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Correct. Dr. M stated during the shareholders mtg that Sigma-1 acts as a cell chaperone throughout the body. They have seen laboratory results that indicate heart health may be improved.
If it walks like a duck and acts like a duck...
Time will tell... hope you're holding shares.
It amazes me how the world's next miracle drug still remains the best kept secrete!
No matter how much it's beaten the horse won't get any deader!
Here's a thought...
If the data is available, but is not anymore significant than the recent ODD PRs, wouldn't you think that it would have been released by now? The fact that it's taking this long tells me that the data is very significant, is being shared and that likely a bigger announcement is in the works.
Breakthrough Drug (or Designation)
I thought it a bit peculiar that P3 was not being scheduled earlier than first of next year. It would seem that Anavex, as well as the FDA, would want to move more rapidly if it's deemed P3 is necessary.
Perhaps it's because Anavex needs time to arrange the needed partnership for funding...or it is purposely delayed to allow the FDA time to analyze and determine if BTD is warranted, not having to spend any money in the preparation of P3? Certainly more questions than answers.
Soon, grasshopper, soon...
Have a great trip! AVXL might be $15 when you return. :)
Yes, and in that .1% are the nefarious cabal that's keeping a lid on the PPS. Once 10% or more of the investing public are made aware then the top blows off of this pressure cooker.
I find it absolutely amazing that we, on this board, share this knowledge of an impending breakthrough "curative" treatment that 99.9% of the world has no clue is coming.
The MF article (bull vs. bear) seems to be a CYA "bridge" piece that starts to move them from a totally (fabricated) bearish position to finally suggesting there could be value with AVXL. This way, when the great news comes out, they can fully move to a bullish position, without looking completely foolish.
dmb, you do realize that AF, JF, MD and the like are all part of and hired by the nefarious cabal that manipulate microcap stock prices? I'm sure they don't even believe what they write; they're just paid to write it so that the MMs and hedgies can point to something to "justify" their actions.
Unfortunately, it's necessary to take the time to call them out on their negative and slanderous posts, in order to make naïve investors aware of the game. Thank you for taking the time to do so and to report them to authorities.
For those who cannot understand why the PK/PD results are taking so long, here's a primer on the subject; it's quite extensive...
Introduction to Pharmacokinetics
and Pharmacodynamics
http://www.ashp.org/doclibrary/bookstore/p2418-chapter1.aspx
By the time there is significant off-label usage, we'll likely be 6 months into P3, which is when I believe the FDA will grant approval anyway.
Generally speaking, that's correct. But once the partnership is announced (provide a recognizable one) and with good 12-wk PK/PD data, news will begin spreading within the industry and on Wall Street. That should sufficiently get the news flowing quickly.
Many believe that manipulation is one sided (down), but the truth is it's both. The positive reactions to small PRs, such as today's, and the AU media spots are primarily the MMs and hedgies exaggerating the direction of the movement. Then when the upward move fades, they begin to bring it right back down. They thrive on volatility.
This stock will not see sustained lift until there is a partnership and widespread national news, which should happen in the coming months. For this company and its positive developments, patience is a virtue.
Their sole purpose is to disparage the company.
Seems to me they could present the MMSE, cognitive and daily-living results without the PK/PD, if that's all that's holding it up. PK/PD don't necessarily apply to efficacy.
ip_man, I'm totally in sync with your line of thinking.
Nice analogy... and often times the price of admission is less when you buy early. :)
Does the below not apply? Isn't it broad enough to encompass AD?
2-73: U.S. Pat. No. 9,180,106 granted on 10/21/2015
SIGMA RECEPTORS LIGANDS WITH ANTI-APOPTOTIC AND/OR PRO-APOPTOTIC PROPERTIES, OVER CELLULAR MECHANISMS, EXHIBITING PROTOTYPICAL CYTOPROTECTIVE AND ALSO ANTI-CANCER ACTIVITY.
Indeed, the placebo effect in some people is amazingly strong; however, I wonder what that type of study would show for Alz patients.
Wouldn't they have to PR the news before they can present it to a select group?
When the PPS is north of $15 later this year, it will look great!
4.03 is a VERY good price!
I see. Welcome to America! Go Anavex!
I don't believe that question was raised, as they cut us off after about 30 min of Q&A. I wished that the question had been asked; it would have been interesting to hear the response, if any. But if Missling is true to his word (which we believe he is) then a partnership is very likely. The involvement of Clayton Parker speaks volumes.
Yes, Parker addressed the attendees about the negative and slanderous articles, saying that the SEC is aware of them. Anavex will not respond to the attacks, because it will only open the door for additional attacks. The company won't even take calls from SA, MF and the like because they will twist anything Dr. Missling might say.
Missling and Parker both reiterated that Anavex had no role in the Australian media releases. They were surprised to see them and would not comment. It was all motivated and initiated by the media based on trial leaks.
You're welcome, Dark. My overall impression of the shareholders' mtg was quite positive and, yes, I did get to meet and talk with Dr. Missling and the attorney (Clayton Parker) prior to and during the mtg. They were equally impressed with the number of shareholders in attendance, which were mostly from the FB group (12), and the enthusiasm we conveyed through our questions (which mostly were unanswerable).
Certainly, we were a bit disappointed in not gaining any additional tidbits of information (understandably), but still we had a very positive experience and interaction with both Missling and Parker, who explained things very well. It was quite interesting to hear Clayton talk a bit about the negative articles, which are full of mistruths/lies and what's behind it, as well as his conversations with the SEC. About the subpoena he would not comment, only to say they are working through it.
Post meeting, the "dirty dozen" had lunch together and shared our thoughts, questions and (positive) impressions. BTW, Lilac is a "she"...her name is Sharon. I don't know about the autograph; hope she got it.
You're welcome... my pleasure. Know one really knows when the 12-wk PK/PD data will be released or if it's available. However, "IF" they are purposely holding it up, the only reason I can think of is because of partner discussions; otherwise, why wait?
I like the logic; I hope you're right.
Some at the meeting felt Dr. M's comments about presenting data at next week's conference as being doubtful. But I didn't necessarily have that same feeling, as I couldn't connect exactly what he was saying...he was very vague.
In any event, unless a conference has a "data embargo" requirement, it would seem the company would have to PR the news prior to any presentation, for the same reason they couldn't provide any new information to the attending shareholders last week.
At the meeting, when Dr. Missling commented about Anavex Plus not showing to be anymore beneficial than 2-73 alone, he seemed to indicate this was good news in that only one drug would need to be administered (i.e. less is better). Plus, donepezil is not well tolerated by 20% of patients, thus, avoiding the adverse side affects many exhibit with it. Therefore, I'd be surprised that they continue with the Plus patent, unless they just want to have it in their back pocket.
That's the guy. I was very impressed with him during the shareholders' mtg. I found it intriguing him mentioning that the regulators (i.e. SEC) contact him periodically. They are very well aware of what's happening to the stock and by whom.
Doubtful this will affect the price much. Now, if it were another hit piece filled with misinformation, you could bet your bottom dollar the price would tank.
Obviously, you like to live dangerously flipping for pennies. The only problem with that strategy is if you are caught short when they announce the data, then WHAM! You have to cover at 3x the price. And there goes all of your past penny profits...and then some.
This is all just corrupt manipulation (on NO NEWS); there is no denying. Perhaps shorts will win this little battle, but in the end the science and longs will win the WAR! And to this as well, there's NO DENYING!
I think that would be an incorrect assumption.
You have people believing in the "news leak" scenario in both situations. My belief is when a stock moves on no news, it's simply being manipulated. MMs and hedgies need their volatility fix daily! Junkies they are!