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Your understanding of what is material information is at variance with what the SEC considers material.
I'm not understanding why managing the expectations of investors and shorts is a problem.
It may not be a game in your frame of reference. It is a competition between the various forces in the market as they jockey for profits, much of which come at the expense of other market participants.
Of course it is serious business, money is involved. That is always serious business. I suppose you object to the phrase "gaming the system" too.
When Missling made that statement he put the shorts on notice that there may be an unanticipated event in the future. That may have the effect of tempering the efforts of the shorts to manipulate the SP. That seems a worthy goal to me.
Damn. Price have come down. The economy really does suck.
Just three.
Ya got me. I shouldn't have used the word "just".
I get the revolving door thing. There is a question of what job would you expect someone leaving the FDA to take? Academics really doesn't pay that well.
After all, Anavex just hired three guys that are from the FDA and that was considered a very good thing to bring that expertise on board. Why are they considered good hires? Because they understand what the FDA wants to see and know how to present the trial data in a way that addresses the FDA's concerns.
As for wall street being corrupt, it is and always has been. The money game is mostly a no holds barred battle with the referee (the feds) being pretty slow to understand the game. Of course it is congress that give the SEC it authority or lack thereof.
Anavex is doing pretty well considering the weakness of biotechs in general and the shorting going on in its stock. Missling understands the game and has positioned Anavex very well.
Sorry but I can't follow your logic. Those are unrelated things.
FDA approved the mabs because there is nothing else to treat AD with except Aricept. They were under a lot of pressure to
give at least a glimmer of hope to AD families.
I gave a list of reasons in a recent post why Anavex sp is what it is and collusion between the FDA and BP is not on the list.
Until the 2-73 is proven in an approved NDA the MOA is considered suspect by the larger market. Really convincing data
from the Excellence trial might do it but I'd be willing to bet that AF will come in and muddy the waters even then.
My LVL II show 280 shares traded at $9.00 and a bit later 280 traded at $8.50.
Make of that what you will.
There is a sense of humor on the board. It is jest in short supply. 🙏
Buffett has the answer to that. “The stock market is a device for transferring money from the impatient to the patient.” Warren Buffett “Time is the friend of the wonderful business, the enemy of the mediocre.”
So what is the approved opinion that is not subject to intransigence?
The material part of your post is easier to answer. That is a responsibility of the company. The company's analysis of the data will tell the company if the trial was a failure which is a clear material event, if it is a clear success which is also a material event, or somewhere in between which is ambiguous and allows the company to sit on the results for a while while "it analyzes the results". As soon as the company has made a determination of those choices it becomes a material event. One can make the argument that even good results are not material since that is the expectation according to the SEC and it is the FDA decision on an NDA that is the material event. It is the NDA decision that has the financial impact on the company which is what makes it material. The expectation is success until there is a clear failure. The SEC is biased towards disclosing bad news.
The embargo due to a pending publication is a bit trickier. There are pretty clear guidelines for what a trial report is supposed to look like on Clinicaltrials.gov. The guidelines use the words "The process of submitting results information to ClinicalTrials.gov is conceptually similar to preparing a manuscript for publication in a journal."
Conceptually similar doesn't necessarily mean the same level of detail or analysis that a published paper might go into. I call that a grey area.
Historically the FDA has been very lax about companies not updating clinicaltrials.gov with final trial results. Recently the FDA has said that it is enforcing the requirement to do the trial results update. So as a practical matter being 6 months late in doing the update would not likely be noticed by the FDA so accommodating a publishing embargo might not be an issue.
Nice trading. I'm not willing to give up long term cap gains for a flip. Flip often enough and it would be well worth it.
Thank you proctor frrol.
Data in hand means all the data back from the CRO's and the lab results, genomic stuff etc. Then it gets analyzed and decisions are made on what and how to present it to the FDA for the meeting.
Given the recent info coming from the FDA they may have been waiting for the FDA to publish guidance on AA and what biomarkers it will accept before proceeding.
