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WoW!! This is building very nicely to a HUGE surge in 2017. The silence is so dramatic. When it is broken we will see leaps and bounds in the right direction.
Onward and upward!
"Anavex Life Sciences WILL START a U.S. multicenter Phase 2 clinical trial of ANAVEX 2-73 for the treatment of Rett Syndrome"
From the sound of this it appears that on Sept. 11 we will still be waiting for Rett trial to begin. Not a big deal. Means no chance if data this year. But it's a short trial, so data will be here quickly.
Great find!
"We are entering the second half of 2017 with our strongest balance sheet to date, which allows the Company to execute the Phase 2 clinical trial in Rett syndrome...as well as the Phase 2/3 clinical trial in Alzheimer’s disease and the Phase 2 clinical trial in Parkinson's disease"
This sentence says that these trials will start in the second half of 2017.
"The respective trial designs are based on broad genomic and biomarker characterization, pharmacokinetic and pharmacodynamic modeling including data from patients in previous ANAVEXâ„¢ 2-73 trials, as well as preclinical translational science."
The trials are already designed...past tense. We are very close indeed.
Standby for ignition.
Totally agree with you 100%
Seems like wherever they are pulling their quotes from is an old source. For instance:
"When Melbourne was selected as the first city in the world to test Anavex a year ago,"
They were not selected a year ago. That doesn't mean the info isn't still accurate. And it's very possible that the Rotary put together this invitation all on their own to drum up excitement for the meeting.
Guess we'll find out Tuesday (our time).
Very happy to see the LPC deal working as intended. Great way to keep others out of our business till WE feel the time is right to parter.
Going to be lots of competition when it comes time for AVXL to court potential partners. There will be a very long line of anxious BPs jockeying for position. AVXL going to break their hearts.
Hopefully Missling and the rest of the board will eventually get the increase in compensation they deserve for navigating these waters with such skill and cunning.
GO AVXL!!!
If someone wants to think that Missling, MacFarlane, Dr. Cole, and a long list of others representing AVXL are involved in an organized, vast conspiracy to pump up a stock, all the while knowing 2-73 is actually failing in trials, then God help you.
They have ALL made clear, unambiguous statements recently regarding the continuing success of 2-73 in the current trials, as well as planning for upcoming expanded trials based on their current successes.
Either you believe what ALL OF THEM are saying... or you believe that ALL OF THEM are lying. No two ways about it.
They are not lying.
It will be extremely positive. And it will all be info we already know.
I agree totally that it is still very nice to hear this repeated. Just like Missling said at the Jefferies conference. The 104-week trial participants are "continuing to IMPROVE".
It's only a matter of time before we get great news updates. However, unless Missling was totally incorrect in his timeline/sequence of events, we will not be ramping up for AD 2/3 trial till several other things have happened.
Of course work is being done right now to develop and plan for the AD trial, but HIGHLY unlikely that they would share that info at this stage. Especially since the plans could change in the months ahead before the start of the trial. It would make the company look wishy-washy.
Also, I doubt they want to tie themselves down to a timeline more specific than the "before the end of 2017" date they have already given.
But again, look forward to hearing his discussion. Nice to see AVXL getting the message out.
I'm sure he will talk generally about his hopes and possibilities of 2-73. But pretty much everyone who follows this board already knows all of that. Extremely unlikely that there will be anything discussed that we haven't already heard and discussed here ad nauseam.
Looks more like he is talking about what kind of approach AVXL is taking to attack AD. Not results of the study. Not plans for 2/3.
The title says it is going to be a discussion about how 2-73 works (method of action).
RE-HASH.
I agree that McFarlane is working on developing 2-73. It's a HUGE leap to assume we will get details of the upcoming trial at this meeting. It is extremely more likely that he is going to re-hash old news for this group, many of whom don't know a thing about what 2-73 does.
We have been told (Jefferies 2017) that the Forst catalyst to expect this year is PK/PD data. Only after that will Rett trial begin. After all of that we will see Parkinson's trial start. Finally, we will see the 2/3 AD trial begin.
I wouldn't look for anything specific about the upcoming trial till the very end of the year. Definitely not at a Rotary meeting in August.
This is IMO of course.
Do you have a direct line to McFarlane?
I'm just being a realist.
Anyone who is feeling "impatient" should really go and re-listen to the Jefferies 2017 conference presentation. Good stuff!
Sure did... may I say:
HaHaHaHaHa!!!!!
Rotary meeting will be a NON-EVENT. Sad to say, many here will have built it up to a huge expectation only to have their hopes dashed again.
Good god y'all. Try to be cool. Keep it together. News will come when it comes. And it ain't coming from this meeting's forum.
As to the other points you're trying to make about how the results will look...you're wrong. Results will be good, not ho-hum as you are trying to describe. Dramatic, great news coming shortly IMO.
You yourself just said "if it results in a material impairment". Translation: if the news is bad it must be released immediately.
Also, they have stated several times during the "quiet period" that things are continuing to go well. Statements have been made about doing three trials this year. Also, Missling himself said that in the 104-week extension the participants are "continuing to improve". By law he cannot make such statements if he knows that they are in conflict with the actual data.
So, back to my original point...
The news IS good. Either you believe that or else you BELIEVE that soon Missling will be sitting in prison. I think the latter is preposterous.
If the company knows of "bad information" that would definitely be material information that would by necessity need to be disclosed immediately.
If they had "good information" they would need to disclose it in a timely manner as well, unless there is a legitimate business reason for waiting (i.e. Patent, partner talks, licensing deal).
