. Frankly Scarlet...
Gosh, I don't recall using the word irredeemably. And yes, I was posting about the vested interests of some reviewers.
I assume you are familiar with Ignaz Semmelweis.
As far as this comment "Steady, you need to get real. Read what you write." In the immortal words of Elon Musk...GFY.
So the concept of vested interest does not exist for you?
Upton Sinclair said
Hard to say. They don't send out program notes with their agenda on it.
You do realize that was a Healthcare conference, right?
People will want to know about the drug and how it works as well as the market for it.
Not only that, but it is likely that the people doing the peer review have a strong vested interest in delaying the Anavex paper as long as possible since their research and funding may be impacted by a paradigm shift.
As I understand it, it only takes one of the reviewers to slow down the process.
Rather, as German physicist Max Planck somewhat cynically declared, science advances one funeral at a time. Planck noted “a new scientific truth does not triumph by convincing its opponents and making them see the light, but rather because its opponents die, and a new generation grows up that is familiar with it.”
Some of the 2023 SEC enforcement actions. Cabal, maybe, maybe not. Bad actors certainly.
The SEC charged broker-dealer Citadel Securities LLC with violating a provision of Regulation SHO that requires broker-dealers to mark sale orders as long, short, or short exempt. Regulators routinely use these records to police prohibited short selling activity. According to the SEC’s order, Citadel Securities incorrectly marked an estimated millions of orders for a five-year period, inaccurately denoting certain short sales as long sales and vice versa, and provided the inaccurate data to regulators, including the SEC. Citadel paid a $7 million civil penalty to resolve the charges and consented to a set of undertakings, including a written certification that the coding error had been remediated and a review of the firm’s computer programming and coding logic involved in processing relevant transactions
Market Abuse
In fiscal year 2023, the SEC brought enforcement cases addressing a variety of abusive trading practices, such as insider trading, front-running, and market manipulation. For example, the Commission charged:
Eight social media influencers for allegedly using social media to manipulate exchange-traded stocks in a $100 million securities fraud scheme;
Two financial services industry professionals for allegedly perpetrating a multi-year front-running scheme that generated at least $47 million in illegal trading profits
n the Division’s recommendations, the Commission filed settled charges imposing robust financial remedies against major companies in actions that addressed a wide range of securities law violations.
For example:
Twenty-five advisory firms, broker-dealers, and/or credit rating agencies, including Wells Fargo, HSBC, and Scotia Capital, agreed to pay combined civil penalties totaling more than $400 million to settle charges that they violated the recordkeeping requirements of the federal securities laws;
Now if you just learn how to spell it.
Fault for the lawsuit is not the issue. The strength of the lawsuit is. And so far it looks to be a nuance rather than a serious threat.
20,000,000 shares short is not a conspiracy. The short value of $100,000,000 is not a conspiracy.
If you think that there are not efforts being made to protect that amount of money then I suggest you are being willfully blind.
According to the FDA there is only one surrogate biomarker for AD and that is plaque reduction. There are no qualified biomarkers for AD according to the most recent list I could find on the FDA web site.
The FDA has indicated that it is willing to consider other biomarkers in NDA submissions.
If I have this right, plaque reduction wasn't considered a valid surrogate biomarker until the mab NDAs were submitted.
There are a number of biomarkers that are used in diagnosing AD. What the FDA has to say about that won't be known until they are put through the qualification process or used in an NDA submission.
You are right. It is a remote possibility.
It is my understanding that in general MM's don't carry large inventories of shares. Some of the investment/brokerage houses may build an inventory but that is generally not on the MM side of the house.
I'll pose that as a question to the folks on the board that have industry experience.
So if the shares went from shareholders to shareholders... I'm confused.
So what happened on the day when there was 117 million share volume?