What you are referring to is Anavex making public the TLD for AD. I have no idea what Missling's thinking on that is.
What he tells us is far less important then what he presents to the FDA.
I don't think you appreciate the process for dealing with the FDA. Anavex can't request a meeting with the FDA over the AD trial until it has all the data in hand. Once a meeting is requested the FDA has a time frame to respond to the request and grant the meeting. Anavex then has to submit all the data that will be discussed in the meeting up to 50 days in advance of the meeting date.
Then the meeting can take place. At that point the FDA can make recommendations, suggestions etc. some at the meeting itself, others can take up to 75 days for a written response.
The same process applies to the Excellence trial.
Nothing moves fast with the FDA.
315 Table 1: FDA Meeting Request/WRO Request Response Timelines
Meeting Type
(any format)
Response Time
(calendar days from receipt of
meeting request/WRO request)
A 14 days
B 21 days
B (EOP) 14 days
C 21 days
316
317 Table 2: FDA Meeting Scheduling Time Frames
Meeting Type Meeting Scheduling
(calendar days from receipt of
meeting request)
A 30 days
B 60 days
B (EOP) 70 days
C 75 days
318
319 Table 3: FDA WRO Response Timelines
Meeting Type WRO Response Time
(calendar days from receipt of
WRO request)
A 30 days
B 60 days
B (EOP) 70 days
C 75 days
320
337 Table 4: Requester Meeting Package Timelines
Meeting
Type
FDA Receipt of Meeting Package (calendar days)
A, C* At the time of the meeting request
B No later than 30 days before the scheduled date of the meeting
or WRO response time
B (EOP) No later than 50 days before the scheduled date of the meeting
or WRO response time**
C No later than 47 days before the scheduled date of the meeting
or WRO response time***
C. Meeting Package Content
362
363 The meeting package should provide summary information relevant to the product and any
364 supplementary information needed to develop responses to issues raised by the requester or
365 review division. It is critical that the entire meeting package content support the intended
366 meeting objectives. The meeting package content will vary depending on the product,
367 indication, phase of product development, and issues to be discussed. FDA and ICH guidances
368 identify and address many issues related to product development and should be considered when
369 planning, developing, and providing information needed to support a meeting with the FDA. If a
370 product development plan deviates from current guidances, or from current practices, the
371 deviation should be recognized and explained. Known difficult design and evidence issues
372 should be raised for discussion (e.g., use of a surrogate endpoint, reliance on a single study, use
373 of a noninferiority design, adaptive designs). Also, merely describing a result as significant does
374 not provide the review division with enough information to give good advice or identify
375 important problems the requester may have missed.
376
377 To facilitate FDA review, the meeting package content should be organized according to the
378 proposed agenda. The meeting package should be a sequentially paginated document with a
379 table of contents, appropriate indices, appendices, and cross references. It should be tabbed or
380 bookmarked to enhance reviewers’ navigation across different sections within the package, both
381 in preparation for and during the meeting. Meeting packages generally should include the
382 following information, preferably in the order listed below:
The share price reflects Missling's decision to not use standard Wall street financing. If there were several large brokerage houses trying to sell shares there would be a lot of brokers busy pushing the stock.
We don't have that. Then there is the fact that Anavex is a completely novel MOA approach to CNS disease. It remains unproven in the eyes of many biotech investors and will remain so until an NDA is approved.
Add to that the failure rate for AD drugs, CNS drugs in general and you have a lower share price than what the current company progress might suggest.
This is a tipping point stock. Once the data, NDA, trial results pass the tipping point indicating that MOA is valid and the drug will be on the market, the share price will make up for its long depressed state.
I think Missling understands that which is why he mentioned wanting to surprise the market.
I look at AVXL as a coiled spring and when it is released it will rise with a lot of force.