If the company intentionally chose not to release this information they are liable for prosecution. At the same time, we know definitely that there is SOME KIND of information out there since the trials/analysis have continued. Nobody here seriously believes that the company is breaking SEC rules and is going to go to jail. That's ridiculous. I know it happens, but it's not happening with AVXL.
Q: What does that leave you with???
A: There IS news. It IS good. And...there must be a solid business reason for waiting to release the good news. The only room for speculation here is what is the reason they are withholding release of the GOOD news??
Going to be awesome finding out. Should know very soon.
GLTAL!!
I doubt whether we will see any kind of PR about the patent next week. The report is for the quarter ending 6/30/17. The patent happened after that.
Besides...from looking at the timeline with vTv's patent, it looks like we shouldn't expect a patent PR till around ~Sept 1.
I could be totally wrong, but don't want to get my hopes up for news that will be coming later than I thought.
They did 2a only.
2a was broken up into two parts (for confusion's sake they were referred to as "a" and "b")
2a(part a) was 5 weeks
2a(part b) was 26 weeks
Then they extended the 26 week trial to 52 weeks
Then they extended it again to 104 weeks.
For those who may be wondering about how long it could be before we hear about the patent... using vTv's recently PR'd patent... here's how it went:
08-01-2017: Patent Issue Date Used in PTA Calculation
08-01-2017: Recordation of Patent Grant Mailed
07-13-2017: Email Notification
07-12-2017: Issue Notification Mailed
06-30-2017: Dispatch to FDC
Now overlay that graph with the expected decline in a mild to moderate AD patient over that timeframe. We're waiting....
So what you are saying is that if the news is "positive" it must be totally and unambiguously positive. No room for negativity or doubt.
I like the way you think. I agree with that. The news must be very good indeed.
Missling stated that the trial participants were "improving".
Can you tell me, what are you hoping to accomplish with your posts? You're obviously not invested in this stock. Why all the effort?
Exactly. Imagine how the price swings you just described compare to a swing upward to the $10, $20, $40 prices in the long term! And that would just be the beginning if we shoot for the moon. (Can you say $300/share?!?)
Owning long shares and simply being confident in your DD and having the nerve to hold through the manipulation will pay off tremendously.
This is all assuming that the Long investor's DD was correct. However, every time we take another step it only confirms that the early testing results were correct. 2-73 is working as hoped (so far). A long way to go still, but looking great right now.
Just a different approach with a different timeline. If you can make some dough playing the daily/short term fluctuations, more power to you.
That's just not for me...maybe it should be. I just don't need the daily hassle. I'm happy to wait.
The longer it takes...imo...the bigger and better and more dramatic the news is going to be.
No problem waiting for the rich rewards of being Long and patient.
I don't pay ANY attention to price manipulation. It is powerless against real, substantial news. I don't mean The kind of "nothing" news we have gotten so far. Not "fluff". I'm waiting for the real news coming in the months ahead.
News is real. It makes a real difference in pps in the long run. Sure, there's small change to be made in the interim while we wait for the real show. But I'd rather just research, verify, invest, and wait for what I KNOW is coming.
Go LONGS!!
To each his own.
Will we get some big news in the next week?
Right, but a generic of an orphan drug is not allowed for 7 years I believe.
Since they have orphan drug status, I believe it changes everything.
If they get approval for 2-73 alone for treating Rett syndrome they have exclusive rights for treating Rett. No other drug will be approved for that indication.
If someone else made and sold generic 2-73 for another indication it could be prescribed "off label" for Rett. It seems to me that the FDA would be obligated to not allow that to happen by disallowing others to produce generic 2-73.
Am I off on this understanding?
Long positions are a noble investment. It means you are looking to make money because what you invested in is increasing in value. You earn a return on your investment without anyone needing to lose anything.
Shorting is ignoble. You want someone's investment or company to fail. You want to get money for yourself at the expense of someone else's loss.
I think your calls should do well for you. We may not have results out by then, but we should be underway with the three trials by then.
Those catalysts plus whatever other good developments that are possible. No reason to start doubting (not that you are). Should see some good things start happening very soon. Otherwise we may be talking differently soon.
Totally agree! I'm hoping we start seeing movement in the right direction starting in the next two weeks. If we want any chance of seeing data in Dec/Jan the Rett trial will need to start VERY soon.
C'mon! We're ready for the big show!!
Patent news has stirred up the hornets nest! FUD flying everywhere! Hahaha! Reeks of desperation from the B^$h€r$.
Not actually due till August 14th.
In 2015 they PR'd the 13f on Aug 17th.
In 2016 it was PR'd on Aug 10th.
My guess is that this year it will most likely be PR'd next week.
So exciting!
Hopefully they don't sell out so early. Waiting for a bit longer before finding a partner will pay off big time.
Last entry for Plus patent says"Dispatch to FDC". Here's the explanation I found:
1309 Issue of Patent [R-5]
*******
When the issue fee is paid and all other requirements have been met (e.g., drawings) within the time allowed by law, the application is forwarded to the printer for Final Data Capture (FDC) and final issue preparation. At this point, the application can only be retrieved if it is withdrawn from issue. The application is assigned a patent number and issue date about ten days before the application issues as a patent, and an Issue Notification is mailed to inform the applicant of the patent number and issue date. A bond paper copy of the patent grant is ribboned, sealed, and mailed by the Office of Patent Publication.
From the USPTO website:
07-31-2017: Application Is Considered Ready for Issue.
More likely that we will wake up one day soon and see a PR regarding start of Rett trial.