Personally I don't think the short position is large enough to create a huge short squeeze. My thinking is the institutional buying will be much larger than the the shorts covering. That is not to say that the shorts covering won't be part of the pressure that increases the share price, but rather is will get swamped by the insty buying. Of course the shorts will feel some pain, hopefully a lot of pain but in the large scheme of things that won't be what drives the share price.
Still the presentation from May.
That is not just a dream, that is a pipe dream.
I suppose so is that dream of a shiny bicycle for Christmas with the sparkle paint.
Not enough volume to indicate "high pressure selling" or "bad news leaking".
All the biotech indexes I watch are down today. SAVA is up a small amount but it has been getting whipped of late.
Time for a new one. That is from May.
Sorry TT but I don't buy your story.
Rett is very likely to be approved. That will make Anavex a desirable place to park money if what you predict comes to pass.
Sometimes the murine (rat & mouse) models accurately predict the human response and sometimes they don't.
The problem is you don't know for sure until you do the testing i.e. trials.
You can have informed opinions. The FDA wants trial results.
New Ihub posting guidlines
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I'm hoping the answer to that is NO.
I get the ubiquity of the sigma-1 receptor.
I chose the phrase "highly suggestive" because at this stage of the process using the word "confirmatory" would be misplaced. The FDA wants to see trials in humans for a reason, otherwise they would approve drugs based on lab rat results alone.
Your willingness to crown 3-71 is belied by your investing philosophy. If it is that good and that certain, why only invest in the conservative manor that you have frequently espoused?
I prefer to see those subsequent clinical studies. Call me conservative if you like.
But subsequent clinical studies, in humans, will authenticate Anavex 3-71's ultimate superiority.
I'd like to think that the "likes" are more about the content of the posts rather than someone being a "follower".
Thanks for the compliment.
Falconer is extrapolating the results. That is a legitimate exercise.
I chose to write about the possible downside of the lab rat data, also a legitimate exercise.
He wasn't writing a full blown paper on the subject. He may well turn out to be right. Or partially right. I doubt that 3-71 will turn out to be a bust.
Your constant harping on him being a HS bio teacher as some sort of lack of credentials is misplaced. Many people choose to learn far past the degrees they have. It is what a person has learned that counts. I know enough people with advanced degrees that I wouldn't trust their judgement as far as I could throw them. I also know people that have no degree that have become very knowledgeable and expert in their field of interest via self education.
Lab rats are imperfect models of a human disease. They are not high fidelity analogs of humans.
The results you cite are very good in the rat model. I would call those results highly suggestive.
But to assume the translation from lab rat to humans is a risky assumption.
A P2 trial will test that assumption. If it proves to be that the lab rat results translate in to humans, 3-71 will be a huge success. Those results are certainly strong enough to move forward with trials as Anavex has done with the P1 trial. Now on to a P2 to get an idea of what 3-71 will do in humans.
It's called a knee jerk reaction. Doesn't require any thought.
Interesting thought.
If I was a BP looking at partnering with Anavex on 2-73, looking at 3-71 would make me pretty nervous.
3-71 could replace 2-73 in the marketplace in 3 to 5 years. That could be a factor in Anavex not having pursued 3-71 very aggressively till AD is approved and a partnership deal made. Anavex needs that income stream from 2-73 to defray the development costs and to fund the development of 3-71.
Looks to me like there is steady buying pressure. Not very strong but steady. It is easily overwhelmed by the shorts and when the shorting pressure stops the buying pressure starts moving the SP up again.
That's my theory de jour and I'm sticking to it.
This could be the start of the epic battle for AVXL. If that is the case we should see the volatility increase over the next several months.
We shall see. I have my tickets for the show and it could be an E ticket ride.
Did you do it?
Isn't Tasha a one and done treatment?
Do you think the folks that have 16,000,000 shares short read Ihub?
It seems to be going up without the pump at the moment.
Up 45%.
Boredom is a terrible thing to waste.
They sold a shrimp? 😱
I guess it's Emily Latella time.🔁
I edited my post to make my point a bit clearer.
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